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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00261183
Enrollment
100
Registered
2005-12-02
Start date
2004-12-31
Completion date
2006-12-31
Last updated
2005-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benzodiazepines

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)

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)

Interventions

DRUGMelatonin

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Stop benzodiazepine abuse(Urine)

Secondary

MeasureTime frame
sleep quality (self report- PSQI)

Countries

Israel

Contacts

Primary ContactEinat Peles, Ph.D.
einatp@tasmc.health.gov.il97236973226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026