Insomnia and Drug Relapse Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00253890
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : December 11, 2013
Last Update Posted : December 11, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

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.

Condition or disease Intervention/treatment Phase
Poor Quality Sleep Opiate Addiction Drug: Trazodone Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Insomnia and Drug Relapse Risk
Study Start Date : October 2005
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Trazodone
50-150mg (50mg capsules) at bedtime for 90 days
Drug: Trazodone
50 mg 1-3 capsules at bedtime for 3 months
Other Names:
  • Desyrel
  • Oleptro
  • Beneficat
  • Deprax
  • Desirel
  • Molipaxin
  • Thombran
  • Trazorel
  • Trialodine
  • Trittico
  • Mesyrel
Placebo Comparator: Placebo
1-3 capsules at bedtime for 90 days
Drug: Placebo
1-3 at bedtime
Other Name: Sugar pill

Primary Outcome Measures :
  1. Sleep Quality, as Measured by Total Sleep Time [ Time Frame: Baseline to 1-month ]
    Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00253890

United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Michael D Stein, MD Rhode Island Hospital
Study Director: Rogers Griffith, MD The Miriam Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Stein, MD, Director, General Medicine Research, Butler Hospital Identifier: NCT00253890     History of Changes
Other Study ID Numbers: R01DA020479 ( U.S. NIH Grant/Contract )
R01DA020479-01 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2005    Key Record Dates
Results First Posted: December 11, 2013
Last Update Posted: December 11, 2013
Last Verified: October 2013

Keywords provided by Michael Stein, MD, Butler Hospital:
sleep quality
substance use

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents