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Insomnia and Drug Relapse Risk

NCT00253890 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2013-12-11

Study results available
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Summary

The purposes of this study are:

1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and
2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.

Conditions

  • Poor Quality Sleep
  • Opiate Addiction

Interventions

DRUG

Trazodone

50 mg 1-3 capsules at bedtime for 3 months

DRUG

Placebo

1-3 at bedtime

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Butler Hospital

    lead OTHER

Principal Investigators

  • Michael D Stein, MD · Rhode Island Hospital

  • Rogers Griffith, MD · The Miriam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00253890 on ClinicalTrials.gov