连全球医疗资源，享前沿医疗服务
4006 776 356
免费咨询 9:00-18:00
免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification
Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification
Study Description
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
| 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, 2021 |
| Estimated Study Completion Date : | September 15, 2022 |
Arms and Interventions
| 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
Primary Outcome Measures :
- Methadone dose [ Time Frame: 0-6 months ]Rate of decrease of methadone dose used
Secondary Outcome Measures :
- Adverse events [ Time Frame: 0-24 hours ]Description of adverse events found at different doses of ibogaine
- Cardiovascular effects [ Time Frame: 0-24 hours ]Electrocardiogram (QT interval, ST wave)
Eligibility Criteria
| 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
Contacts
| Contact: Genís Ona, MSc | 675553344 ext +34 | genisona@iceers.org | |
| Contact: José Carlos Bouso, PhD | jcbouso@iceers.org |
Locations
| 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
| 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 |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 27, 2019 | |||||||||
| First Posted Date ICMJE | July 1, 2019 | |||||||||
| Last Update Posted Date | November 4, 2020 | |||||||||
| Actual Study Start Date ICMJE | October 28, 2020 | |||||||||
| Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Methadone dose [ Time Frame: 0-6 months ] Rate of decrease of methadone dose used
|
|||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
|
|||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification | |||||||||
| Official Title ICMJE | Preliminar Efficacy and Safety of Ibogaine in the Treatment of Methadone | |||||||||
| 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 2 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
|||||||||
| Condition ICMJE |
|
|||||||||
| Intervention ICMJE | Drug: Ibogaine Hydrochloride
Fixed or ascending doses of ibogaine will be administered for the treatment of opioid withdrawal syndrome.
|
|||||||||
| Study Arms ICMJE |
|
|||||||||
| 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 | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
20 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | September 15, 2022 | |||||||||
| Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender ICMJE |
|
|||||||||
| Ages ICMJE | 18 Years to 60 Years (Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
|
|||||||||
| Listed Location Countries ICMJE | Spain | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT04003948 | |||||||||
| Other Study ID Numbers ICMJE | IBO-METAD-001 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
|
|||||||||
| IPD Sharing Statement ICMJE |
|
|||||||||
| Responsible Party | International Center for Ethnobotanical Education, Research, and Service | |||||||||
| Study Sponsor ICMJE | International Center for Ethnobotanical Education, Research, and Service | |||||||||
| Collaborators ICMJE |
|
|||||||||
| Investigators ICMJE |
|
|||||||||
| PRS Account | International Center for Ethnobotanical Education, Research, and Service | |||||||||
| Verification Date | November 2020 | |||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||||||||
