drugset / Trial / NCT00261183

The Contribution of Melatonin Vs. Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients

NCT00261183

Phase 3 Unknown 100 enrolled Tel-Aviv Sourasky Medical Center
RandomizedCrossoverDouble-blindTreatment

Summary

We hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin to solve sleep-problems which commonly occur during benzodiazepine withdrawal. Former heroin addicts, currently in Methadone maintenance treatment, who are also abusing benzodiazepine, started self benzodiazepine withdrawal, and got for 6 weeks melatonin (5mg/day, taken every night) or placebo and after 1 week, additional 6 weeks with placebo or melatonin (double blind for what got first).Success The benzodiazepine withdrawal success was evaluated by urine for benzodiazepines, and sleep quality was evaluated using PSQI questionnaire (baseline,and after weeks 6, 7, 13)

Timeline

Start
2004-12
Primary completion
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 5 mg

Indications

No indication recorded.