FDA asks how ibogaine trials should be run, with comments due November 20; Washington's ibogaine bill stayed in committee

What the FDA is asking

On October 6, 2026, the FDA published a request for information, "Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products" (91 FR 63563, docket FDA-2026-N-10429). It describes the approaches the agency is considering for early-phase trials and asks for comments on dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight.¹ Electronic comments close at 11:59 p.m. Eastern on November 20. As of the Federal Register's check of Regulations.gov on the evening of November 2 (6:55 p.m. Pacific), the docket showed 32 comments.¹²

The notice says HHS "is funding clinical development of ibogaine," through ARPA-H and the National Institute on Drug Abuse, and that "the first federally supported trials are expected to study ibogaine in adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD)."¹

Why the FDA is cautious

The FDA lists serious safety risks: prolongation of the heart's QTc interval with a risk of life-threatening arrhythmia, neurotoxicity in nonclinical studies, and "uncertainty regarding an appropriate starting dose for humans."¹ Its preliminary thinking is an open-label trial in which small groups of participants each receive one dose, with the dose rising from one group to the next after review. The care setting would be an inpatient unit equipped to manage a life-threatening arrhythmia, with continuous heart monitoring that could last as long as 36 hours, and a safety committee that includes a cardiologist.¹ The agency says the notice "does not establish legally enforceable requirements or regulatory expectations, nor does it represent FDA's final views."¹

Washington's ibogaine record

SB 5204, "Concerning ibogaine-assisted therapy," sponsored by Sen. Jesse Salomon, was introduced January 13, 2025. Its legal title describes "studying outcomes of ibogaine-assisted therapy to treat adults with opioid use disorder." Its last recorded action, on January 12, 2026, reads "By resolution, reintroduced and retained in present status," and it stayed in the Senate Health and Long-Term Care Committee.³

The state has paid for ibogaine research without the bill. The 2024 supplemental budget funded UW's Center for Novel Therapeutics in Addiction Psychiatry "for an initial study of ibogaine assisted therapy."⁴ The 2025-27 budget funds a UW "prospective, randomized cohort study between July 1, 2025, and June 30, 2027" of ibogaine-assisted therapy "conducted through a licensed clinic in North America" for adults with opioid use disorder.⁵ The center's director, Nathan Sackett,⁶ co-wrote a 2026 commentary warning that "detoxification" from methadone or buprenorphine in favor of "an as-yet unproven therapy like ibogaine could result in an increased risk of opioid overdose for some."⁷

Ibogaine is a Schedule I substance under federal and Washington law.⁸⁹ Federal trial rules would shape any Washington research site. Colorado's new natural medicine law takes another route, with a state ibogaine research pilot (see our Colorado rules post). Our psychedelics in Seattle entry covers ibogaine's status, the Seattle research entry covers UW's addiction psychiatry work, and the timeline dates the bills.