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Insomnia and Drug Relapse Risk

This study has been completed.
Sponsor:
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00253890
First received: November 10, 2005
Last updated: August 1, 2011
Last verified: August 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Sleep Quality
Methadone Maintenance
 Drug: Trazodone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Insomnia and Drug Relapse Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • sleep quality [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • methadone maintenance [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • substance use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: October 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trazodone Drug: Trazodone
50 mg 1-3 capsules at bedtime for 3 months

Detailed Description:

Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent methadone maintenance enrollment
  • Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)
  • No medical contraindications to trazodone

Exclusion Criteria:

  • Methadone maintenance enrollment not recent
  • No sleep complaints as measured by the PSQI
  • Medical contraindications to trazodone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253890

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Michael D Stein, MD Rhode Island Hospital
Study Director: Rogers Griffith, MD The Miriam Hospital
  More Information

No publications provided by Butler Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael D. Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier: NCT00253890     History of Changes
Other Study ID Numbers: RO1 DA 020479, 2073-05
Study First Received: November 10, 2005
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Butler Hospital:
sleep quality
methadone
substance use

Additional relevant MeSH terms:
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on May 23, 2013