FDA proposes ibogaine trial design, seeks input

FDA proposes ibogaine trial design

The U.S. Food and Drug Administration (FDA) has proposed a design for early-stage clinical trials of ibogaine, a psychoactive substance under investigation for therapeutic use. This proposal was made public on the final day of the FDA's comment period for its guidance on psychedelic drugs, according to Psychedelic Alpha.

Key elements of the proposed trial

The FDA's suggested trial design includes several specific elements. Participants would be enrolled in sequential dose ascending groups, with a maximum dose of 10 mg/kg. Dosing would occur individually, with potential increases between cohorts subject to review by safety committees and the FDA. The trials would be conducted in inpatient units equipped for cardiac emergencies, with continuous cardiac monitoring until normal rhythms are restored, potentially up to 36 hours post-dose.

Participants might be genotyped for CYP2D6, with only fast and intermediate metabolizers included, and doses adjusted as necessary. Certain medications, such as opioid agonists and SSRIs, would be discontinued. The design also includes strict stopping rules and cognitive testing over a 12-month period.

Regulatory context

This request for information (RFI) is part of a broader initiative by the U.S. Department of Health and Human Services to coordinate ibogaine research. Federal bodies like the National Institute on Drug Abuse (NIDA) and the Advanced Research Projects Agency for Health (ARPA-H) are involved in this effort.

Why it matters

The FDA's proposal and request for input mark a significant step in the potential therapeutic use of ibogaine. By outlining a trial design and seeking public feedback, the FDA aims to refine protocols that could pave the way for future clinical investigations. This initiative reflects a growing interest in the therapeutic potential of psychedelics for treating conditions like opioid use disorder and PTSD.

The FDA's engagement with the public and scientific community underscores the importance of collaborative efforts in advancing psychedelic research.