Not Losing Momentum: Cross-Sectional Insights into Ibogaine Clinical Trials.
Damian Swieczkowski, Aleksander Kwaśny, Krzysztof Sadko, Wiesław Jerzy Cubała
Journal of Psychoactive Drugs April 18, 2025 DOI: 10.1080/02791072.2025.2491385 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Cross-sectional study Peer reviewed |
|---|---|
| Sample size | 9 |
| Population | Clinical trials of ibogaine for substance use disorders |
| Intervention | Ibogaine |
| Topics | Ibogaine |
| Keywords | Clinical trials Cross-sectional study Psychedelics Addiction treatment Substance abuse Clinical research Drug therapy |
| Citations | 1 |
| Key findings | Nine early-phase clinical trials on ibogaine show considerable methodological variability and a lack of large-scale, late-phase trials, limiting definitive conclusions about its safety and efficacy for substance use disorders. |
Abstract
Ibogaine, a non-classical psychedelic, has gained increasing attention as a potential treatment for substance use disorders (SUD); however, a lack of commercial interest and safety-related concerns limit its clinical development. This cross-sectional study investigates the current landscape of clinical trials involving ibogaine, a non-classical psychedelic, focusing on its safety and efficacy. We extracted data from ClinicalTrials.Gov, EU Clinical Trials (https://euclinicaltrials.eu/), the EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/), and the International Clinical Trials Registry Platform (World Health Organization). After rigorous screening and deduplication, we analyzed nine trials. Our findings revealed considerable variability in methodologies, including fixed-dose and ascending-dose designs, diverse inclusion and exclusion criteria, and differing primary and secondary outcomes. Early-phase trials dominate, primarily focusing on pharmacokinetics, withdrawal symptom reduction, and safety monitoring. Key findings indicate significant differences in how safety concerns are addressed, particularly regarding ibogaine's cardiovascular risk. While preliminary evidence suggests potential therapeutic benefits, the absence of large-scale, late-phase trials limits definitive conclusions. Our study underscores the need for a standardized clinical framework to ensure reliable assessments of ibogaine's efficacy and safety. Lessons from research on classical psychedelics, and MDMA could help improve trial design and reduce issues related to blinding and expectancy bias.
Comparable studies
Other cross-sectional and survey studies on ibogaine, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Examination of the Phenomenology of the Ibogaine Treatment Experience: Role of Altered States of Consciousness and Psychedelic Experiences. Individuals who used ibogaine in the past | 2017 | Retrospective survey | n = 27 |
| Adverse Health Outcomes of Psilocybin, LSD, MDMA, Ibogaine, and 5-MeO-DMT Nationally representative sample of US adults | 2026 | Cross-sectional survey |
Citations in the library
Cites 26
- The ibogaine medical subculture. Journal of Ethnopharmacology January 4, 2008
- Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review Journal of Psychopharmacology August 26, 2022
- Adverse Events in Studies of Classic Psychedelics JAMA Psychiatry September 4, 2024
- Ibogaine Detoxification Transitions Opioid and Cocaine Abusers Between Dependence and Abstinence: Clinical Observations and Treatment Outcomes. Frontiers in Pharmacology 2018
- The clinical pharmacology and potential therapeutic applications of 5‐methoxy‐N,N‐dimethyltryptamine (5‐MeO‐DMT) Journal of Neurochemistry February 12, 2022
and 21 more in the library