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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00261183
First received: December 1, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  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-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided by Tel-Aviv Sourasky Medical Center

Additional 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
Study First Received: December 1, 2005
Last Updated: December 1, 2005
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on September 18, 2014