NCT04003948

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

Preliminar Efficacy and Safety of Ibogaine in the Treatment of Methadone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: International Center for Ethnobotanical Education, Research, and Service · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Dependence
• Drug Use Disorders
• Opioid Dependence

Interventions

Type	Name	Description
DRUG	Ibogaine Hydrochloride	Fixed or ascending doses of ibogaine will be administered for the treatment of opioid withdrawal syndrome.

Timeline

• Start date: 2020-10-28
• Primary completion: 2024-04-26
• Completion: 2024-04-26
• First posted: 2019-07-01
• Last updated: 2025-01-17

Locations

1 site across 1 country: Spain