The aim of the present study is to evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12 alcoholic patients.
This phase II, escalating-dose study tests oral ibogaine in people with alcohol use disorder; an initial open-label lead-in (first 3 participants, 20–400 mg) precedes a randomized placebo-controlled allocation for the remaining participants.
Participants are hospitalised for 20 days, receive three escalating doses (examples: 240, 320, 400 mg) and are followed at 7, 14, 21 days and 1, 3, 6, 12 months for alcohol and other drug use and safety monitoring.
Escalating oral ibogaine dosing (240–400 mg) with initial open-label lead-in then randomized dosing groups.
First 3 patients open-label 20–400 mg; subsequent participants randomised to 240, 320 or 400 mg.
Placebo control for randomized portion.
Placebo administered in randomized groups for days corresponding to dosing schedule.