Feasibility, safety and preliminary effects of ibogaine in patients with moderate and severe alcohol use disorder: a pilot, open-label study
Juliana Mendes Rocha, Renan Massanobu Maekawa, José Augusto Silva Reis, Lorena Terene Lopes Guerra, Giordano Novak Rossi, Lucas Silva Rodrigues, Bianca Villanova, Anna Beatriz Vicentini, Caio César De Paula, José Carlos Bouso, Jaime E. C. Hallak, Rafael G. Dos Santos
Trends in Psychiatry and Psychotherapy 2026 DOI: 10.47626/2237-6089-2026-1437 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label pilot feasibility study Randomized Peer reviewed |
|---|---|
| Sample size | 9 |
| Population | Adults with moderate to severe alcohol use disorder |
| Intervention | Ibogaine hydrochloride |
| Dose | Sequential dosing: volunteer 1: 20/40/80 mg; volunteer 2: 80/160/240 mg; volunteer 3: 240/320 mg; next six: single 400 mg dose |
| Topics | Addiction Ibogaine |
| Keywords | Alcohol consumption Alcohol intake Medline Adverse effect |
| Key points | Ibogaine produced transient QTc interval changes in five of nine patients and mild to moderate blood pressure alterations, with no serious adverse effects. Most participants reported reduced alcohol use, but only five completed the study, and the authors caution that motivation and placebo effects may explain these reports. |
Abstract
Introduction: 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.
Method: 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.
Results: 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.
Discussion: 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.
In the evidence
This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.
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Ibogaine produced transient QTc changes in five of nine patients and mild to moderate blood pressure alterations with no serious adverse effects; most reported reduced alcohol use, but only five completed the study and the authors caution that motivation and placebo effects may explain these reports.
Synthesized
Comparable studies
Other non-randomized and open-label trials on ibogaine for addiction, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Medication Development of Ibogaine as a Pharmacotherapy for Drug Dependencea. Cocaine-dependent patients | 1998 | Rising tolerance study (Phase I trial) | |
| Ibogaine Detoxification Transitions Opioid and Cocaine Abusers Between Dependence and Abstinence: Clinical Observations and Treatment Outcomes. Human volunteers seeking to detoxify from opioids or cocaine | 2018 | Open-label case series | n = 191 |
| Safety of ibogaine administration in detoxification of opioid-dependent individuals: a descriptive open-label observational study. Patients with opioid use disorder on opioid maintenance treatment who failed to reach... | 2022 | Open-label observational study | n = 14 |
| Hallucinogen Persisting Perception Disorder After Ibogaine Treatment for Opioid Dependence. One healthy adult volunteer | 2018 | Case study (open-label trial, single subject) | n = 1 |