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