Insomnia and Drug Relapse Risk

Condition(s) targeted: Sleep Quality; Methadone Maintenance

Intervention: Trazodone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Rhode Island Hospital

Official(s) and/or principal investigator(s):
Michael D Stein, MD, Principal Investigator, Affiliation: Rhode Island Hospital
Rogers Griffith, MD, Study Director, Affiliation: The Miriam Hospital

Overall contact:
Michael D Stein, MD, Phone: 401-444-3830, Email: mstein@lifespan.org

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.

Official title: Insomnia and Drug Relapse Risk

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

sleep quality

methadone maintenance

Secondary outcome: substance use

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Michael D Stein, MD, Phone: 401-444-3830, Email: mstein@lifespan.org

Rhode Island Hospital, Providence, Rhode Island 02903, United States; Recruiting
Megan Kurth, MPH, Phone: 401-444-0799, Email: mkurth@lifespan.org
Michael D Stein, MD, Principal Investigator

Starting date: October 2005
Ending date: April 2010
Last updated: December 17, 2007