CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 137 enrolled
Drug / intervention
Trazodone +1 moredrug
Likely dose
Trazodone 50 mg, 1–3 capsules at bedtimeAI-extracted
Key inclusion· 3
  • ✓Recent methadone maintenance enrollment
  • ✓Sleep complaints documented by Pittsburgh Sleep Quality Index (PSQI)
  • ✓No medical contraindications to trazodone
Key exclusion· 3
  • ✕Methadone maintenance enrollment not recent
  • ✕Absence of sleep complaints on Pittsburgh Sleep Quality Index (PSQI)
  • ✕Medical contraindications to trazodone

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00253890
NCT00253890Phase 3Completed
CompareCT.gov

Insomnia and Drug Relapse Risk

Butler Hospital·interventional·Posted Nov 15, 2005·Updated Dec 11, 2013

In Brief

A Phase 3 clinical trial evaluating Trazodone and Placebo for Poor Quality Sleep and Opiate Addiction. Completed, enrolled 137 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoor Quality Sleep, Opiate Addiction
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2005
Enrollment StartOct 1, 2005
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.6 years ago

Interventions

Trazodonedrug

50 mg 1-3 capsules at bedtime for 3 months

Placebodrug

1-3 at bedtime