NCT00253890

Insomnia and Drug Relapse Risk

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Butler Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Poor Quality Sleep
• Opiate Addiction

Interventions

Type	Name	Description
DRUG	Trazodone	50 mg 1-3 capsules at bedtime for 3 months
DRUG	Placebo	1-3 at bedtime

Timeline

• Start date: 2005-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2005-11-15
• Last updated: 2013-12-11
• Results posted: 2013-12-11

Locations

1 site across 1 country: United States