Phase 3 Completed N=137 Randomized Quadruple-blind Treatment

Insomnia and Drug Relapse Risk

Poor Quality Sleep · Opiate Addiction

Source: ClinicalTrials.gov NCT00253890 ↗

Enrolled (actual)

137

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcomePrimary: Sleep Quality, as Measured by Total Sleep Time — 339; 329 minutes — p=.05

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Sleep Quality, as Measured by Total Sleep Time	339; 329	.05

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00253890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.