Patients initiating methadone maintenance treatment (MMT) commonly experience poor sleep, but evidence supporting pharmacological treatment of their sleep disturbance is lacking. Trazodone, an F.D.A.-approved sedating antidepressant, is one of the most commonly prescribed medications for insomnia nationwide and the most commonly prescribed medication for sleep disturbance among drug dependent persons. We will use a laboratory measure of sleep, polysomnography, to improve our understanding of the relationship of basic sleep physiology to drug abuse relapse. Because poor sleep is a """"""""high risk situation,"""""""" can lead to drug use to relieve insomnia, is associated with negative affective states, and might impair the ability to cope with urges to use drugs, this proposal's Primary Aim is: To determine whether bedtime treatment with low-dose trazodone reduces drug relapse among sleep-disturbed opiate dependent persons initiating MMT. Secondary Aims are to explore whether trazodone has greater efficacy in subjects with certain attributes, such as worse sleep quality, fatigue or depressive symptoms, and whether changes in these attributes mediate trazodone's effect on drug relapse; to explore whether trazodone is associated with differences in sleep architecture compared to placebo, and whether these differences are associated with improved sleep quality and fatigue, and reductions in relapse; to explore polysomnographic predictors of drug relapse; and to explore the polysomnographic correlates of subjective sleep complaints. To accomplish these aims, we propose a randomized, double-blind trial of low-dose trazodone versus identical placebo at bedtime for 12- weeks in 172 sleep-disturbed MMT patients. Both groups will receive a booklet on basic sleep hygiene. Urn randomization will ensure balance by depressive symptoms, gender, and MMT duration. Subjects will receive follow-up interviews 4-, 12-, and 24-weeks later, with toxicological confirmation of self-reported drug use. Two-night sleep studies will be performed in subjects' homes at baseline and 4 weeks later. Our research team is highly experienced in drug research, sleep disorders, and clinical trials in substance abusing populations.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
7R01DA020479-04
Application #
7491804
Study Section
Special Emphasis Panel (ZDA1-RXL-E (15))
Program Officer
Gordon, Harold
Project Start
2005-09-30
Project End
2010-08-31
Budget Start
2008-09-01
Budget End
2009-08-31
Support Year
4
Fiscal Year
2008
Total Cost
$293,353
Indirect Cost
Name
Butler Hospital (Providence, RI)
Department
Type
DUNS #
069847804
City
Providence
State
RI
Country
United States
Zip Code
02906
Stein, Michael D; Kurth, Megan E; Sharkey, Katherine M et al. (2012) Trazodone for sleep disturbance during methadone maintenance: a double-blind, placebo-controlled trial. Drug Alcohol Depend 120:65-73
Sharkey, Katherine M; Kurth, Megan E; Anderson, Bradley J et al. (2011) Assessing sleep in opioid dependence: a comparison of subjective ratings, sleep diaries, and home polysomnography in methadone maintenance patients. Drug Alcohol Depend 113:245-8
Sharkey, Katherine M; Kurth, Megan E; Anderson, Bradley J et al. (2010) Obstructive sleep apnea is more common than central sleep apnea in methadone maintenance patients with subjective sleep complaints. Drug Alcohol Depend 108:77-83
Kurth, Megan E; Sharkey, Katherine M; Millman, Richard P et al. (2009) Insomnia among methadone-maintained individuals: the feasibility of collecting home polysomnographic recordings. J Addict Dis 28:219-25
Sharkey, Katherine M; Kurth, Megan E; Corso, Richard P et al. (2009) Home polysomnography in methadone maintenance patients with subjective sleep complaints. Am J Drug Alcohol Abuse 35:178-82