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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00261183
First Posted: December 2, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose
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)
  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00261183


Contacts
Contact: Einat Peles, Ph.D. 97236973226 einatp@tasmc.health.gov.il

Locations
Israel
Shaul Schreiber Recruiting
Tel Aviv, Israel
Contact: Shaul Schreiber, MD    97236973226    shaulsch@tasmc.health.gov.il   
Principal Investigator: Shaul Schreiber, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Shaul Schreiber, MD Tel Aviv Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00261183     History of Changes
Other Study ID Numbers: TASMC-05-SS-03186-CTIL
First Submitted: December 1, 2005
First Posted: December 2, 2005
Last Update Posted: December 9, 2005
Last Verified: November 2005

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