by The pharmaceutical company Atai Life Sciences is spending millions to research the compound, and congressional lawmakers from both parties have been pressuring the government to promote research into ibogaine for substance abuse, post-traumatic stress disorder and other health problems. mental health.
For Dr. Deborah Mash, a neurology professor 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 have ever seen,” she said.
Researchers have also been studying 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 therapy experienced marked improvements in disability, psychiatric symptoms, and cognition.
No adverse side effects were reported among 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 especially notable given the lack of therapeutic options for traumatic brain injuries.
“These are the most dramatic drug effects I have ever captured in an observational study,” said Dr. Williams, 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 the green light to conduct studies from the FDA, you simply cannot conduct the type of randomized trials that are the gold standard for clinical studies,” Dr. Williams said.
Ibogaine is known to induce arrhythmia, or irregular heartbeat, which in severe cases can lead to fatal cardiac arrest.
Other researchers are more skeptical about its potential as a widely accessible anti-addiction therapy. William Stoops, a professor of behavioral sciences at the University of Kentucky who specializes in substance use disorders, said ibogaine’s cardiac risks made it a poor candidate for regulatory consideration.
Even if ibogaine received approval from the Food and Drug Administration, the deteriorating 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 narrow the pool of potential patients, he added. “Access would be so restricted that how many people could benefit?” he asked.
The National Institute on Drug Abuse, part of the National Institutes of Health, has already begun funding studies (not human trials) on ibogaine analogs, chemically related compounds that could provide therapeutic benefits without health risks. . The agency’s director, Dr. Nora Volkow, said she had long been intrigued by ibogaine’s anti-addiction potential and wary of its cardiac risks.
But existing treatments for opioid use disorder, such as methadone and buprenorphine, are imperfect, he noted, and half of all patients stop taking them after six months.
“In addition to existing effective medications, treatment options other than what we currently have are needed,” Dr. Volkow said. “We need to break away from the way we have been doing things and explore what the science shows us.”
The FDA said it could not comment on whether it would support studies with ibogaine in the future, noting that federal law prohibits the agency from commenting on potential investigational drug applications.
