Phase 3
N=137
Insomnia and Drug Relapse Risk
Poor Quality Sleep · Opiate Addiction
Bottom Line
View on ClinicalTrials.gov: NCT00253890 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Sleep Quality, as Measured by Total Sleep Time — 339; 329 minutes — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Trazodone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Butler Hospital
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Quality, as Measured by Total Sleep Time |
339; 329 | .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.
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
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.