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

NCT ID: NCT00261183

Last Updated: 2005-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-12-31

Brief Summary

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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)

Detailed Description

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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)

Conditions

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Benzodiazepines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Melatonin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Shaul Schreiber, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

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Shaul Schreiber

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Einat Peles, Ph.D.

Role: CONTACT

Phone: 97236973226

Email: [email protected]

Facility Contacts

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Shaul Schreiber, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 30489140 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17916225 (View on PubMed)

Other Identifiers

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TASMC-05-SS-03186-CTIL

Identifier Type: -

Identifier Source: org_study_id