Oct 5 (Reuters) – US health officials are advancing the first government-funded clinical trials of the psychedelic drug ibogaine to treat opioid addiction and post-traumatic stress disorder, the FDA said on Monday, as it sought public feedback on safety rules for the studies.
The initiative follows an April executive order by President Donald Trump dedicating $50 million to federal ibogaine research, as well as recent calls by experts and veterans for strict safety standards on psychedelic treatments.
The Department of Health and Human Services is funding early-stage trials through the Advanced Research Projects Agency for Health and the National Institute on Drug Abuse.
Ibogaine, a compound found in the roots of the African shrub iboga, is classified as an illegal Schedule I controlled substance under US law. However, it has gained attention from military veterans who have traveled abroad seeking relief from trauma and addiction.
“Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches,” said Michael Davis, director of the FDA’s Center for Drug Evaluation and Research. Davis said the agency will prioritize patient safety.
The Food and Drug Administration has warned that the drug carries severe health risks, including life-threatening irregular heart rhythms and potential brain toxicity.
The regulator has opened a public docket seeking feedback on trial design, dose selection, patient eligibility, safety monitoring, study-stopping rules and oversight by November 20. The information could help inform future reviews of applications to test ibogaine in humans.
Under initial trial approaches outlined by the FDA, participants would receive single, gradual doses capped at 10 milligrams per kilogram and remain under continuous hospital heart monitoring for up to 36 hours.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Sahal Muhammed)
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