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 III

Further study details as provided by Rhode Island Hospital:

Primary Outcomes: sleep quality; methadone maintenance
Secondary Outcomes: substance use
Expected Total Enrollment:  172

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• recent methadone maintenance enrollment
• sleep complaints as measured by the PSQI
• no medical contraindications to Trazodone

Exclusion Criteria:

• methadone maintenance enrollment not recent
• no sleep complaints as measured by the PSQI
• no medical contraindications to Trazodone

Please refer to this study by ClinicalTrials.gov identifier  NCT00253890

Michael D Stein, MD      401-444-3830    mstein@lifespan.org
Megan Kurth, MPH      401-444-2308    mkurth@lifespan.org

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States

Study chairs or principal investigators

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

Study ID Numbers:  RO1 DA 020479; 2073-05
Last Updated:  December 8, 2005
Record first received:  November 10, 2005
ClinicalTrials.gov Identifier:  NCT00253890
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10