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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 3

Conditions: Benzodiazepines

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT00261183

TASMC-05-SS-03186-CTIL

Details and patient eligibility

About

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)

Full 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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Former opiates addicts, currently in methadone maintenance treatment, and abusing benzodiazepines who intend to withdrawal
• adults (>=18y)

Exclusion criteria

• non abusing benzodiazepine
• Refuse making benzodiazepines withdrawal
• non methadone maintenance treatment patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind