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

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ClinicalTrials.gov Identifier: NCT03380728
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Rafael Guimarães dos Santos, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Ibogaine Hydrochloride Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Tolerability and Efficacy of Ibogaine in the Treatment of Alcoholism: the First Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Ibogaine Hydrochloride 240 mg on day 1, placebo on day 4, placebo on day 7
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.
Other Name: Placebo

Experimental: Group 2
Ibogaine Hydrochloride 240 mg on day 1, Ibogaine Hydrochloride 320 mg on day 4, placebo on day 7
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.
Other Name: Placebo

Experimental: Group 3
Ibogaine Hydrochloride 240 mg on day 1, Ibogaine Hydrochloride 320 mg on day 4, Ibogaine Hydrochloride 400 mg on day 7
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.
Other Name: Placebo




Primary Outcome Measures :
  1. Time without using alcohol [ Time Frame: 0-12 months ]
    Notebook of daily alcohol use


Secondary Outcome Measures :
  1. Subjective effects [ Time Frame: 0-72 hours ]
    Acute and subacute subjective effects

  2. Biomarkers [ Time Frame: 0-24 hours ]
    Endocannabinoids, brain-derived neurotrophic factor (BDNF), interleukines

  3. Cardiovascular effects [ Time Frame: 0-72 hours ]
    electrocardiogram



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380728


Contacts
Contact: Rafael dos Santos, PhD 551636022703 banisteria@gmail.com

Locations
Brazil
Ribeirão Preto Medical School Active, not recruiting
Ribeirão Preto, São Paulo, Brazil, 14048900
Sponsors and Collaborators
University of Sao Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Rafael dos Santos, PhD Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
Study Director: Jaime Hallak, PhD Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

Additional Information:
Responsible Party: Rafael Guimarães dos Santos, Postdoctoral Fellow, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03380728     History of Changes
Other Study ID Numbers: 72938717.3.0000.5440
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ibogaine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action