Insomnia and Drug Relapse Risk

Butler Hospital

Status and phase: Completed; Phase 3

Conditions: Opiate Addiction; Poor Quality Sleep

Treatments: Drug: Placebo; Drug: Trazodone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00253890

R01DA020479

R01DA020479-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 2 patient groups, including a placebo group

Trazodone

Active Comparator group

Description:

50-150mg (50mg capsules) at bedtime for 90 days

Treatment:

Drug: Trazodone

Placebo

Placebo Comparator group

Description:

1-3 capsules at bedtime for 90 days

Treatment:

Drug: Placebo