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

NCT00261183 | Unknown Phase 3

• 1 other identifier: TASMC-05-SS-03186-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Benzodiazepines

Outcome Measures

Primary Outcomes (1)

• Stop benzodiazepine abuse(Urine)

Secondary Outcomes (1)

• sleep quality (self report- PSQI)

Interventions

Melatonin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Former opiates addicts, currently in methadone maintenance treatment, and abusing benzodiazepines who intend to withdrawal
• adults (\>=18y)

You may not qualify if:

• non abusing benzodiazepine
• Refuse making benzodiazepines withdrawal
• non methadone maintenance treatment patients

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Shaul Schreiber

Tel Aviv, Israel

RECRUITING

Related Publications (2)

• Possemato K, Johnson EM, Emery JB, Wade M, Acosta MC, Marsch LA, Rosenblum A, Maisto SA. A pilot study comparing peer supported web-based CBT to self-managed web CBT for primary care veterans with PTSD and hazardous alcohol use. Psychiatr Rehabil J. 2019 Sep;42(3):305-313. doi: 10.1037/prj0000334. Epub 2018 Nov 29.

  PMID: 30489140 DERIVED

• Peles E, Hetzroni T, Bar-Hamburger R, Adelson M, Schreiber S. Melatonin for perceived sleep disturbances associated with benzodiazepine withdrawal among patients in methadone maintenance treatment: a double-blind randomized clinical trial. Addiction. 2007 Dec;102(12):1947-53. doi: 10.1111/j.1360-0443.2007.02007.x. Epub 2007 Oct 4.

  PMID: 17916225 DERIVED

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Shaul Schreiber, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Einat Peles, Ph.D.

CONTACT

97236973226; einatp@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 1, 2005
• First Posted: December 2, 2005
• Study Start: December 1, 2004
• Study Completion: December 1, 2006
• Last Updated: December 2, 2005

Record last verified: 2005-11

Locations

IL (1)