5.4.1. Ibogaine for OUD
An open-label study of 27 treatment-seeking participants with OUD and/or cocaine use disorder received a fixed-dose of either 500, 600, or 800 mg ibogaine HCl in a 12-day inpatient setting showed statistically significant reductions in various subscales of the Heroin Craving Questionnaire (HCQN-29) by the time of discharge.104An open-label study of 14 participants with OUD who took ibogaine-HCl (10 mg/kg orally) showed temporary QTc prolongation on an electrocardiogram (EKG)—a condition that may elevate the risk of irregular heart rhythm and sudden death—and other side effects, including ataxia.105 Both studies are limited by their small size, lack of blinding, and short duration/limited follow-up.
Other case series exist of patients who received treatments in countries where prescription ibogaine is legal. These studies reported reductions in Addiction Severity Index-Lite (ASI-Lite), and Subjective Opioid Withdrawal Scale (SOWS) up to one year post-treatment, with some suggestion of decreased family/social status problems.106 Notable are the serious safety concerns raised within this study concerning a patient that died for which the cause was attributed to cardiac arrythmias post-ibogaine use. Another series of participants surveyed post-ibogaine treatment provide some indication suggesting that despite return to use in a large proportion of the sample one to two years after ibogaine exposure, there was some indication of decreased opioid use, improvements in mood and anxiety effects, and other improvements in psychosocial measures.107 Other retrospective, observational and case series provide additional data concerning dosing and the effect of ibogaine on withdrawal and other addiction outcomes.108,109
There are two currently registered clinical trials investigating the use of ibogaine for OUD. One is a Phase 2 RCT including patients with OUD who receive methadone treatment who will be administered ascending doses of ibogaine for opioid withdrawal [NCT04003948].110 The other is a Phase 1/2a dosing study of healthy volunteers followed by a randomized, double-blind, placebo-controlled study in patients seeking medically supervised opioid withdrawal treatment [NCT05029401].111