Clinical TrialOpioid Use Disorder (OUD)IbogaineIbogaineCompleted

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

This Phase-II RCT (n=20) in Spain randomises methadone-maintained patients to fixed ibogaine (6×100 mg) or ascending ibogaine doses (100→600 mg across six administrations) given when opioid withdrawal appears to support methadone detoxification.

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Methadone dependence is difficult to detoxify; this phase II randomised trial at Hospital Universitari Sant Joan evaluates whether repeated oral ibogaine administrations facilitate methadone tapering and detoxification.

Participants are randomised to a fixed regimen (six 100 mg doses) or an ascending regimen (100→600 mg over six administrations). Ibogaine is given when clinical opioid withdrawal appears; methadone is interrupted and reduced as specified.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

Fixed dose

experimental

Ibogaine hydrochloride 100 mg per administration, six administrations.

Interventions

  • Ibogaine100 mg
    via Oral• as needed when withdrawal appears• 6 doses total

    Six administrations of 100 mg each; methadone interrupted; if withdrawal recurs half prior methadone dose given.

Ascending dose

experimental

Ibogaine hydrochloride ascending doses over six administrations.

Interventions

  • Ibogaine100 - 600 mg
    via Oral• as needed when withdrawal appears• 6 doses total

    Ascending single doses 100→200→300→400→500→600 mg over six administrations; methadone interrupted; if withdrawal recurs half prior methadone dose given.

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* Aged between 18 and 60 years.\n* Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m2).\n* Normal clinical records and physical examination.\n* Subjects without organic disorders.\n* 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.\n* 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.\n* Having not participated in another clinical trial in the last 2 months.\n* Free acceptance to participate in the study by obtains signed informed consent form approved by the ethics committee.\n* 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

  • Exclusion Criteria:\n\n* Background of allergy, idiosyncrasy or hypersensitivity to drugs.\n* 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.\n* Viral activity for hepatitis B, C or HIV.\n* Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.\n* History of severe psychiatric disease like psychosis, bipolar disorder or dissociative disorders, or a high risk to develop them as reported by psychometric questionnaires.\n* Past or current risk of suicide.\n* Having undergone major surgery during the previous 6 months before the enrollment.\n* 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).\n* Not understanding the nature of the study and potential consequences.\n* 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.\n* Pregnancy or lactation status (females).\n* Not understanding the informed consent.

Study Details

Locations

Hospital Universitari Sant Joan — Reus, Tarragona, Spain

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