How Does Kratom Relieve Pain?

By Dr. C. Michael White, University of Connecticut

Kratom doesn’t contain just one active ingredient; rather, it is made up of many substances that induce effects in the body. This is very common for natural products, since the cells of the plant make a variety of chemicals for different purposes.

When the body is experiencing pain, it releases hormones called endorphins that stimulate opioid receptors to mildly reduce the transmission of local pain sensations to the brain. This same process also causes the release of the neurotransmitter dopamine, inducing a feeling of pleasure to neutralize the pain.

Traditional opioids, like morphine and fentanyl, stimulate these same receptors to such a degree that they more potently numb pain, induce a euphoric feeling that can lead to addiction, and suppress the drive to breathe, which can result in death.

One of the key constituents of kratom is an organic compound called mitragynine. It interacts with the same opioid receptors as morphine and fentanyl, but does not recruit the beta-arrestin-2 (the reason for breathing suppression). As a result, kratom can provide pain relief with a lower risk of slowed or stopped breathing compared to traditional opioids.

Kratom also contains a small amount of 7-hydroxymitragynine, which is thought to more potently stimulate opioid receptors, leading to a greater risk of opioidlike adverse events.

One of the risks associated with kratom use is that products can differ dramatically in the doses of 7-hydroxymitragynine. In other words, one kratom product could be more dangerous than another. When kratom is used in high doses, it can lead to seizures and other issues. Since kratom products are not FDA-regulated, there is no uniformity to the products.

Is Kratom Legal?

Kratom’s current legal status is complicated. Kratom is not a prescription or over-the-counter drug, and while it is derived from a plant, it does not meet the FDA’s definition of a dietary supplement, food or food additive.

Natural products marketed in the U.S. before Oct. 15, 1994, were grandfathered in under the FDA’s list of dietary supplements. But since kratom came on the market later, the FDA would have to find, based on a history of use or other evidence, that when used under the conditions recommended or suggested in the labeling, the natural product can reasonably be expected to be safe – like the FDA does for all new dietary supplement ingredients.

In 2016, in response to increasing calls to poison control centers, the Drug Enforcement Administration sought to ban kratom by making it a Schedule I drug. This means the agency felt it had no currently accepted medical use and a high potential for abuse. But backlash from the public and support from congressional members made the agency postpone a final decision. So kratom is currently listed as a “drug of concern.”

Seven states and some counties have banned the sale of kratom. But in 2023, the U.S. House and Senate proposed legislation to prevent the FDA from regulating kratom more stringently than they do a dietary supplement or a food additive, in order to keep the product accessible to consumers.

Kratom Research Lacking

A 2024 literature review concluded that there are no clinical trials evaluating the effects of kratom on chronic pain management.

Research on acute pain tolerance in people is limited to a 2020 study that found participants who took a dose of kratom could endure immersion of their arms in an ice bath for significantly longer than those who did not take a dose of kratom. However, this study was conducted on chronic kratom users, and their pain tolerance before they took their dose for that study was much lower compared to that of non-kratom users in other studies. This suggests that chronic kratom use is lowering people’s background pain tolerance.

This is similar to another study showing that when people tried to stop taking kratom after chronic use, they experienced significant pain throughout their body. This increased sensitivity and reactivity to pain, called hyperalgesia, also occurs with traditional opioids and is one of the reasons why people who use them chronically find it so difficult to get off them.

Taken together, these studies suggest caution before starting kratom as a treatment for chronic pain, especially if safer methods such as acetaminophen, icing and heating, and physical therapy can suffice.

Some people also claim that kratom could be a natural treatment for withdrawal and other effects of opioid use disorder, the clinical term for opioid dependence.

A few methodologically weak studies reported that participants were able to reduce or stop their use of traditional opioids and that kratom reduced the severity of opioid withdrawal symptoms. These include diarrhea, runny nose and eyes, shaking, fast heartbeat and anxiety.

However, there are no clinical trials comparing kratom to methadone, buprenorphine or naltrexone, the FDA-approved treatment options for opioid use disorder. So if patients have access to traditional FDA-approved therapies, these are the safest and best place to start.

If traditional options are not effective or patients cannot access them due to financial or logistical barriers, kratom may be a potential alternative to illegal opioid products, but it is certainly not risk free. Speaking with a health care professional is critical before making treatment decisions.

C. Michael White, PharmD, is a Distinguished Professor and Chair of the Department of Pharmacy Practice at the University of Connecticut School of Pharmacy. He has been studying the science behind kratom to help consumers better understand its potential benefits and adverse effects.

White’s research work has been funded by the Agency for Healthcare Research and Quality (AHRQ), Donaghue Foundation, Pfeiffer Foundation, and American College of Clinical Pharmacy.

This article originally appeared in The Conversation  and is republished with permission.

My Story: Kratom Helps Treat Fibromyalgia

By Jim Hunter

The following narrative is not meant as medical advice. I am not a medical professional. I am simply relating my own experience.

Most of my adult life I have suffered from a variety of symptoms that were never diagnosed by any of the doctors I saw. Eventually, I became aware that these symptoms seemed to be consistent with the list of symptoms that appear under the heading of fibromyalgia. The most conspicuous symptom was painful muscles all over my body. The one symptom often associated with fibromyalgia that I did not have was insomnia.

Do I actually have fibromyalgia? I don’t know. What I have is an assortment of symptoms that, when compared to a checklist for fibromyalgia, make it look pretty close to that mysterious affliction.  Since there seemed to be no reliable objective signs of fibromyalgia, and I seemed to have almost all the subjective ones, it seemed reasonable to diagnose myself as having it.

I treated it for a long time (years) by taking more ibuprofen than is recommended for pain relief. The ibuprofen did help some, so I took more than I should have. I am not recommending anyone else do this, but I didn’t see an alternative at the time.

Then I discovered kratom. I don’t recall how I happened to run into it. But I discovered that when I took small doses of kratom regularly throughout the day, the fibromyalgia symptoms simply went away. Above all else, I didn’t hurt anymore.

Kratom even cleared up the stomach and intestinal problems. That was a surprise. I figured that anything that tasted as harsh as kratom wouldn’t help my stomach, but it did.

As long as I didn’t take too much kratom, I didn’t have any loopy feelings. I didn’t mind the slightly euphoric sensations it sometimes generated, but I learned to fine tune it so I didn’t experience that. It simply took away all the muscle aches and pains, fatigue and stomach problems. I felt normal again and was productive.

A Complication

That happy state facilitated by kratom lasted for years. But then I ran into a glitch. I got an inguinal hernia that strangulated. The surgeon was able to push it back in, but that was clearly just a temporary solution. Clearly, I needed surgery. One can die a nasty death from a strangulated hernia.

There was a complication about whether the local hospital could do the operation or whether my condition would require a bigger hospital with an intensive care unit. They eventually agreed on the local hospital (which is what I wanted), but the only glitch was that I had barely mentioned my use of kratom and sort of played it down. I was pretty sure most of the professionals in the medical field would be suspicious of it. Kratom is, after all, reported to have a mild opioid-like effect.

I’m 83 years old. I was perfectly willing to take any reasonable risk in surgery. I am not going to live forever, and I suspect that the end will not be decades off.

But I did feel obligated to the hospital that agreed to do the operation. I had to either level with them about the kratom I was taking or get off it. I knew that if I explained everything in detail, it would raise questions again about who should do the operation and when. I imagined there might be an issue with a possible interaction of kratom with anesthesia.

I decided to get off the kratom, at least long enough for the operation. There might be some withdrawal symptoms, but they were described in the literature as mild to moderate and short lived.

So, I began phasing out my kratom, for which I calculated I needed about two weeks. Two weeks stretched into three and then four. I was feeling horrible – considerably worse than what was described as kratom withdrawal. This was neither short, nor mild or moderate.

Then my wife put her finger on the problem. The symptoms for withdrawal and fibromyalgia, though similar, were not exactly the same. I was experiencing less nausea, but more pain. The fibromyalgia was back in full force. At that point, as I saw it, I had no choice. I took a little bit of kratom once again and felt fine, except for the hernia.

It was while on the minimal dose of kratom needed for the fibromyalgia that I went in for surgery. After the operation, the anesthesiologist reported that her part of the operation went well. I was relieved. However, another problem emerged. An expected two or three-hour operation with laparoscopic surgery turned into a seven-hour ordeal.

I still cannot visualize the exact nature of the unexpected problem the surgeon encountered. Apparently, my bladder was drawn into and tangled up with the hernia. The surgeon, who had done this operation thousands of times, had never seen it before and nobody else had heard of it.

The surgeon was able to unravel the problem and repair the hernia. This led to yet another problem. I had expected to be in the hospital most of one day, but they kept me in the hospital overnight and, as far as I knew, might keep me hospitalized even longer.

By three in the morning, I was beginning to experience moderate to severe pain. The medication given to me by the night nurse didn’t touch the pain. I realized I had no choice. I had to confess my sin -- the incomplete and unsatisfactory way I told them about the kratom -- and plead for mercy.

I called in the night nurse and explained the whole thing. She was very nice about it, let the head nurse know right away, and notified the surgeon as soon as he arrived in the morning.

To make a long story short, arrangements were made for me to be released from the hospital so I could resume my regime of small doses of kratom.

I had lots of minor aches and pains from being worked on so hard and so long during the operation, while in an awkward position. They had raised my legs a considerable angle to the ground, expanded the inner cavities of my body with CO2, and done God knows what to separate my scrotum, testicles and whatever else from the hernia. But with some Aleve, these were now manageable pains. 

Do I have any advice? Not really. The nearest thing I can offer is to say that, should the situation rise again, I would simply tell the medical people about my dependence on kratom. And if they insisted that I get off it before they would do the surgery, I would not have the surgery done.

Jim Hunter lives in Maine. He is a retired social worker.

Do you have a “My Story” to share?

Pain News Network invites other readers to share their experiences about living with pain and treating it.

Send your stories to editor@painnewsnetwork.org.

Should Suboxone Be Used to Treat Kratom Addiction?

By Pat Anson, PNN Editor

A man with a history of substance abuse – including addiction to kratom – has been successfully treated with buprenorphine/naloxone (Suboxone), according to a case study published in the journal Cureus.  Suboxone is a medication that is normally used to treat opioid use disorder.

Kratom is not derived from the opium poppy and is not an opioid. It’s an herbal supplement that comes from the leaves of a tree in southeast Asia, where it has been used for centuries as a stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction.

The unidentified patient in the case study has a history of using cocaine, marijuana and alcohol, and suffers from anxiety and depression. He was introduced to kratom 12 years ago by his brother for stress relief and as a substitute for oxycodone. Over the years, the patient used more and more kratom, at one point spending up to $600 a week on kratom supplements.

After several failed attempts to wean himself off kratom, which resulted in severe withdrawal symptoms, the patient went to see his primary care physician, Dr. Paul Remick, one of the study’s co-authors. It was Remick who suggested that Suboxone might help him quit kratom.

“He’d been struggling with depression, anxiety, all these various issues. He was pretty reluctant to try therapy like Alcoholics Anonymous or trying to speak to a therapist,” explained lead author Martin Arhin, a medical student at the University of North Carolina at Chapel Hill. “Dr. Remick suggested Suboxone, since kratom has some like opioid-like properties. He felt like it could potentially work. And fortunately, it did.”

After 23 weeks of using Suboxone, the patient’s withdrawal symptoms subsided and he stopped using kratom. He’s also been successfully tapered off Suboxone, a drug that many people wind up taking for life.   

Suboxone is only approved for opioid use disorder and there is no clinical evidence that it can treat kratom addiction. Such a use, while legal, would be considered “off-label” by the FDA. But based on this one anecdotal case, Arhin and his co-authors say Suboxone could be a treatment for kratom dependence.

“Currently, there is no established evidence-based consensus for the treatment of kratom addiction and withdrawal, leaving individual providers to decide on the appropriate course of action,” they wrote. “We recognized the patient's dependency on kratom and subsequently implemented a treatment plan utilizing buprenorphine/naloxone, which effectively alleviated withdrawal symptoms and supported the patient's abstinence from kratom. We suggest that this drug combination may be a potential treatment for kratom addiction.”

‘Kratom Saved My Life’

Ironically, many people use kratom as an alternative to Suboxone. In a 2016 PNN survey of over 6,100 kratom users, nearly ten percent said they used kratom primarily as a treatment for opioid addiction. Most said it was very effective (91%) in easing their withdrawal symptoms and worked better than Suboxone, with fewer side effects.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years. Subutex, methadone, total abstinence and the 12 step program. Each time I failed. After 2 years of Suboxone, I stopped treatment and began using kratom,” one respondent told us.

“Because of kratom, I no longer have to worry about heroin (or methadone or Suboxone) making me sick. I've been clean for 2 years. I can hold a job now, and I only use it when I need pain relief or need to relax,” another respondent wrote.

“I became hooked on oxycodone and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used kratom to cure that,” another patient said.

“Kratom truly saved my life. I've always suffered from extreme anxiety, but it has decreased drastically since taking it. Withdrawals from opiates and Suboxone are awful. I would not have been able to get clean without kratom. I'm confident in saying that if you make kratom illegal, the number of overdoses will rise,” wrote another kratom user.

The DEA and FDA have tried to make kratom illegal by having it declared a Schedule I controlled substance. So far, those efforts have failed due to a public backlash.

Kratom is sold legally in most U.S. states, but a handful of states and cities have banned it over concerns about addiction and overdoses.  About 100 deaths nationwide have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.

About two million Americans use kratom, primarily to treat chronic pain. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

Although many people use kratom to self-treat opioid addiction and ease withdrawal symptoms, the FDA won’t allow kratom vendors to advertise or promote kratom for addiction treatment or any other medical purpose. This month, the FDA sent a warning letter to the Sunshine Trading Company in Colorado, warning it to stop promoting its kratom products for “opiate withdrawal.”

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal,” the FDA said.

In recent years, several other kratom vendors have received similar warning letters from the agency..

‘Super High Concentration’ of Kratom Involved in Georgia Man’s Death

By Pat Anson, PNN Editor

The family of a 23-year-old Georgia man who died last year after ingesting a potent kratom extract has filed a wrongful death lawsuit against a kratom manufacturer and a trade association that promotes the company for following good manufacturing standards.

Ethan Pope was found dead on the kitchen floor of his apartment on December 3, with his dog by his side. Pope had recently purchased bottles of Black Liquid Kratom made by Optimized Plant Mediated Solutions (OPMS).

An autopsy concluded that Pope died as a result of cardiac arrest due to mitragynine intoxication, and his death was ruled an accident by the Georgia Bureau of Investigation.

Mitragynine is an alkaloid and one of the active ingredients in kratom, which comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

ETHAN POPE

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. It is sold legally in most states, including Georgia, where it can be purchased at gas stations and smoke shops.

Kratom is normally consumed as a dry unadulterated powder, but the Black Liquid Kratom allegedly consumed by Pope is a highly concentrated 50:1 extract, with up to 375mg mitragynine per bottle.

“This super high concentration can be felt with just a drop or two of the extract added to your tea or coffee. Even veteran users of kratom should start slow with this liquid extract because it is so different from other liquid extracts on the market,” is how one kratom vendor markets Black Liquid Kratom.

Another kratom vendor specifically cautions that OPMS extracts are “too strong for use on a daily basis.”

It’s not clear how long, how often or why Pope had been taking kratom, but at a news conference this week his parents said they found a to-do list in his apartment that included the words “Stop taking kratom.”

The family’s lawsuit was originally filed in May and an amended complaint was filed this week, naming over a dozen different individuals, vendors and organizations, including OPMS and the American Kratom Association (AKA).    

“You don’t expect to go into a store and find something similar to heroin between energy drinks and breath mints. We intend to hold every single person and entity involved in the distribution and sale of these products responsible,” attorney Matt Wetherington said in a statement.

The lawsuit drafted by Wetherington makes frequent references to kratom as a heroin-like substance, but there is no relationship between the two. Heroin is derived from opium plants, while kratom comes from mitragynine speciosa trees. Both act on opioid receptors in the brain, however, which has led to claims that kratom is an opioid.

OPMS has not commented publicly on the lawsuit, and the AKA issued a short statement saying it rejected the lawsuit’s claims and filed a motion to be dismissed from the case.

‘100% Natural and Never Adulterated’

OPMS is featured on the AKA’s website as one of the first kratom vendors to comply with its Good Manufacturing Practice Standards Program (GMP), an effort to enhance the safety of kratom products. To get “GMP Qualified” status, vendors have to agree to annual audits, inspections and testing of every production lot of kratom.    

“Optimized Plant Mediated Solutions has been the leader in the Kratom and Kava extract industry since 2010 due to its unique cold water extraction process. All O.P.M.S. products are 100 percent natural and never adulterated,” the AKA says on its website, which includes a link where OPMS products can be purchased directly from the company.

OPMS did not immediately respond to a request for comment from PNN. The company’s website cautions consumers that “several companies illegally counterfeit” its products, adding “dangerous ingredients” that pose a “serious health threat.” It urges consumers to report any suspicious products.

Taken in low doses, kratom acts as a mild analgesic and stimulant. Consumers generally take higher doses to combat severe pain and cravings caused by substance addiction. Most users do not experience a “high” or euphoria after taking kratom.

The Food and Drug Administration has not approved kratom for any medical use and vendors can run into trouble with the agency if they claim kratom can be used to treat health conditions. The FDA tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. The FDA says kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

About 100 deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  A toxicology test on Ethan Pope found antihistamine and antidepressant medications in his system, but no illegal drugs or alcohol were detected.

Feds Warn Kratom Vendors About Marketing for Addiction Treatment

By Pat Anson, PNN Editor

The Food and Drug Administration and Federal Trade Commission have sent warning letters to four kratom vendors saying they are in violation of federal law for selling “unapproved new drugs.” The letters to Herbsen Botanicals, Klarity Kratom, Kratom Exchange and YoKratom primarily focus on their marketing of kratom as a treatment for opioid addiction.

Kratom is a dietary supplement that comes from the leaves of the mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction. Kratom is sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions.

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses,” the agencies said in their letter to Herbsen Botanicals. “Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health.”

The letter cites several blog posts on Herbsen’s website, which claim that kratom is a “common recommendation to manage opioid addiction” and “delivers similar effects” as morphine and codeine. Herbsen also has a lengthy disclaimer on its website saying such statements “are not intended to diagnose, treat, cure or prevent any disease or ailment.”

The FDA has tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. Having failed to achieve that goal, the agency has resorted to occasional warning letters, import alerts and seizures of kratom.   

In a recently updated online fact sheet, the FDA said kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

‘Kratom Saved My Life’

Addiction treatment is one of the main reasons that people use kratom. In a large PNN survey of over 6,400 kratom users, about one in ten said they primarily used the plant to treat opioid addiction or alcoholism. Several said it was more effective than methadone or Suboxone in relieving withdrawal symptoms.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years,” one respondent wrote. “After 2 years of Suboxone, I stopped treatment & began using kratom. I've made more progress toward my ultimate goal of total sobriety in 2 years of self-administered kratom then 5+ years of suboxone & methadone treatment.”

“Due to 3 surgeries, I became hooked on Oxy and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used Kratom to cure that,” said another.

“Not only is this a wonderful alternative for people with chronic pain. but this also could greatly reduce our heroin epidemic crisis going on in our country. After years of being physically dependent on legally prescribed Suboxone, I was unsuccessful at my attempts to get off of them. Kratom made it possible, and I believe would help others trying to get off any opiates and live full and productive life,” another poster said.

In recent testimony before Congress, FDA commissioner Dr. Robert Califf warned that kratom was a harmful substance that has caused “real adverse events, real negative things that have happened to people.” Califf also said the agency may need new authority from Congress to regulate kratom and other supplements that are not “traditional drugs.”

FDA Head Wants New Regulations for Kratom and CBD

By Pat Anson, PNN Editor

The head of the Food and Drug Administration says his agency will need new authority from Congress to regulate both kratom and cannabidiol (CBD), two natural substances used by millions of Americans to self-treat their pain and other medical conditions.

FDA Commissioner Dr. Robert Califf testified on Thursday before a House Appropriations subcommittee, where he was asked why the agency was slow in developing new regulations for CBD and why it remained opposed to the use of kratom. Califf said new regulatory pathways were needed for both substances because they fall between the cracks of existing law that gives the FDA broad authority to regulate food and drugs.

“I don’t think the current authority we have, on the food side and the drug side, necessarily gives us what we need to have to get the right pathway to move us forward. We’re going to have to come up with something new. I’m very committed to doing that,” said Califf.

Califf was recently confirmed by the U.S. Senate as FDA commissioner, a job he previously held under President Obama. He noted that little progress had been made at the FDA in regulating CBD and other cannabis products since he left the agency.

“You know, when you come six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over,” said Califf.

Some of the difficulty in regulating CBD comes from passage of the 2018 farm bill, which legalized hemp under federal law. At the time, it was believed that hemp had little or no psychoactive properties and would be relatively harmless. However, as PNN has reported,  some cannabis companies have found ways to concentrate delta-8 tetrahydrocannabinol (delta-8 THC) derived from hemp and are using it in edibles to give consumers a mild intoxicating effect.

The FDA considers delta-8 THC an unapproved drug, but because it comes from hemp – a legal substance – its regulatory status is unclear.

“The amazing plethora of derivatives of the cannabis plant is really quite profound and astounding, and already in widespread use in a variety of means. Most of the FDA effort so far has been spent on research to figure out what the risks, if any, are of various uses of this material in its different forms,” said Califf. “The research so far has shown that there are some risks with CBD. And so, we’re going to need a different pathway than just the standard food pathway.”

FDA Kratom Info ‘Extremely Antiquated’

Califf took a similar stance on kratom, an herbal supplement that comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction — even though the FDA has not approved kratom for any medical condition.

In a recently updated online fact sheet, the agency said kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

That brought a rebuke from Rep. Mark Pocan (D-WI), who has supported efforts to keep kratom legal. He called the FDA’s position on kratom “extremely antiquated.”

“That update was not much of an update and I think it’s being very unfair to the consumers who are legally consuming kratom in this country,” Pocan told Califf.  “Honestly, there are not only arguable conclusions (in the update), but you are linking to outdated, incomplete and inaccurate information.“

“I hope to come back to you on kratom in a couple months,” Califf replied. “There are millions of people using kratom. We do have real adverse events, real negative things that have happened to people. And it does interact with multiple neurotransmitters.”

Kratom is banned in several states, but a federal effort to ban kratom nationwide in 2016 failed due to a public outcry. The Department of Health and Human Services (HHS) later withdrew an FDA request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused. A former HHS official said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse (NIDA) concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects. NIDA recently had a public hearing on kratom to further explore its therapeutic uses.

“We’ll continue to work with NIDA and we’ll go where the science takes us,” Califf said. “But like I said with regard to cannabis products, we need something different with these kinds of products that are not traditional foods, not traditional drugs.”

Study Warns of ‘Kratom Use Disorder’

By Pat Anson, PNN Editor

Nearly a third of people who use the herbal supplement kratom develop symptoms of withdrawal and tolerance that could be signs of kratom use disorder (KUD), according to a small survey by the National Institute on Drug Abuse. Withdrawal symptoms included gastrointestinal upset, restlessness, anxiety, irritability and fatigue.

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction.

NIDA researchers recruited 129 past and current kratom users in the U.S. to participate in the online survey, asking them about their symptoms and demographic information.

The study findings, recently published in the Journal of Addiction Medicine, found that over half of kratom users showed no signs of addiction. But 29.5% met the diagnostic criteria for KUD, such as increased use, tolerance, withdrawal, unsuccessful attempts to quit, and craving. Most reported KUD symptoms that were mild or moderate, with about one in four with KUD having severe symptoms.  

Nearly 10% of participants also reported “psychosocial impairments,” such as decreases in social, occupational, or recreational activities because of their kratom use.

“As assessed here, tolerance and withdrawal are primary KUD features rather than psychosocial impairments. As kratom is often used among persons with a myriad of health conditions, clinicians should be aware of and assess for kratom use and withdrawal,” wrote lead author Kirsten Smith, PhD, who heads much of the kratom research at NIDA.

Federal health officials have long taken a dim view of kratom and made unsuccessful attempts to ban it. In 2018, former FDA Commissioner Scott Gottlieb, MD, claimed that kratom was an opioid, addictive, and should not be used to treat any medical condition.

“Kratom use disorder” is a relatively new diagnosis and does not appear often in medical literature.  One of the first references to it is in a 2019 study that called kratom an “emerging public health threat.” Researchers said healthcare providers need to be aware that kratom use was “typically accompanied by increasing tolerance and dependence making it highly problematic.”

A kratom advocate said the new NIDA study shows the risk of kratom addiction is low and that symptoms are often mild. 

“I thought the results of this research were particularly interesting because of the growing number of addiction recovery centers expanded their service-for-hire to include kratom use disorder (KUD) and characterizes this condition as mirroring opioid use disorder (OUD) that requires intensive drug interventions of different substances,” said Mac Haddow, a lobbyist and Senior Fellow for the American Kratom Association, which represents kratom vendors and consumers.  

“Importantly, the study concludes that tolerance of kratom over time, and withdrawal from that level of dependence are the primary outcomes rather than psychosocial impairments that are largely debilitating among drug addictions. The study also recognizes that kratom continues to be a harm reduction alternative for those suffering from polydrug use addiction issues and that accounts for its increasing use as the drug overdose crisis deepens in the U.S.” 

Kratom is often used as a treatment for addiction. A 2016 PNN survey of over 6,400 kratom users found that nearly 12% used it to reduce their cravings for alcohol or opioids. Nine out of ten said kratom was “very effective” at treating their substance use disorder. And over 98% of all respondents don’t believe kratom is harmful or dangerous.

Kratom Candy: A Sweet Alternative to Powder

By Crystal Lindell, PNN Columnist

I first started taking kratom for my chronic pain almost four years ago. I have debilitating pain in my right ribs that has been diagnosed as intercostal neuralgia. Until I found kratom, nothing sold over the counter had ever helped at all — not even the magic mix of Tylenol and Advil that doctors have been touting of late.

The only issue with kratom is that the leaves, when ground up into powder, taste like dry dirt. But when you’re in pain, and you find something that works, you tend to overlook things like horrible taste. I got used to it by the “toss and wash” method -- putting a spoonful of kratom powder under my tongue and then washing it down with a non-carbonated beverage, usually Gatorade.

But it’s not ideal, and the bad taste makes it difficult to recommend kratom to people who could benefit from it —  especially as doctors continue to limit access to prescription pain medication.

So when I recently got the chance to try some kratom candy and other new formulations, I was excited. Kratom taffy, kratom chocolate, kratom soft gels and even a kratom seltzer? Are these the kratom edibles I've been waiting for?

In short: Sort of. 

Below I offer a review of each one, ranking them on a 5-star scale and offering pros and cons for each product.

But first, a bit of context. I went into this comparing all of the items to my personal kratom go-to: loose kratom powder. The powder tends to work for my pain within about 3 minutes and it’s relatively cheap. I usually get it in bulk from my local smoke shop for about $150 a kilo, which comes out to about 70 cents for a 5 mg. dose. I usually take a dose every 3-5 hours while I’m awake, depending on how much pain I’m in.

Readers should also know that this review is not sponsored by any kratom vendors or brands, although the companies did send me these items to try for free.  We reached out to several kratom vendors and asked them to send us samples, and CBD Kratom and PurKratom obliged.

Let’s look at the various new kratom products.

Raw Kratom Taffy ★★★★★ 5/5 stars

Let’s start with what ended up being my favorite new product: Raw Kratom Taffy.

CBD Kratom sells it in multiple strains, so consumers can purchase a piece of taffy in red maeng da, white maeng da, green maeng da, and gold maeng da.

According to the ingredient list, a 20 mg. piece is one serving. However, I only ate about a 1/3 of a piece and it was enough to tackle my pain on an especially bad evening. Since each piece costs about $6, it’s good to know that it could be used as more than one dose.

Pros: It worked really well, hitting me in less than 30 minutes. And I did like the flavor, which the ingredient list said was created with fruit juices. It doesn’t taste like candy, but it doesn’t taste particularly bad and that’s a massive accomplishment for any kratom edible.

I also really liked that it came in various strains, because I have a strong preference for red maeng da, while simultaneously hating white maeng. They all work differently for people, so being able to know which one I was consuming definitely elevated the experience.

Cons: The taffy itself was incredibly difficult to bite into and I felt like I was going to break my teeth trying to chew it. I’m hopeful that the company will be able to tweak the formula a bit to work on this. It’s also a little pricey compared to the powder. I don’t think I’d want to switch to something like this for all my kratom needs, but for occasional use it was great.

PurKratom Soft Gels ★★★★☆ 4/5 stars

These would have been my favorite item if they weren't so expensive. PurKratom has them listed at $79.99 for just 20 capsules.

Nearly $80 is just a tad more than I would be willing to pay on a regular basis. Especially since the soft gel capsules can't be split like a pill into multiple doses. And it would be difficult to recommend these to someone knowing they would have to spend $80 for their first order.

The capsules did work though, and they were much easier to get down than either kratom powder or the kratom edibles I tried. The company says they are made with “high concentrations of organic kratom extracts,” with each soft gel containing 33 mg of pure extract.

I would love to see these sold by strain like the taffy is, but the formula they did use worked for me. 

Pros: These are by far the easiest item to get down. It’s like popping some Advil liquid gels. I took one at a time, and it hit me within about 30 minutes, alleviating my pain without making me fuzzy or giving me a head rush. For anyone who could benefit from kratom, but who hasn’t tried it yet because they can’t stand the delivery method, these are a wonderful option.

Cons: The price is the biggest issue with the capsules for me. Although the soft gel formulation makes them significantly better than the kratom capsules already on the market — which are usually just kratom powder stuffed into capsules — at $4 for each capsule, that’s just too much to spend on a product that I can get significantly cheaper in powder form. 

Korthal’s Collection No 539 Kratom Seltzer ★★★☆☆ 3/5 stars

This item was especially intriguing to me, as it’s the first time I’ve ever come across a kratom drink.

Korthal's Collection has it listed at $35 plus shipping for a 4-pack of 16-oz. cans, which is a little high for my budget. The company says the seltzer is made with “75mg of full spectrum mitragynine per 16oz can” and is best used for “increased focus, mood elevation and energy boosts.”

Pros: It doesn’t taste that bad. It’s not refreshing exactly, but it’s not any worse than a bitter alcoholic beverage. It tastes kind of like a strong tea and definitely needs to be consumed chilled. I’d love to see them add a lemon honey flavor to the line-up.

Overall, a full can was very potent. I only drank about a 1/3 of a can and it hit me within about 20 minutes. My fiancé drank a whole can and really felt the effects, both on his physical pain and mood.

Cons: While the flavor wasn’t bad, it wasn’t exactly good either. There was a strong aftertaste and I felt the need to eat something else to get rid of it. While the cans tout the seltzer’s ability to lift your mood and give you energy, that wasn’t my experience. If anything, it was more relaxing and subduing.

Also, the price point is a little high. It’s just expensive enough that I’m not sure I would order it on a regular basis. However, if my local smoke shop sold individual cans, I could see myself grabbing one as a treat when I went in to purchase the powder.

Korthal’s Collection: No 395 Milk and Dark Chocolate ★★★☆☆ 3/5 stars

This is probably the item I was most excited to try. Kratom? Good. Chocolate? Good. Kratom Chocolate? It was okay.  

Korthal's says “these velvety chocolate bars are best for energy and may provide pain relief and mood enhancement.” The company has them listed at $20 for a single 1.3-oz bar and they come in both milk and dark chocolate. Each bar has 8 serving squares. The packaging says they have 25 mg. of mitragynine per serving.

Pros: This is something I could easily get my older relatives to try for their arthritis. The bars don’t taste anything like a regular chocolate bar, but they also don’t taste anything like plain kratom powder. They’re chocolaty enough to easily eat a square, even if you aren’t used to the taste of kratom.

However, I did find myself using a chaser afterward to get rid of the aftertaste. And while each bar is expensive, I would feel comfortable recommending these to someone who could try it out for just $20.

As far as potency and effect, one square was definitely enough, although like the taffy, it took about 30 minutes to feel the effect. For me, it gave me a bit of a disconnected head buzz while also relieving my physical pain.

Cons: Again, the price is a little high. While it’s about in line with a lot of CBD candy on the market, it feels expensive compared to kratom powder. Adding child-proof elements to these and other kratom candies would be a good idea.

I also wish the chocolate was sold by strain, like the taffy, because I’d like to have more control over which types of kratom I’m consuming and when.

Takeaways

In the end, I find myself still reaching for my trusty kratom powder from the local smoke shop, even though I still have some of the chocolate and taffy left over. The powder just works faster and it’s also significantly cheaper per dose. The fact that taking kratom under my tongue hits me in less than 3 minutes is just such a major advantage that none of these other products could compete with. That’s not the fault of the manufacturers, it’s just the nature of the products.

For someone who doesn’t need that instant pain relief though, a lot of these edibles work in about the same amount of time as any other pain medication, and I’m sure a lot of consumers would be fine with that.

If the gel capsules came down in price, I would likely buy those for myself on a regular basis. And even at their current price, I’ll probably buy some for my relatives who I think could benefit from kratom, but who just haven’t been able to get the powder down. My fiancé, who is also a chronic pain patient, really enjoyed the seltzer.

The bottom line is that all these products could be great alternatives for anyone who just doesn’t vibe with swallowing a spoonful of soil-flavored kratom powder.

It’s exciting to see how far the kratom industry has come since I first started using it almost 4 years ago. I have long hoped companies would venture into kratom edibles and better capsule products. Finally seeing those products develop is wonderful, and I can’t wait to see what comes next!

Crystal Lindell is a journalist who lives in Illinois.  After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome.

WHO Panel Finds Insufficient Evidence to Review Kratom

By Pat Anson, PNN Editor

An advisory committee of the World Health Organization (WHO) has concluded there is insufficient evidence to recommend a “critical review” of kratom, which potentially could have lead to international controls on the herbal supplement used by millions to treat pain and other medical conditions.

WHO’s Expert Committee on Drug Dependence (ECDD) recommended that kratom and its two active ingredients, mitragynine and 7-hydroxymitragynine, be kept under WHO surveillance. Under international treaties, WHO is required to give an annual assessment of psychoactive substances and advise the United Nations on whether they pose a public health risk.

The ECDD’s report said regular use of kratom can lead to dependence and mild withdrawal symptoms, but that serious adverse effects were rare. Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

“Kratom is used for self-medication for a variety of disorders but there is limited evidence of abuse liability in humans,” the ECDD said. “Kratom can produce serious toxicity in people who use high-doses, but the number of cases is probably low as a proportion of the total number of people who use kratom. Although mitragynine has been analytically confirmed in a number of deaths, almost all involve use of other substances, so the degree to which kratom use has been a contributory factor to fatalities is unclear.”

‘Great Victory for Kratom Consumers’

In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction. Kratom is legal in most states, although some states and communities have banned it. The Food and Drug Administration has tried -- unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

The ECDD report was cheered by kratom advocates, including some who believe the FDA asked WHO to review kratom.

“It is a great victory for kratom consumers, for science and for the truth,” said Mac Haddow, a lobbyist for the American Kratom Association, a group of kratom vendors and consumers. "There can be no doubt that kratom should not be scheduled and that it should be responsibly regulated to protect against dangerously adulterated kratom products."

In a notice published in the Federal Register in July, the FDA called kratom “an increasingly popular drug of abuse” and said it was being “misused to self-treat chronic pain and opioid withdrawal symptoms.” Over 8,500 people responded to the FDA notice, most of them critical of the agency’s stance on kratom.

“When the FDA proposes that a natural substance like kratom be banned it is not because it’s dangerous to the public, it’s because it poses a threat to the pharmaceutical industries profits. These people have a financial interest in stopping a safe and natural substance from competing with high priced drugs,” wrote one anonymous poster.

“I suffer from chronic pain from an illness that no medication was able to help except for opioids. I became addicted, I lost my home and my job, and I was homeless for years dealing with an opioid addiction,” wrote Stewart Abe. “Kratom not only helps me get over that addiction, but it also helps me deal with the pain so I can be a functioning member of society. Without this plant in my life, the pain would be so horrific that it would not be worth living.”

“Kratom has helped countless people get away from addictive opioids and alcohol. It has all but saved my life from alcoholism and I haven’t drank in 8 years now,” wrote Davis Matthew. “Kratom has completely turned my life around and without it who knows how my life would have turned out.”

The legal status of kratom in Southeast Asia is mixed. In August, Thailand decriminalized kratom, dropped thousands of pending criminal cases involving the drug, and freed 121 inmates convicted of kratom crimes.

Hong Kong authorities recently banned kratom and seized a shipment of 2.5 tons of kratom powder that were enroute to Florida from Indonesia. Kratom use is banned domestically in Indonesia, but kratom farming is still permitted. Most kratom exports come from Indonesia, where it is considered an important cash crop.

Is Kratom Right for You?

By Forest Tennant, PNN Columnist

The answer to the headline on this column depends upon whether you can get enough prescription opioids to control Intractable Pain Syndrome (IPS).

In many locales in the country, doctors — for multiple reasons — will not prescribe enough opioids to control IPS and its cardiovascular, endocrine and autoimmune manifestations. If you can’t get enough prescription opioids to keep your pain under control, you should give kratom a try.

What Is Kratom?  

Kratom is a compound found in the tree leaves of the mitragyna speciosa plant that grows in southeast Asia.

It is an herb and not an opioid, but it produces pain relief like an opioid. Biologically, it attaches to the opioid receptors (pain relief sites) in the brain and spinal cord, and relieves pain just like an opioid. 

Kratom is legal in most of the United States and is widely advertised and promoted on the Internet. It is available as a pill, capsule or powdered extract.

It can be used by itself for pain relief or taken simultaneously with a prescription opioid. Most persons with IPS who report kratom use take it between opioid dosages or use it just for flares.

How Do I Know How Much to Take? 

There are several formulations and many brands of kratom. In fact, we have received so many different reports that we can’t really say that one form, color or source is better than another. Our recommendation is that you acquaint yourself with someone who already takes kratom for pain relief. This person is in the best position to “show you the ropes” relative to dosage, types and sources. 

As with any new drug, start at a low dose and work up over time to maximize its effectiveness and prevent any severe side effects. Kratom is available without a prescription, but check with your state laws first. It is currently illegal in a few states and some communities.

Do not let today’s opioid restrictions ruin your health and life by leaving you in severe pain. Kratom may be just right for you. 

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.    

Thailand Decriminalizes Kratom as WHO Considers Banning It

By Pat Anson, PNN Editor

For the first time since World War II, it is legal again in Thailand to grow and sell kratom, a tropical tree used for centuries in Southeast Asia as a natural stimulant and pain reliever. In 1943, the military junta that ruled Thailand banned the planting of kratom trees because the popularity of kratom in rural areas was interfering with tax revenue from the opium trade.  

Ironically, the decriminalization of kratom in Thailand comes as the World Health Organization (WHO) considers placing international restrictions on kratom and six other psychoactive substances.

With kratom no longer listed as a narcotic in Thailand, thousands of pending criminal cases involving kratom are being dismissed and 121 inmates convicted of kratom crimes will be released from prison. Possession of kratom had been punishable by up to two years in prison.

In recent years, Thailand has been liberalizing many of its drug laws to ease pressure on its justice system. There was also growing recognition that kratom could become an important cash crop for Thai farmers. The global trade in kratom has grown significantly in recent years, with millions of Americans using kratom to self-treat their pain, anxiety, depression and addiction. Most kratom exports currently come from Indonesia.

It remains illegal in Thailand to mix kratom with other drugs. Some recreational users boil the leaves and mix it with codeine cough syrup, creating a “kratom cocktail.”

"To decriminalise kratom is the right thing to do. Local people or patients who need it will be able to access it more easily. However, I am concerned that teenagers will use it in a wrong way, for example, mixing kratom with other narcotics. We have to control this strictly, otherwise, it can cause damage," Ramdin Areeabdulsorma, a Thai politician, told the Associated Press.

‘Kratom Saved Me’

Under international treaties, WHO is required to assess the use of psychoactive substances and advise the United Nations on whether they pose a public health risk. WHO’s annual assessment will begin in October and U.N. members have been asked to submit their recommendations.

Kratom is legal in most U.S. states, although some states and communities have banned it. The Food and Drug Administration has tried -- unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

Today is the last day for people to submit comments on the Federal Register for the FDA to consider as it prepares its response to WHO. Over 8,500 comments have been received so far, the vast majority asking the FDA and WHO not to ban kratom.  

“Kratom saved me from a lifetime opiate addiction. At 45 years old, I was unemployable and on my way to prison or death. Methadone or Suboxone hadn't kept me clean,” wrote Cecelia Lore. “I have never abused (kratom) as I hear some do. It has never caused a disruption in my life. I honestly feel that you should be looking at soda and junk food as the real dangers to our communities.”

“Kratom has helped both my wife and I stop taking opioids altogether. We never experienced withdrawals and we continue to use kratom rather than any other pain reliever because of its cost, lack of addictive nature and overall effectiveness. Rather than any kind of ban, what we need is regulation of the quality of the products,” said Nick Simpson.

“Kratom has made a direct impact on my life by helping me quit a debilitating alcohol addiction. I was an alcoholic for 6 years and to the point of being hospitalized several times with seizures from withdrawals,” wrote Tyler Davis.  “(Banning kratom) would harm a very large number of people recovering from addiction and force many back to destructive lifestyles.”

The American Kratom Association, a group of kratom vendors and consumers, has claimed the FDA instigated WHO’s review of kratom as a way to bypass the drug scheduling process in the U.S. An FDA spokesperson denied that, telling PNN the agency “does not determine for the U.S. government which substances shall be proposed” for WHO to review.

FDA Seeking Public Comments on Kratom

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is seeking public comments on the medical use and abuse of kratom. In a notice published Friday in the Federal Register, the FDA said the comments will be reviewed as it prepares a response to the World Health Organization (WHO), which is considering whether to place international restrictions on kratom and six other psychoactive substances.   

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat pain, anxiety, depression and addiction. The FDA has tried -- unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

Under international treaties, WHO is required to assess the use of psychoactive substances and advise the United Nations on whether they pose a public health risk and should be controlled. The annual assessment will begin in October and U.N. members have been invited to submit their recommendations.

Although the FDA said the U.S. will defer from making any immediate recommendations to WHO, the notice in the Federal Register makes plain that the agency still has a dim view of kratom. It makes no mention of the medical benefits many kratom users get from the herbal supplement.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms.”

— FDA

“Kratom is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States. Evidence suggests that kratom is abused individually and with other psychoactive substances,” the FDA said.

“Kratom has a history of being used as an opium substitute in Southeast Asia. In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom has been reported to have both narcotic and stimulant-like effects.”

The American Kratom Association (AKA), a group of kratom vendors and consumers, said FDA instigated WHO’s review of kratom as a way to bypass the drug scheduling process in the U.S. The AKA is urging kratom consumers to submit positive comments about the herbal supplement.  

“The comments should be focused on the experiences that kratom consumers have had with kratom and how it has benefited them in terms of improving their quality of life, to reduce pain, to reduce anxiety and depression, to wean off of opioids, and how kratom has saved their lives,” Mac Haddow, an AKA lobbyist, said in a video. “We want the WHO to know the powerful experiences that people have had. We want to protect kratom, not only here in the United States, but also around the world.”

There’s an August 9 deadline for comments, which can be submitted here.

Asked if the FDA requested WHO to review kratom, a spokesperson told PNN the agency “does not determine for the U.S. government which substances shall be proposed” for review. WHO reviews can be requested by any member countries that are signatories to international drug control treaties.

Kratom’s legal status varies around the world. Thailand recently decriminalized kratom and will make the plants legal to grow and export in August. Kratom use is banned domestically in Indonesia, but kratom farming is still permitted. Most kratom exports come from Indonesia, where it is considered an important cash crop.

Kratom sales are legal in most U.S. states, although some states and communities have banned it. The FDA recently seized 37 tons of kratom from a vendor in Florida for alleged violations of a federal law that prohibits the sale of adulterated dietary supplements.

A federal effort in 2016 to ban kratom nationwide failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew a request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat. A top HHS official later said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

OHSU Researchers Find ‘No Evidence’ to Support Use of Kratom

By Pat Anson, PNN Editor

A federally funded review of plant-based treatments for chronic pain has yet to find adequate clinical evidence on the benefits or harms of kratom, an herbal supplement used by millions of Americans to relieve pain, anxiety, depression and other medical conditions.

In an update released this week, researchers at Oregon Health & Science University (OHSU) reported that some cannabis products provide small to moderate pain relief, a finding based on a systematic review of two dozen clinical trials of cannabis.  But no similar studies were found to support the use of kratom or any other plant.   

“No evidence on other plant-based compounds, such as kratom, met criteria for this review,” researchers said.

OHSU was awarded a contract last year by the Agency for Healthcare Research and Quality (AHRQ) to review the evidence for cannabis, kratom and other plant based treatments for chronic pain.  

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia. Although it has been used for centuries as a natural stimulant and pain reliever, few clinical trials have been conducted to test kratom’s efficacy or safety. The few studies that have been conducted were excluded by OHSU researchers due to their size, methodology or because they weren’t published in English.

For example, a 2020 Malaysian study that found kratom provided “a substantial and statistically significant increase in pain tolerance” was excluded because the young men who participated in the one-day trial were considered an “ineligible population.” OHSU researchers excluded all studies lasting less than 4 weeks.

“The conclusion that there is no evidence to support the effects of kratom on chronic pain is absurd.”

— Mac Haddow, American Kratom Association

“Setting aside the disappointment that AHRQ does not appear to be taking the purpose of the review of plant-based compounds very seriously, the conclusion that there is no evidence to support the effects of kratom on chronic pain is absurd,” said Mac Haddow, a lobbyist for the American Kratom Association.  “It’s like denying that Chicago is a windy city because the instrument that was selected for assessing wind speed was not used.”

Haddow said the AHRQ review should be expanded to include survey results from kratom users, animal studies and other types of research that don’t rise to the level of a clinical trial.

“The review appears to be excluding any research that is not a pharmaceutical development clinical trial model that would involve controlled kratom administration in a full-blown human clinical trial,” Haddow told PNN. “The deeply embedded bias against plant-based compounds that offer potential values for addressing the opioid crisis — or even providing a non-addictive and safer alternative for the management of acute and chronic pain should be a priority for the AHRQ.”

This isn’t the first time the quality of federal research into the safety and efficacy of kratom has been questioned. In 2018, the Department of Health & Human Services quietly withdrew an FDA request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. A former HHS official recently said the FDA’s recommendation was rejected because of “embarrassingly poor evidence & data.”

$2 Billion in Federal Grants

A final report on plant-based treatments for chronic pain is expected in August. As PNN has reported, OHSU researchers have recently conducted a series of reviews on a wide variety of pain therapies for the AHRQ, which are being used by the Centers for Disease Control and Prevention to revise and possible expand its controversial 2016 opioid guideline.   

Much of that research is being led by Dr. Roger Chou, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at OHSU.  Chou, who co-authored the CDC opioid guideline, is a prolific researcher who has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to reduce the use of opioid medication.

The contract on plant-based pain treatments is potentially worth up to $1.4 million for OHSU, a public research university that the federal government often turns to for medical research. According to the website GovTribe, in the last five years OHSU has been awarded nearly $2 billion in federal research grants to study everything from cancer and contraceptives to Alzheimer’s and Parkinson’s Disease.

OHSU paid $1.3 million back to the government to settle allegations that it misused grant money in its primate research center. Although the settlement was reached in 2018, it was not made public until recently in an Inspector General’s report, according the animal rights group Rise for Animals.

FDA Seizes 37 Tons of Kratom in Florida

By Pat Anson, PNN Editor

The Food and Drug Administration has announced a large seizure of kratom from a supplement packaging company in Florida, in what could be an escalation of the agency’s efforts to stop kratom sales in the United States.

Over 37 tons of kratom powder and over 200,000 units of dietary supplements containing kratom were seized earlier this month by U.S. Marshals at an Atofill warehouse in Fort Myers, FL. The company imports kratom from Indonesia and resells it in capsules and powder under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical and El Diablo. The seized products are worth about $1.3 million, according to the FDA.

In April, Atofil and dozens of other kratom exporters and importers were named by the FDA in an updated import alert which gives the agency broad powers to seize shipments of kratom. In a statement on Twitter, acting FDA Commissioner Janet Woodcock, MD, compared kratom to morphine.

“To protect the public health, the FDA will continue to take action against kratom-containing dietary supplements,” Woodocok said. “Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Kratom affects the same opioid brain receptors as morphine & appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence.”

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. A recent study estimated that about two million Americans use kratom to self-treat their chronic pain, anxiety, depression and addiction.

Kratom is sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions or market it as a dietary supplement. During an FDA inspection of Atofil earlier this year, investigators observed large quantities of kratom powder and capsules labeled as “herbal supplements.” In the eyes of the FDA, that is a violation of federal law that prohibits the sale of adulterated dietary supplements.

The U.S. Department of Justice, working on behalf of the FDA, filed a civil complaint against Atofil in federal court, alleging that kratom is a new dietary ingredient for which there is no adequate information on its potential risk to human health.

Mac Haddow, a lobbyist for the American Kratom Association, told PNN the court action and seizure amounted to “an end-around of the Controlled Substances Act” by the FDA and was “a pretty big expansion of their authority.”

‘Embarrassingly Poor Evidence’

A DEA effort to ban kratom in 2016 failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew its request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat.

Former FDA Commissioner Scott Gottlieb, MD, who regularly campaigned against kratom while heading the agency, says more action needs to be taken by the Biden administration.

“We were prevented by HHS from moving forward with the scheduling of Kratom, and I’m convinced it’s fueling the opioid addiction crisis. The Biden Administration should follow through on efforts of FDA, NIH, and DEA — and the new ASH should affirm health findings of these agencies,” Gottlieb said on Twitter, referring to Rachel Levine, MD, Asst. Secretary for Health at HHS.

Gottlieb’s tweet brought a rebuke from Brett Giroir, MD, a former four-star admiral in the U.S. Public Health Service and Asst. Secretary for Health in the Trump administration. It was Girior who wrote a 2018 letter to the DEA notifying the agency that HHS was withdrawing its request to schedule kratom.

“FDA doesn't schedule; it only recommends. FDA's recommendation was rejected b/c of embarrassingly poor evidence & data, and a failure to consider overall public health. If #Kratom is fueling opioid addiction, prove it; and then @HHS_ASH should reconsider,” Giroir tweeted.

Gottlieb responded with yet another tweet, claiming that “public health suffered” as a result of Girior’s action.

“It’s true: Brett Giroir unilaterally overruled a considered, multi year, scientific effort by the NIH, FDA, and DEA and a careful analysis in an act I found hasty and ill conceived,” said Gottlieb.

A 2020 study funded by the National Institute on Drug Abuse — which is part of the the NIH — concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

Study Estimates Two Million Americans Use Kratom

By Pat Anson, PNN Editor

A new study estimates that less than one percent of Americans -- about two million people --- use kratom, an herbal supplement that’s growing in popularity as a treatment for pain, depression, anxiety and addiction.

The study, one of the first to look at kratom use in the general population, is based on data from the 2019 National Survey on Drug Use and Health – the first year the annual survey asked respondents about kratom.

Researchers at New York University’s Grossman School of Medicine looked at data from over 56,000 people who participated in the survey and estimated that 0.7 percent of adults and adolescents in the U.S. used kratom in the past year.

Kratom use was more likely by people who also use cannabis, stimulants and cocaine, and was particularly common among those who misuse prescription opioids. About 10 percent of people diagnosed with opioid use disorder reported kratom use.

“It was not surprising at all that such a large portion of people with opioid use disorder use kratom. What I didn’t expect was to find kratom use to be independently linked to cannabis use disorder,” said study author Joseph Palamar, PhD, an associate professor of population health at NYU Grossman School of Medicine.

“A lot of people who use substances to get high also use other substances to get high — alone or in combination. If anything, I hope that results of this paper demonstrate not only that a lot of people with opioid use disorder use kratom, but also a lot of people who use other drugs have been adding this substance to their drug repertoires for whatever reason.”

Men, white people, and those with depression and serious mental illness were also more likely to report using kratom. Teenagers and adults over 50 were less likely to use it.

The findings are similar to those in a 2016 PNN survey of over 6,000 kratom users. A little over half said they primarily used kratom for pain relief, while others used it as a treatment for anxiety (14%), opioid withdrawal (9%), depression (9%) and alcoholism (3%).  Over 90% said kratom was “very effective” in treating their medical condition.   

“A lot of people who use kratom rave about its ability to decrease opioid withdrawal, but kratom itself can be addicting so people need to be aware and be careful. Kratom might indeed be able to serve as a useful tool for people seeking to get off opioids, but I think more research is needed to determine exactly how it should be used and how to use it safely,” Palamar said in an email to PNN.

The study, published in the American Journal of Preventive Medicine, notes that over 150 overdose deaths linked to kratom have been reported. But most of those overdoses also involved other drugs such as illicit fentanyl, heroin and cocaine, or prescription drugs such as benzodiazepines and psychiatric medications.    

“Given the high number of poisonings involving kratom combined with other drugs, I hope that at least people who decide to use it try to avoid combining it with other substances,” Palamar said.

Kratom comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions. The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

The American Kratom Association, an advocacy group for kratom consumers and vendors, claims that 10 to 16 million Americans use kratom. That estimate is based on exports to the U.S. reported by kratom growers in Indonesia.