Insomnia and Drug Relapse Risk

Study Overview
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Brief Summary
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The purposes of this study are: to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.

Detailed Description
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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.

Official Title
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Insomnia and Drug Relapse Risk

Conditions
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Poor Quality Sleep, Opiate Addiction

Intervention / Treatment
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* Drug: Trazodone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trazodone<br>50-150mg (50mg capsules) at bedtime for 90 days | Drug: Trazodone<br>* 50 mg 1-3 capsules at bedtime for 3 months<br>* Other names: Mesyrel;|
| Placebo Comparator: Placebo<br>1-3 capsules at bedtime for 90 days | Drug: Placebo<br>* 1-3 at bedtime<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality, as Measured by Total Sleep Time | Number of minutes spent sleeping during sleep period, as measured by daily sleep diary. | Baseline to 1-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep quality, methadone, substance use