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Insomnia and Drug Relapse Risk

Information source: Butler Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Poor Quality Sleep; Opiate Addiction

Intervention: Trazodone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Butler 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


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.

Clinical Details

Official title: Insomnia and Drug Relapse Risk

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Sleep Quality, as Measured by Total Sleep Time

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.


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

Locations and Contacts

Butler Hospital, Providence, Rhode Island 02906, United States
Additional Information

Starting date: October 2005
Last updated: October 22, 2013

Page last updated: August 23, 2015

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