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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261183
Recruitment Status : Unknown
Verified November 2005 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : December 2, 2005
Last Update Posted : December 2, 2005
Information provided by:
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)

Condition or disease Intervention/treatment Phase
Benzodiazepines Drug: Melatonin Phase 3

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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : December 2004
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Primary Outcome Measures :
  1. Stop benzodiazepine abuse(Urine)

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00261183     History of Changes
Other Study ID Numbers: TASMC-05-SS-03186-CTIL
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: December 2, 2005
Last Verified: November 2005

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants