Feasibility, safety and preliminary effects of ibogaine in patients with moderate and severe alcohol use disorder: a pilot, open-label study.

Abstract

<h4>Introduction</h4>Ibogaine is a natural hallucinogen with emerging evidence for treating substance use disorders. However, its cardiovascular effects are not fully known, and most clinical data focus on opioid dependence, with limited data for Alcohol Use Disorder (AUD). This study assessed the feasibility, safety, and preliminary effects of ibogaine in patients with AUD.<h4>Method</h4>In this preliminary open-label, pilot, feasibility study, nine adults with moderate to severe AUD received oral ibogaine hydrochloride in a sequential order: volunteer 1 20/40/80 mg; volunteer 2 80/160/240 mg, volunteer 3: 240/320 mg, and the next six received a single 400 mg dose. Participants were hospitalized 24-48 hours before dosing with continuous monitoring. Primary outcome included safety measures (QTc interval, vital signs, laboratory tests, adverse effects, and psychiatric assessments). Secondary outcome included alcohol and substance use.<h4>Results</h4>QTc alterations, including transient prolongation and shortening, occurred in five patients. Mild/moderate blood pressure alterations were also observed. Mild/moderate adverse effects were common (drowsiness, nausea, anxiety), particularly at higher doses (240-400 mg). No serious adverse effects were observed, but two patients needed medication for psychomotor agitation, insomnia and hypertension. Most participants reported reductions in alcohol use, but only five completed the study.<h4>Discussion</h4>Moderate doses of ibogaine showed a cardiotoxic potential that demands rigorous cardiovascular screening and continuous monitoring. Patients reported reduced substance use, but motivation and placebo effects could explain these results. Randomized controlled trials are needed to confirm efficacy and establish protocols with safety parameters.

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