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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2005 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: December 1, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
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)

Condition Intervention Phase
Benzodiazepines Drug: Melatonin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Stop benzodiazepine abuse(Urine)

Secondary Outcome Measures:
  • sleep quality (self report- PSQI)

Estimated Enrollment: 100
Study Start Date: December 2004
Estimated Study Completion Date: December 2006
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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00261183

Contact: Einat Peles, Ph.D. 97236973226

Shaul Schreiber Recruiting
Tel Aviv, Israel
Contact: Shaul Schreiber, MD    97236973226   
Principal Investigator: Shaul Schreiber, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Shaul Schreiber, MD Tel Aviv Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00261183     History of Changes
Other Study ID Numbers: TASMC-05-SS-03186-CTIL
Study First Received: December 1, 2005
Last Updated: December 1, 2005

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants processed this record on August 17, 2017