The Contribution of Melatonin Vs. Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients
- Conditions
- Benzodiazepines
- Registration Number
- NCT00261183
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief 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)
- Detailed 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Former opiates addicts, currently in methadone maintenance treatment, and abusing benzodiazepines who intend to withdrawal
- adults (>=18y)
- non abusing benzodiazepine
- Refuse making benzodiazepines withdrawal
- non methadone maintenance treatment patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Stop benzodiazepine abuse(Urine)
- Secondary Outcome Measures
Name Time Method sleep quality (self report- PSQI)
Trial Locations
- Locations (1)
Shaul Schreiber
🇮🇱Tel Aviv, Israel