Ibogaine in the Treatment of Alcoholism: a Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial

Alcoholism Clinical Trial

Official title:

Tolerability and Efficacy of Ibogaine in the Treatment of Alcoholism: the First Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03380728
• Other study ID #: 72938717.3.0000.5440
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: October 30, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Ibogaine Hydrochloride
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.

Locations

Country	Name	City	State
Brazil	Ribeirão Preto Medical School	Ribeirão Preto	São Paulo

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., International Center for Ethnobotanical Education, Research, and Service

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time without using alcohol	Daily alcohol use	0-1 month
Secondary	Subjective effects	Acute and subacute subjective effects	0-12 hours
Secondary	Cardiovascular effects	Electrocardiogram	0-72 hours

External Links

•   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.
•   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.