U.S. health officials are moving toward the first government-funded clinical trials of ibogaine, a powerful psychedelic drug being investigated as a potential treatment for opioid addiction and post-traumatic stress disorder.
The Food and Drug Administration (FDA) announced Monday that it is seeking public input on how early-stage ibogaine trials should be designed, including dosage, patient eligibility, safety monitoring and rules for stopping a study if serious problems emerge. The public comment period runs through Nov. 20.
The Department of Health and Human Services is supporting early-stage research through the Advanced Research Projects Agency for Health and the National Institute on Drug Abuse. Federal officials have identified adults with opioid-use disorder and adults with PTSD as the first populations being prioritized for federally supported ibogaine research.
Ibogaine is a naturally occurring psychoactive compound found in the African iboga shrub. Interest in the drug has grown because some researchers and patients have reported reductions in opioid withdrawal, cravings and symptoms associated with trauma. But the scientific evidence remains limited, and ibogaine carries potentially serious risks, particularly dangerous changes in heart rhythm.
Those safety concerns will be central to the federal research. One NIDA-funded project calls for an initial study in healthy volunteers to determine a tolerable dose before researchers move toward testing ibogaine in people with opioid-use disorder who have not responded adequately to buprenorphine treatment. Ibogaine remains a Schedule I controlled substance in the United States and is not an FDA-approved treatment for opioid addiction or PTSD.
The Readovia Lens
The significance of the federal trials isn’t that ibogaine has been proven to work—it hasn’t. The shift is that a controversial psychedelic long pushed to the edges of American medicine is moving into tightly controlled government-supported research, where scientists can begin answering the two questions that matter most: whether it works and whether it can be used safely.
