Insomnia and Drug Relapse Risk - Full Text View

Sponsor:	Butler Hospital
Information provided by:	Butler 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Butler 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 ]

Enrollment:	137
Study Start Date:	October 2005
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Trazodone	Drug: Trazodone 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

Locations

United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Butler Hospital

Investigators

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

More Information

No publications provided by Butler Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Michael D. Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:	NCT00253890 History of Changes
Other Study ID Numbers:	RO1 DA 020479, 2073-05
Study First Received:	November 10, 2005
Last Updated:	August 1, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Butler Hospital:

sleep quality
methadone
substance use

Additional relevant MeSH terms:

Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on February 12, 2012