Drug company Atai Life Sciences is spending millions to research the compound, and congressional lawmakers from both parties have pushed the administration to advance research into ibogaine for substance abuse, post-traumatic stress disorder and other mental health problems.
For Dr. Deborah Mash, a professor of neurology at the University of Miami who began studying ibogaine in the early 1990s, the growing interest is a vindication of her belief that the compound could help ameliorate the opioid crisis. “Ibogaine is not a silver bullet and it won’t work for everyone, but it is the most powerful addiction breaker I’ve ever seen,” he said.
Researchers have also studied ibogaine’s ability to treat other difficult mental health problems. A small study published earlier this year in the journal Nature Medicine found that military veterans with traumatic brain injuries who underwent a single session of ibogaine treatment experienced marked improvements in disability, psychiatric symptoms and cognitive function.
No adverse effects were reported in the 30 study participants, who were followed for one month. There was no control group.
Dr Nolan Williams, lead author of the study, said the results were particularly remarkable given the lack of treatment options for traumatic brain injuries.
“These are the most dramatic drug effects I’ve ever documented in an observational study,” said Dr. Williams, who is director of the Brain Stimulation Laboratory at Stanford University.
He and other researchers are quick to recognize the limitations of the existing science on ibogaine therapy. “Without a green light to conduct studies from the FDA, you simply cannot do the kind of randomized trials that are the gold standard for clinical trials,” Dr. Williams said.
Ibogaine is known to cause arrhythmia, or an irregular heartbeat, which in severe cases can lead to fatal cardiac arrest.
Other researchers are more skeptical of its potential as a widely accessible addiction treatment. William Stoops, a University of Kentucky behavioral science professor who specializes in substance use disorders, said ibogaine’s heart risks make it a poor candidate for regulatory consideration.
Even if ibogaine were to receive FDA approval, the failing health of many long-term opioid users, many of whom have cardiovascular problems, would make them ineligible for treatment, Dr. Stoops said. And the high cost of providing ibogaine in a medically supervised setting would further reduce the pool of potential patients, he added. “Access would be so limited that how many people could benefit?” asked.
The National Institute on Drug Abuse, part of the National Institutes of Health, has already begun funding studies (not human trials) of ibogaine analogs, chemically related compounds that may provide therapeutic benefits without health risks. The agency’s director, Dr. Nora Volkow, said she has long been intrigued by ibogaine’s anti-addictive potential — and wary of its heart risks.
However, existing opioid use disorder treatments, such as methadone and buprenorphine, are imperfect, he noted, and half of patients stop taking them after six months.
“In addition to existing effective drugs, there is a need for treatment options that are different than what we have today,” said Dr. Volkow. “We need to break the way we’ve been doing things and explore what the science is showing us.”
The FDA said it could not comment on whether it would support ibogaine studies in the future, noting that federal law prohibits the agency from commenting on potential research drug applications.
