Insomnia and Drug Relapse Risk
2 other identifiers
interventional
137
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2005
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
December 11, 2013
CompletedDecember 11, 2013
October 1, 2013
4.6 years
November 10, 2005
August 1, 2012
October 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Trazodone
ACTIVE COMPARATOR50-150mg (50mg capsules) at bedtime for 90 days
Placebo
PLACEBO COMPARATOR1-3 capsules at bedtime for 90 days
Interventions
Eligibility Criteria
You may qualify if:
- Recent methadone maintenance enrollment
- Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)
- No medical contraindications to trazodone
You may not qualify if:
- Methadone maintenance enrollment not recent
- No sleep complaints as measured by the PSQI
- Medical contraindications to trazodone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Butler Hospital
Providence, Rhode Island, 02906, United States
Related Publications (1)
Kurth ME, Sharkey KM, Millman RP, Corso RP, Stein MD. Insomnia among methadone-maintained individuals: the feasibility of collecting home polysomnographic recordings. J Addict Dis. 2009 Jul;28(3):219-25. doi: 10.1080/10550880903014155.
PMID: 20155590DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael D. Stein, MD
- Organization
- Butler Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Michael D Stein, MD
Rhode Island Hospital
- STUDY DIRECTOR
Rogers Griffith, MD
The Miriam Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, General Medicine Research
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 15, 2005
Study Start
October 1, 2005
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
December 11, 2013
Results First Posted
December 11, 2013
Record last verified: 2013-10