Insomnia and Drug Relapse Risk

October 22, 2013 updated by: Michael Stein, MD, Butler Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trazodone
50-150mg (50mg capsules) at bedtime for 90 days
Drug: Trazodone
50 mg 1-3 capsules at bedtime for 3 months
Other Names:
  • Deprax
  • Desyrel
  • Oleptro
  • Beneficat
  • Desirel
  • Molipaxin
  • Thombran
  • Trazorel
  • Trialodine
  • Trittico
  • Mesyrel
Placebo Comparator: Placebo
1-3 capsules at bedtime for 90 days
Drug: Placebo
1-3 at bedtime
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality, as Measured by Total Sleep Time
Time Frame: Baseline to 1-month
Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.
Baseline to 1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Michael D Stein, MD, Rhode Island Hospital
  • Study Director: Rogers Griffith, MD, The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

October 22, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA020479 (U.S. NIH Grant/Contract)
  • R01DA020479-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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