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

Preliminar Efficacy and Safety of Ibogaine in the Treatment of Methadone

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Dependence; Drug Dependence; Drug Use Disorders
• Intervention / Treatment: Drug: Ibogaine Hydrochloride

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Genís Ona, MSc; Phone Number: +34 675553344; Email: genisona@iceers.org
• Study Contact Backup: Name: José Carlos Bouso, PhD; Email: jcbouso@iceers.org

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Recruiting
      • Hospital Universitari Sant Joan
      • Contact: Tre Borras, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Methadone dose	Rate of decrease of methadone dose used	0-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Description of adverse events found at different doses of ibogaine	0-24 hours
Cardiovascular effects	Electrocardiogram (QT interval, ST wave)	0-24 hours

Collaborators and Investigators

• Sponsor: International Center for Ethnobotanical Education, Research, and Service
• Collaborators: University of Sao Paulo; Universidad Autonoma de Madrid; University Rovira i Virgili; Multidisciplinary Association for Psychedelic Studies; Hospital Universitari Sant Joan de Reus
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Methadone; Addiction; Ibogaine; Drug dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Psychotropic Drugs; Hallucinogens; Ibogaine
• Other Study ID Numbers: IBO-METAD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No