As the opioid epidemic continues raging, some advocates in Kentucky are pushing the state to explore a little-known psychedelic drug called ibogaine as a possible treatment option for addiction, a move, they say, could save lives.
A state committee is considering funding research into the drug, marking the first time a state has looked into such an approach and underscoring the urgent need to expand the playbook to combat a crisis that has devastated the region in the past decade.
The psychedelic is derived from the iboga plant, a shrub native to parts of Central Africa. Ibogaine is classified as a Schedule I drug in the U.S., but is unregulated in many other countries, including Mexico, where it has grown in popularity as a treatment for opioid use disorder. It’s also attracted controversy: given without proper medical supervision, the drug can be risky — even deadly. And it’s not a silver bullet to end addiction.
The compounds in ibogaine have shown promise for treating addiction, particularly to opioids, but better research is needed to determine how it works, said Genís Oña, a researcher coordinator at the International Center for Ethnobotanical Education, Research and Service in Spain who studies ibogaine.
The Kentucky Opioid Abatement Advisory Commission plans to vote on whether to allow the state to start funding that research. The move would allocate $42 million — taken from the nearly $840 million it received from opioid lawsuit settlements with pharmacies, drugmakers and drug distributors — to study ibogaine therapy.
Studying the substance in the U.S. would allow researchers to better understand its safety and efficacy at a time when new therapies for addiction are badly needed. In 2020, yearly drug overdose deaths surpassed 100,000 for the first time. Opioids played a role in 75% of those deaths.
Kentucky is tied with Tennessee for the second-highest drug overdose death rate in the country — 55.6 per 1,000 deaths — the most recent data from the Centers for Disease Control and Prevention shows. Only West Virginia has a higher mortality rate from drug overdoses, at more than 90 per 1,000. The region has been the hardest-hit in the country since 2010.
Bryan Hubbard, the chair and executive director of the Kentucky Opioid Abatement Advisory Commission, came across ibogaine when he was exploring therapies that might work better than opioid replacement therapies, including methadone, buprenorphine and naltrexone, which are considered the leading treatments.
“They have about a 25% success rate, and that is a success rate that is exceptionally mediocre. Ibogaine could be an opportunity for a significant breakthrough,” Hubbard said. He took the idea to Kentucky Attorney General Daniel Cameron, who greenlighted the commission’s request to explore the possibility of ibogaine research.
In September, the commission heard testimony from dozens of addiction and psychedelics experts and political figures in favor of the therapy, as well as people who have used ibogaine. The group is waiting on additional testimony before it schedules the vote on funding, Hubbard said.
“What’s happening in Kentucky is really important,” said Alan Davis, the director of the Center for Psychedelic Drug Research and Education at Ohio State University. If the commission votes in favor of funding, “that will single-handedly be the absolute biggest amount of resources into funding anything related to psychedelic research, let alone for ibogaine, and it should be done. It should be explored scientifically.”
A window of opportunity to get clean
The idea of using psychedelics to help people with substance use disorders is not new.
Research published last year found that psilocybin, the hallucinogenic compound found in magic mushrooms, helped alcoholics reduce their drinking. This year, the National Institutes of Health granted funding to Johns Hopkins University scientists to study whether the same drug could help smokers quit.
The thinking goes that psychedelic trips, conducted in clinical settings with therapists to guide patients, could help patients process information in a different way to arrive at conclusions that help them get sober.
A powerful trip on ibogaine is what shook Bobby Laughlin, of Playa Vista, California, from his dependence on opioids.
Laughlin, 34, had been using the drugs since college, starting with prescription pills and quickly progressing to heroin. In a last-ditch effort to get clean, he flew to Mexico with $8,000 in cash to try ibogaine therapy.
“That seemed like a Hail Mary,” he said.
The single trip was potent, and it threw Laughlin into “the equivalent of hell,” he remembered. He said he felt like he could barely move and he hallucinated for hours, an experience that went from terrifying to enlightening. When it was over, he said, he was completely changed. “I knew that I had a window of opportunity to restructure my life,” said Laughlin, who has been sober for more than a decade.
“After having been so far removed from yourself, it’s like getting to know an old friend,” he added, through tears, of being sober. “Especially if it’s a friend that you may not, you know, it’s like I never knew that I would see him again.”
Anecdotal evidence and research conducted outside the U.S. have shown ibogaine appears to have a unique ability to help people with opioid use disorder.
“With psychedelic treatments, the focus is on the emotional issues that underlie the establishment of the addiction,” said Oña, the researcher from Spain. “In the case of ibogaine, we have a combination of these potential psychological insights, plus the anti-addictive, physical effect.”
Early research, he said, has suggested the compound works differently from other psychedelics, actively suppressing withdrawal and creating a window of opportunity for people to get clean.
In a meta-analysis published in November in the Journal of Psychopharmacology, Oña and others determined that ibogaine acts on several pathways in the body associated with substance use disorder. That is most likely what gives ibogaine the unique ability to relieve symptoms of withdrawal, which experts believe is one reason the compound has been found to be a powerful therapy for opioid use disorder.
“Even in low doses, ibogaine seems to be interrupting withdrawal syndrome,” Oña said, adding that it’s still unclear exactly how. Treatments typically have a target, such as opioid receptors in the brain, that they either block or stimulate to effectively treat addiction. But ibogaine seems to have an effect on multiple targets throughout the body, including in the brain, and researchers are still determining how ibogaine appears to both produce a trip and give people who take the psychedelic relief from withdrawal symptoms.
“Currently we only have observational data supporting the use of ibogaine for addictive disorders,” Oña said. “We have a lot of case reports and population studies of people who have undergone some treatments in formal settings, such as clinics in Mexico and other countries, but right now there is low reliability data.”
Oña is part of a group conducting the world’s first double-blind phase 2 clinical trial on ibogaine for opioid dependence. The trial began in 2020, and the results are expected to be published by early next year.
To eventually seek Food and Drug Administration approval, clinical trials will need to demonstrate the benefits outweigh the risks, said Dr. Srinivas Rao, the chief scientific officer at Atai Life Sciences, a biopharmaceutical company that is doing its own research on ibogaine for opioid use disorder. Right now, most studies of ibogaine and opioid use disorder are limited to observational evidence.
“The gold standard is a double-blind, placebo-controlled study, and that doesn’t exist for this compound,” Rao said.
Risks and setbacks
Ibogaine has known safety risks, which, while rare when it is used in a controlled setting with trained health care professionals, can be severe.
It can be toxic to the kidneys and liver, and observational studies have concluded it can cause irregular heart rhythms that can lead to cardiac arrest. It's also been shown to act as a stimulant.
The health risks are amplified because ibogaine clinics operate largely without regulation and standard medical care — such as monitoring heart rate and testing patients for drugs that might interact dangerously with ibogaine — that protect the safety of patients who take it.
Allowing the drug to be used in more controlled settings could decrease its risks.
“When it’s not properly done, there is a risk of death,” said Davis, of Ohio State University. “We need to be able to test it in a safe environment, to be able to screen people safely and make sure that people who are at risk for those complications aren’t given the medicine.”
Oña said monitoring people’s hearts with EKG machines for at least 24 hours after they take ibogaine should be practiced in human trials. Patients should also not be allowed to leave the hospital during that window, because if they leave and use, the drugs would interact badly with ibogaine, he said. Ensuring the purity of the ibogaine is also important, as is having patients work with psychologists during the experience.
Ibogaine is also not a panacea.
Kevin Franciotti, of Littleton, Colorado, said he was “totally addicted” to oxycodone by the time he was ready to graduate from college.
The following years were a revolving door of attending treatment programs only to use again once he got out. He was arrested and started using heroin. One day, when his mother confronted him about what was going on, he blurted out: “I’ve been using. I don’t know how to stop. I don’t think rehab is going to work. Why don’t we try ibogaine?” he said.
In July 2011, Franciotti found an ibogaine clinic in Mexico and arranged to meet someone from the clinic in San Diego and drive across the border.
His trip was profound, and it allowed Franciotti to realize he could live without drugs controlling his life.
But when he came down, he was flooded with feelings of shame and guilt.
“If it wasn’t for the fact that I was stuck in this clinic setting in a foreign country, I probably would have left to score if I had not been supervised,” he said.
When he left the clinic, he immediately checked into a live-in recovery program. Today, Franciotti, 37, who works as an addiction counselor, emphasized that ibogaine by itself is not a silver bullet.
“I don’t know anyone who could just take ibogaine and totally be fine,” he said.
It’s paramount that people have stable social support — being around friends, family and work environments that do not encourage them to start using again — and some kind of ongoing aftercare, whether that be a 12-step program or therapy, he added.
But patients who seek psychedelic therapy risk losing the supportive social structures they may otherwise rely on — no therapy is perfect.
“It’s still very stigmatized, and where it isn’t stigmatized, it’s still very misunderstood how this works,” he said. “People in 12-step programs can risk losing their social support by seeking psychedelic treatment.”
If Kentucky votes to fund research on ibogaine, the FDA will still need to give special permission for any research moving forward.
Hubbard said the process would look similar to the one the NIH uses to fund research. Research teams would submit proposals to the commission that outline how they would partner with Kentucky hospitals to conduct ibogaine trials. It’s unclear whether existing evidence about safety and efficacy would be enough to allow clinical trials in patients in Kentucky to begin right away. If not, researchers may need to begin with nonhuman studies, Hubbard said.
From there, the commission will choose the research plans that have the best shots at winning FDA approval. Because ibogaine is a Schedule I drug in the U.S., the research will need special permission from the FDA through a process called an Investigational New Drug, or IND, application.
“When the FDA has approved the IND application and cleared the clinical trial plans and the research partner has partnered with hospitals in Kentucky to conduct the clinical trials, only then would the commission release the funds,” Hubbard said.
If an application is approved, researchers would also need to work with the Drug Enforcement Administration to secure ibogaine for research. Hubbard estimates that if all goes according to plan, trials could be completed within four to six years — but it’s important that ibogaine clinical trials take extra precautions not present in other psychedelic research, because ibogaine poses unique cardiac risks.
“It is of the utmost importance that any ibogaine studies in Kentucky occur in a controlled medical setting where there is proper screening and medical monitoring that can make the research of ibogaine eminently safe to administer,” he said.
CORRECTION (Dec. 14, 2023, 6:20 p.m. ET): A previous version of this article misstated ibogaine’s effects on the heart. It can cause irregular heart rhythms, not a sped-up heart rate.