This open-label, single-arm Phase II pilot study (n=12) assesses a single fixed oral dose of ibogaine (700mg/70kg) for reducing craving and opioid use in opioid-dependent patients with neuroimaging and electrophysiological secondary measures.
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.
Open-label single fixed oral dose of ibogaine administered to opioid-dependent patients (single arm).
Oral powder formulation; fixed single dose
This pharmacokinetic study (n=14) on ibogaine (700mg/70kg) for opioid use disorder (OUD) finds significant variability in ibogaine clearance, strongly correlated with CYP2D6 genotype. Ibogaine plasma concentrations correlate with QTc prolongation and cerebellar effects, while neither ibogaine nor noribogaine correlate with the severity of opioid withdrawal symptoms.