Insomnia and Drug Relapse Risk - Full Text View

Sponsor:	Rhode Island Hospital
Information provided by:	Rhode Island Hospital
ClinicalTrials.gov Identifier:	NCT00253890

Purpose

The purposes of this study are:

to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and
to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.

Condition	Intervention	Phase
Sleep Quality Methadone Maintenance	Drug: Trazodone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Insomnia and Drug Relapse Risk

Resource links provided by NLM:

Drug Information available for: Trazodone Trazodone hydrochloride

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:

sleep quality [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
methadone maintenance [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

substance use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	172
Study Start Date:	October 2005
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

50 mg 1-3 capsules at bedtime for 3 months

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253890

Contacts

Contact: Michael D Stein, MD	401-455-6646	mstein@butler.org
Contact: Megan Kurth, MPH	401-455-6653	mkurth@butler.org

Locations

United States, Rhode Island
Butler Hospital	Recruiting
Providence, Rhode Island, United States, 02906
Contact: Megan Kurth, MPH 401-455-6653 mkurth@butler.org
Principal Investigator: Michael D Stein, MD

Sponsors and Collaborators

Rhode Island Hospital

Investigators

Principal Investigator:	Michael D Stein, MD	Rhode Island Hospital
Study Director:	Rogers Griffith, MD	The Miriam Hospital

More Information

No publications provided

Responsible Party:	Butler Hospital ( Michael D. Stein, MD )
Study ID Numbers:	RO1 DA 020479, 2073-05
Study First Received:	November 10, 2005
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00253890 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:

sleep quality
methadone
substance use

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Trazodone
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2009