Status:
COMPLETED
Ibogaine in the Treatment of Alcoholism: an Open-label Escalating-dose Trial
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03380728
Start Date
October 30 2022
End Date
October 30 2024
Last Update
November 26 2024
Active Locations (1)
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1
Ribeirão Preto Medical School
Ribeirão Preto, São Paulo, Brazil, 14048900