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Medication Development of Ibogaine as a Pharmacotherapy for Drug Dependencea.

Deborah C. Mash, Craig A. Kovera, Billy E Buck, Michael D Norenberg, Paul Shapshak, William Lee Hearn, Juan Sanchez‐ramos

Annals of the New York Academy of Sciences May 1, 1998 DOI: 10.1111/j.1749-6632.1998.tb08242.x (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Rising tolerance study (Phase I trial) Peer reviewed
Population Cocaine-dependent patients
Intervention Ibogaine
Topics Ibogaine Addiction
Citations 111
Key findings Ibogaine's safety and pharmacokinetics are being assessed in a Phase I trial to determine if efficacy trials for cocaine dependency are warranted.

Abstract

The potential for deriving new psychotherapeutic medications from natural sources has led to renewed interest in rain forest plants as a source of lead compounds for the development of antiaddiction medications. Ibogaine is an indole alkaloid found in the roots of Tabernanthe iboga (Apocynaceae family), a rain forest shrub that is native to equatorial Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and in higher doses as a sacrament in religious rituals. Members of American and European addict self-help groups have claimed that ibogaine promotes long-term drug abstinence from addictive substances, including psychostimulants and cocaine. Anecdotal reports attest that a single dose of ibogaine eliminates withdrawal symptoms and reduces drug cravings for extended periods of time. The purported antiaddictive properties of ibogaine require rigorous validation in humans. We have initiated a rising tolerance study using single administration to assess the safety of ibogaine for the treatment of cocaine dependency. The primary objectives of the study are to determine safety, pharmacokinetics and dose effects, and to identify relevant parameters of efficacy in cocaine-dependent patients. Pharmacokinetic and pharmacodynamic characteristics of ibogaine in humans are assessed by analyzing the concentration-time data of ibogaine and its desmethyl metabolite (noribogaine) from the Phase I trial, and by conducting in vitro experiments to elucidate the specific disposition processes involved in the metabolism of both parent drug and metabolite. The development of clinical safety studies of ibogaine in humans will help to determine whether there is a rationale for conducting efficacy trials in the future.

In the evidence

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  • Describes an ongoing Phase I rising-tolerance study assessing safety, pharmacokinetics, and dose effects of ibogaine in cocaine-dependent patients to determine whether efficacy trials are warranted.

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Comparable studies

Other non-randomized and open-label trials on ibogaine for addiction, most cited first.

Study Year Design Participants
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
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

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