Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification
Status:
Recruiting
Trial end date:
2022-09-15
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
International Center for Ethnobotanical Education, Research, and Service
Collaborators:
Hospital Universitari Sant Joan de Reus Multidisciplinary Association for Psychedelic Studies Universidad Autonoma de Madrid University of Sao Paulo University Rovira i Virgili