Trials Sponsors Conditions Drugs Pricing

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 HydrochlorideDrug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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)

Sponsors & Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Governmentcollaborator
International Center for Ethnobotanical Education, Research, and Service
Othercollaborator

Study Sites (1)

Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14048900, Brazil

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental 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

Enrollment

9 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Ibogaine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Ibogaine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations