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

NCT03380728 | Completed Phase 2

• 1 other identifier: 72938717.3.0000.5440
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (1)

• Time without using alcohol

  Daily alcohol use

  0-1 month

Secondary Outcomes (2)

• Subjective effects

  0-12 hours

• Cardiovascular effects

  0-72 hours

Study Arms (1)

Ibogaine

EXPERIMENTAL

Ibogaine Hydrochloride 240 mg on day 1, placebo on day 4, placebo on day 7

Drug: Ibogaine Hydrochloride

Interventions

Ibogaine Hydrochloride DRUG

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 in 3 different groups.

Also known as: Placebo

Ibogaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Literate people
• Diagnosis of alcoholism assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-V)
• History of at least two previous failed treatments for alcoholism (with drug use and / or psychotherapy)
• Signing the Free and Informed Consent Form.

You may not qualify if:

• Presence of any psychiatric diagnosis (excluding alcohol / tobacco / nicotine abuse / dependence) assessed by the SCID-V
• Presence of clinical disease (especially cardiovascular and hepatic diseases), based on interview, physical and laboratory examination (hemogram and electrocardiogram, ECG)
• Absence of family or personal history of bipolar disorder and psychotic disorders
• Absence of recent symptoms of hypomania, mania or psychosis
• Non-literate people
• Pregnant or lactating women
• Recent use of illicit drugs (confirmed by examination in urine).

Sponsors & Collaborators

• University of Sao Paulo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• International Center for Ethnobotanical Education, Research, and Service: collaborator

Study Sites (1)

Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Related Links

• dos Santos RG, Bouso JC, Hallak JEC. The antiaddictive effects of ibogaine: A systematic literature review of human studies. Journal of Psychedelic Studies 1(1): 20-28, 2017.
• Clare W et al. Detoxification from methadone using low, repeated, and increasing doses of ibogaine: A case report. Journal of Psychedelic Studies 1(1): 29-34.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rafael dos Santos, PhD

  Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

  PRINCIPAL INVESTIGATOR

• Jaime Hallak, PhD

  Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow, Principal Investigator

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 21, 2017
• Study Start: October 30, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)