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Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003948
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : August 31, 2022
Sponsor:
Collaborators:
Multidisciplinary Association for Psychedelic Studies
University Rovira i Virgili
Universidad Autonoma de Madrid
Hospital Universitari Sant Joan de Reus
University of Sao Paulo
Information provided by (Responsible Party):
International Center for Ethnobotanical Education, Research, and Service

Study Description
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Brief Summary:
Methadone is a very long-acting opiate very difficult to detox from. In Spain there are a lot of methadone dependent people in the aftermath of the heroin epidemic of the 1980s. Many have been dependent for more than 15 years and a number of them have a relatively stable life condition (have work, family, housing, etc.) and a relatively good health condition in comparison with current heroin users. This Phase-II RCT is a collaboration with the Sant Joan Hospital in Reus, Spain. Twenty patients on the methadone maintenance program will be recruited. Patients will be randomized to two groups: One receiving 6 doses of 100 mg of ibogaine; and the other one receiving ascending doses of ibogaine (100-200-300-400-500-600). Methadone use will be interrupted and for both groups ibogaine will be administered when clinical symptoms of opioid withdrawal appear. After an ibogaine dose, when symptoms of opioid withdrawal appear again, half of the methadone dose used last time will be administered. By doing so, methadone doses will be progressively reduced until no withdrawal symptoms appear.

Condition or disease Intervention/treatment Phase
Drug Dependence Drug Use Disorders Opioid Dependence Drug: Ibogaine Hydrochloride Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preliminar Efficacy and Safety of Ibogaine in the Treatment of Methadone
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Methadone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fixed dose
Ibogaine Hydrochloride 100 mg on each administration.
 Drug: Ibogaine Hydrochloride
Fixed or ascending doses of ibogaine will be administered for the treatment of opioid withdrawal syndrome.
Experimental: Ascending dose
Ibogaine Hydrochloride on ascending doses (100-200-300-400-500-600).
 Drug: Ibogaine Hydrochloride
Fixed or ascending doses of ibogaine will be administered for the treatment of opioid withdrawal syndrome.


Outcome Measures
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Primary Outcome Measures :
  1. Methadone dose [ Time Frame: 0-6 months ]
    Rate of decrease of methadone dose used


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 0-24 hours ]
    Description of adverse events found at different doses of ibogaine

  2. Cardiovascular effects [ Time Frame: 0-24 hours ]
    Electrocardiogram (QT interval, ST wave)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 18 and 60 years.
  • Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m2).
  • Normal clinical records and physical examination.
  • Subjects without organic disorders.
  • Laboratory tests (hematology, biochemistry and urinalysis) within the range of normal values, according to the laboratory reference values of the "Hospital Universitari Sant Joan de Reus". Variations may be admitted according to the clinical criteria of the Principal Investigator.
  • Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
  • Having not participated in another clinical trial in the last 2 months.
  • Free acceptance to participate in the study by obtains signed informed consent form approved by the ethics committee.
  • ECG values within the range of normal values (PR < 240 ms, QRS < 110 ms and QTc < 430 ms in men and QTc < 450 ms in women, and heart rate >50 bpm.

Exclusion Criteria:

  • Background of allergy, idiosyncrasy or hypersensitivity to drugs..
  • Intake of any medication within 2 weeks prior taking the study treatment (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor before the drug administration.
  • Viral activity for hepatitis B, C or HIV.
  • Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
  • History of severe psychiatric disease like psychosis, bipolar disorder or dissociative disorders, or a high risk to develop them as reported by psychometric questionnaires.
  • Past or current risk of suicide.
  • Having undergone major surgery during the previous 6 months before the enrollment.
  • Positive results of the drugs at screening period or the day before starting treatment period: Amphetamines, Cocaine, Ethanol, Opiates (not methadone), and not prescribed Benzodiazepines (positive results may be repeated at the discretion of the PI).
  • Not understanding the nature of the study and potential consequences.
  • 12 lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec for men and ≥450 for women, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
  • Pregnancy or lactation status (females).
  • Not understanding the informed consent.
Contacts and Locations
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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): NCT04003948


Contacts
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Contact: Genís Ona, MSc 675553344 ext +34 genisona@iceers.org
Contact: José Carlos Bouso, PhD jcbouso@iceers.org

Locations
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Spain
Hospital Universitari Sant Joan Recruiting
Reus, Tarragona, Spain, 43204
Contact: Tre Borras, MD         
Sponsors and Collaborators
International Center for Ethnobotanical Education, Research, and Service
Multidisciplinary Association for Psychedelic Studies
University Rovira i Virgili
Universidad Autonoma de Madrid
Hospital Universitari Sant Joan de Reus
University of Sao Paulo
Investigators
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Principal Investigator: José Carlos Bouso, PhD International Center for Ethnobotanical Education, Research, and Service
Principal Investigator: Tre Borràs, MD Hospital Universitari Sant Joan de Reus
Study Director: Genís Ona, MSc International Center for Ethnobotanical Education, Research, and Service
More Information
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Responsible Party: International Center for Ethnobotanical Education, Research, and Service
ClinicalTrials.gov Identifier: NCT04003948    
Other Study ID Numbers: IBO-METAD-001
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Center for Ethnobotanical Education, Research, and Service:
Ibogaine
Methadone
Drug dependence
Addiction
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Narcotic-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