Pα+ Psychedelic Bulletin #233: FDA Floats Ibogaine Trial Design; Compass Talks Pricing; Potential LSD, Psilocybin Brand Names

FDA Floats Ibogaine Trial Design, Asks Field for Input

On Monday, the day FDA’s Considerations for Potential Future Therapeutic Use of Psychedelic Drugs public comment period closed, the agency issued a request for information (RFI) related to clinical studies of ibogaine.

In the notice, FDA outlines a potential early-stage ibogaine clinical trial design, which it says is consistent with its final guidance for clinical investigations of psychedelics, published in July.

Key trial design elements that the agency offers up for said hypothetical study include:

• Participants would be enrolled in “sequential dose ascending groups”, with a cap of 10 mg/kg
• Participants would be dosed one at a time, with potential dose increases from cohort to cohort to be considered “after appropriate review”, which could include a safety review committee, a data and safety monitoring board, and the FDA
• Dosing would take place in an inpatient unit equipped for cardiac emergencies, with continuous cardiac monitoring until “there are no abnormal rhythms and the QTc interval has returned to near its pre-dose value, which could be as long as 36 hours”
• Participants could be genotyped for CYP2D6, and only fast and intermediate metabolisers included, with doses adjusted “if needed”
• Participants would stop certain medications, including opioid agonists, antipsychotics, antiemetics, and SSRIs
• There would be strict stopping rules (the agency highlights five such rules), and cognitive testing would be repeated at intervals for 12 months

The RFI is part of a broader effort by the U.S. Department of Health and Human Services to lightly coordinate ibogaine research, with at least two federal bodies, NIDA and ARPA-H, having committed ...