Insomnia and Drug Relapse Risk

Phase 3

Completed

• Conditions: Poor Quality Sleep; Opiate Addiction
• Interventions: Drug: Placebo; Drug: Trazodone

• Registration Number: NCT00253890
• Lead Sponsor: Butler Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2012-08-01
• Status Verified: 2013-10
• Results First Submitted QC: 2013-10-22
• Last Update Submitted: 2013-10-22
• Results First Posted: 2013-12-11
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1-3 capsules at bedtime for 90 days
Trazodone	Trazodone	50-150mg (50mg capsules) at bedtime for 90 days

Primary Outcome Measures

Name	Time	Method
Sleep Quality, as Measured by Total Sleep Time	Baseline to 1-month	Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States