The Efficacy of Ibogaine in the Treatment of Addiction; an open label, single fixed dose pilot-study of the efficacy of ibogaine in opioid-dependent subjects
Open-label, single-arm Phase II pilot study (n=12) assessing a single fixed oral dose of ibogaine for reducing craving and opioid use in opioid-dependent patients with neuroimaging and electrophysiological secondary measures.
Details
Open-label, non-randomised, single-site Phase II pilot assessing the effects of one fixed oral dose of ibogaine in adults with opioid dependence; primary outcomes were relapse and subjective craving over six months.
Secondary outcomes included changes in brain activity measured by event related potentials (EEG) and functional MRI as markers of cue responsivity and cognitive processes related to craving; follow-ups occurred at 2, 4, 8, 12 and 24 weeks.
Safety evaluation focused on acute in‑hospital monitoring during opioid withdrawal and a six‑month post‑treatment safety assessment, with exclusion criteria targeting cardiac risk, severe psychiatric illness, pregnancy and interacting medications.