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.
