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

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.

Topic Addiction Opioid Use Disorder
Compound Ibogaine Placebo
Country Spain
Visit trial
Status Recruiting
Results Published No
Start date 28 October 2020
End date 15 September 2022
Chance of happening 100%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 60
Therapy No

Trial Details

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.

NCT Number NCT04003948

Sponsors & Collaborators

MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

University Rovira i Virgili
Located in Tarragona, Spain. Researchers at the university are taking part in a large clinical trial in Spain that is exploring the use of ibogaine in methadone detoxification.

Universidad Autonoma de Madrid
Universidad Autonoma de Madrid is one research institution collaborating on an upcoming clinical trial with ibogaine in Spain.

Hospital Universitari Sant Joan de Reus
This company doesn't have a full profile yet, it is linked to a clinical trial.

University of São Paulo
The University of São Paulo has been conducting research with psychedelics for many years, with a focus on ayahuasca given its traditional use in Brazil.

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