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

Benzodiazepines Clinical Trial

Status Recruiting

Clinical Trial 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)

Clinical Trial Description

A total of 100 patients will participate. Follow-up of benzodiazepines in urine after study and 6 months later will be evaluated, as well as sleep quality (using PSQI) ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benzodiazepines

• NCT number: NCT00261183
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Einat Peles, Ph.D.
• Phone: 97236973226
• Email: einatp@tasmc.health.gov.il
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2004
• Completion date: December 2006