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OpenTrials
Completed

NCT Number: NCT00253890

Insomnia and Drug Relapse Risk

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.

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Key information

Conditions

Poor Quality Sleep Chemically-Induced Disorders Dyssomnias Mental Disorders Narcotic-Related Disorders Nervous System Diseases Opiate Addiction Opioid-Related Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trazodone

Drug

50 mg 1-3 capsules at bedtime for 3 months

Other names: Desyrel, Oleptro, Beneficat, Deprax, Desirel, Molipaxin, Thombran, Trazorel, Trialodine, Trittico, Mesyrel

Placebo

Drug

1-3 at bedtime

Other names: Sugar pill

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Nov 15, 2005
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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