By THE NEW YORK TIMES
The drug company Atai Life Sciences is spending millions to research the compound, and congressional lawmakers from both parties have been pushing the government to promote ibogaine research 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 soaring 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 everybody, but it’s the most powerful addiction interrupter I’ve 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 ibogaine therapy session experienced marked improvements in disability, psychiatric symptoms and cognition.
No adverse side effects were reported among the study’s 30 participants, who were followed for a month. There was no control group.
Dr. Nolan Williams, the study’s lead author, said the results were especially notable given the lack of therapeutic options for traumatic brain injuries.
“These are the most dramatic drug effects I’ve ever captured in an observational study,” said Dr. Williams, who is the director of the Brain Stimulation Lab at Stanford University.
He and other researchers are quick to acknowledge the limitations of existing science on ibogaine therapy. “Without a greenlight to conduct studies from the F.D.A., you just can’t do the kind of randomized trials that are the gold standard for clinical studies,” Dr. Williams said.
Ibogaine is known to induce 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 broadly accessible anti-addiction therapy. William Stoops, a professor of behavioral science 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 were to receive approval from the Food and Drug Administration, the tattered 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 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 (that are not trials involving humans) on ibogaine analogues, chemically related compounds that might provide the therapeutic benefits without the 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, like methadone and buprenorphine, are imperfect, she noted, and half of all patients stop taking them after six months
“In addition to existing effective medications, there is a need for treatment options that are different from the ones we currently have,” Dr. Volkow said. “We need to break the way we have been doing things and explore what the science is showing us.”
The F.D.A. 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 prospective investigational drug applications.
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