NCT03380728

Ibogaine in the Treatment of Alcoholism: an Open-label Escalating-dose Trial

Completed Phase 2 Last updated 26 November 2024

What this trial tests

Phase 2 trial testing Ibogaine Hydrochloride in Alcoholism in 9 participants. Completed in 30 October 2024.

Timeline

30 October 2022

Primary endpoint
30 October 2024

30 October 2024

Quick facts

Lead sponsor	University of Sao Paulo
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	30 October 2022
Primary completion	30 October 2024
Estimated completion	30 October 2024
Sites	1 location across Brazil

Drugs / interventions tested

• Ibogaine Hydrochloride — full drug profile →

Conditions studied

• Alcoholism — all drugs for Alcoholism →

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 65, any sex, with Alcoholism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Approximately 5% of the world's adult population has some alcohol-related disorder, which in addition is associated with 3% of all deaths in the world. In Brazil, harmful use and dependence on alcohol reach about 10% of the population, with alcohol being one of the main factors of disease and mortality. Although the medications currently used have some efficacy, the adverse effects and relatively long time of treatment are factors that may reduce patients' motivation to continue taking the medication correctly. Therefore, it is necessary to conduct research with new drugs for the treatment of alcoholism. Ibogaine is an alkaloid present in the bush Tabernanthe iboga (iboga), a plant from Central Africa traditionally used in countries such as Gabon and Cameroon. Animal studies and case series suggest that one or a few doses of ibogaine significantly reduce withdrawal symptoms and the intensity of use of various drugs, including opioids, psychostimulants, and alcohol. However, there are no controlled clinical studies that have explored these effects. The aim of the present study is to evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12 alcoholic patients. Each patient will be hospitalized for 20 days and receive 3 increasing doses of ibogaine. The first 3 patients will receive oral doses of 20 to 400 mg of ibogaine in an open-label design. If the 3 higher doses (240, 320 and 400 mg) are well tolerated, the next 9 volunteers will receive these doses or placebo randomly. The volunteers will also be evaluated 7, 14 and 21 days and 1, 3, 6 and 12 months after leaving the hospital to monitor the consumption of alcohol and other drugs.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychedelic therapy in the treatment of addiction: the past, present and future.
   Zafar R, Siegel M, Harding R, Barba T, et al · · 2023 · cited 47× · PMID 37377473 · DOI 10.3389/fpsyt.2023.1183740
2. Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism.
   Mitchell JM, Anderson BT. · · 2024 · cited 32× · PMID 37479859 · DOI 10.1038/s41386-023-01656-7
3. The Use of Psychedelics in the Treatment of Medical Conditions: An Analysis of Currently Registered Psychedelics Studies in the American Drug Trial Registry.
   Kurtz JS, Patel NA, Gendreau JL, Yang C, et al · · 2022 · cited 19× · PMID 36259015 · DOI 10.7759/cureus.29167
4. The Therapeutic Potential of Psychedelics in Treating Substance Use Disorders: A Review of Clinical Trials.
   Hogea L, Tabugan DC, Costea I, Albai O, et al · · 2025 · cited 8× · PMID 40005395 · DOI 10.3390/medicina61020278
5. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries.
   Greene MC, Kane J, Alto M, Giusto A, et al · · 2023 · cited 7× · PMID 37158538 · DOI 10.1002/14651858.cd013350.pub2
6. Psychedelic Drugs in Mental Disorders: Current Clinical Scope and Deep Learning-Based Advanced Perspectives.
   Kim SH, Yang S, Jung J, Choi J, et al · · 2025 · cited 5× · PMID 40112231 · DOI 10.1002/advs.202413786
7. Drug Transporters ABCB1 (P-gp) and OATP, but not Drug-Metabolizing Enzyme CYP3A4, Affect the Pharmacokinetics of the Psychoactive Alkaloid Ibogaine and its Metabolites.
   F Martins ML, Heydari P, Li W, Martínez-Chávez A, et al · · 2022 · cited 5× · PMID 35308219 · DOI 10.3389/fphar.2022.855000
8. Unveiling GABA and Serotonin Interactions During Neurodevelopment to Re-Open Adult Critical Periods for Neuropsychiatric Disorders.
   Beretta E, Cuboni G, Deidda G. · · 2025 · cited 4× · PMID 40564972 · DOI 10.3390/ijms26125508