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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 17, 2022
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
International Center for Ethnobotanical Education, Research, and Service
Information provided by (Responsible Party):
Rafael Guimarães dos Santos, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE December 15, 2017
First Posted Date  ICMJE December 21, 2017
Last Update Posted Date May 17, 2022
Estimated Study Start Date  ICMJE October 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2017)
Time without using alcohol [ Time Frame: 0-12 months ]
Notebook of daily alcohol use
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
Time without using alcohol [ Time Frame: 12 months ]
Notebook of daily alcohol use
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
  • Subjective effects [ Time Frame: 0-72 hours ]
    Acute and subacute subjective effects
  • Biomarkers [ Time Frame: 0-24 hours ]
    Endocannabinoids, brain-derived neurotrophic factor (BDNF), interleukines
  • Cardiovascular effects [ Time Frame: 0-72 hours ]
    electrocardiogram
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • Biomarkers [ Time Frame: 12 months ]
    Endocannabinoids, brain-derived neurotrophic factor (BDNF), interleukines
  • Subjective effects [ Time Frame: 0-72 hours after dosing ]
    Acute and subacute subjective effects
  • Cardiovascular effects [ Time Frame: 0-72 hours after dosing ]
    electrocardiogram
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ibogaine in the Treatment of Alcoholism: a Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial
Official Title  ICMJE Tolerability and Efficacy of Ibogaine in the Treatment of Alcoholism: the First Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Group 1
    Ibogaine Hydrochloride 240 mg on day 1, placebo on day 4, placebo on day 7
    Intervention: Drug: Ibogaine Hydrochloride
  • Experimental: Group 2
    Ibogaine Hydrochloride 240 mg on day 1, Ibogaine Hydrochloride 320 mg on day 4, placebo on day 7
    Intervention: Drug: Ibogaine Hydrochloride
  • Experimental: Group 3
    Ibogaine Hydrochloride 240 mg on day 1, Ibogaine Hydrochloride 320 mg on day 4, Ibogaine Hydrochloride 400 mg on day 7
    Intervention: Drug: Ibogaine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rafael dos Santos, PhD 551636022703 banisteria@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03380728
Other Study ID Numbers  ICMJE 72938717.3.0000.5440
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Rafael Guimarães dos Santos, University of Sao Paulo
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Sao Paulo
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • International Center for Ethnobotanical Education, Research, and Service
Investigators  ICMJE
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
PRS Account University of Sao Paulo
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP