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

Benzodiazepines Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00261183
• Other study ID #: TASMC-05-SS-03186-CTIL
• Status: Recruiting
• Phase: Phase 3
• First received: December 1, 2005
• Last updated: December 1, 2005
• Start date: December 2004
• Est. completion date: December 2006

Study information

• Verified date: November 2005
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Einat Peles, Ph.D.
• Phone: 97236973226
• Email: einatp[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

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)

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Benzodiazepines

Intervention

Drug:
• Melatonin

Locations

Country	Name	City	State
Israel	Shaul Schreiber	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stop benzodiazepine abuse(Urine)
Secondary	sleep quality (self report- PSQI)