Safety of ibogaine administration in detoxification of opioid-dependent individuals: a descriptive open-label observational study.
Thomas Knuijver, Arnt Schellekens, Maarten Belgers, Rogier Donders, Toon Van Oosteren, Kees Kramers, Robbert J. Verkes
Addiction (Abingdon, England) 2022 DOI: 10.1111/add.15448 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label observational study Peer reviewed |
|---|---|
| Sample size | 14 |
| Population | Patients with opioid use disorder on opioid maintenance treatment who failed to reach abstinence with standard care |
| Intervention | Ibogaine-HCl |
| Dose | 10 mg/kg |
| Duration | At least 24 hours |
| Topics | Addiction Ibogaine |
| Keywords | Cardiac safety Cerebellar toxicity Detoxification Ibogaine: ibogaine Ataxia Withdrawal effects Psychomimetic effects Significant qtc prolongation |
| Citations | 49 |
| Key findings | Ibogaine treatment induced clinically relevant but reversible QTc prolongation, bradycardia, and severe ataxia in patients with opioid use disorder. |
Abstract
Ibogaine is an indole alkaloid used in rituals of the African Bwiti tribe. It is also used in non-medical settings to treat addiction. However, ibogaine has been linked to several deaths, mainly due to cardiac events called torsades des pointes preceded by QTc prolongation as well as other safety concerns. This study aimed to evaluate the cardiac, cerebellar and psychomimetic safety of ibogaine in patients with opioid use disorder. A descriptive open-label observational study. Department of psychiatry in a university medical center, the Netherlands. Patients with opioid use disorder (n = 14) on opioid maintenance treatment with a lasting wish for abstinence, who failed to reach abstinence with standard care. After conversion to morphine-sulphate, a single dose of ibogaine-HCl 10 mg/kg was administered and patients were monitored at regular intervals for at least 24 hours assessing QTc, blood pressure and heart rate, scale for the assessment and rating of ataxia (SARA) to assess cerebellar side effects and the delirium observation scale (DOS) to assess psychomimetic effects. The maximum QTc (Fridericia) prolongation was on average 95ms (range 29-146ms). Fifty percent of subjects reached a QTc of over 500ms during the observation period. In six out 14 subjects prolongation above 450ms lasted beyond 24 hours after ingestion of ibogaine. No torsades des pointes were observed. Severe transient ataxia with inability to walk without support was seen in all patients. Withdrawal and psychomimetic effects were mostly well-tolerated and manageable (11/14 did not return to morphine within 24 hours, DOS scores remained below threshold). This open-label observational study found that ibogaine treatment of patients with opioid use disorder can induce a clinically relevant but reversible QTc prolongation, bradycardia, and severe ataxia.
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 |
| Feasibility, safety and preliminary effects of ibogaine in patients with moderate and severe alcohol use disorder: a pilot, open-label study Adults with moderate to severe alcohol use disorder | 2026 | Open-label pilot feasibility study | n = 9 |
| Hallucinogen Persisting Perception Disorder After Ibogaine Treatment for Opioid Dependence. One healthy adult volunteer | 2018 | Case study (open-label trial, single subject) | n = 1 |
Citations in the library
Cited by 16
- Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism. Neuropsychopharmacology July 21, 2023
- IUPHAR - invited review - Ibogaine - A legacy within the current renaissance of psychedelic therapy. Pharmacological Research April 1, 2023
- Identifying setting factors associated with improved ibogaine safety: a systematic review of clinical studies. European Archives of Psychiatry and Clinical Neuroscience October 1, 2023
- Main targets of ibogaine and noribogaine associated with its putative anti-addictive effects: A mechanistic overview. Journal of psychopharmacology (Oxford, England) December 1, 2023
- The pharmacokinetics and pharmacodynamics of ibogaine in opioid use disorder patients. Journal of psychopharmacology (Oxford, England) May 1, 2024
and 11 more in the library
Cites 24
- Degeneration of Purkinje cells in parasagittal zones of the cerebellar vermis after treatment with ibogaine or harmaline. Neuroscience July 1, 1993
- A preliminary investigation of ibogaine: case reports and recommendations for further study. Journal of Substance Abuse Treatment 1994
- Treatment of opioid use disorder with ibogaine: detoxification and drug use outcomes. The American Journal of Drug and Alcohol Abuse 2018
- Ibogaine treatment outcomes for opioid dependence from a twelve-month follow-up observational study. The American Journal of Drug and Alcohol Abuse 2018
- The Anti-Addiction Drug Ibogaine and the Heart: A Delicate Relation Molecules January 29, 2015
and 19 more in the library