Patients in early recovery from alcohol dependence 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 after alcohol detoxification. Because poor sleep is a """"""""high risk situation,"""""""" can lead to drinking to relieve insomnia, is associated with negative affective states, and might impair the ability to cope with urges to drink, this proposal's aims are: 1. To determine whether bedtime treatment with low-dose trazodone reduces recurrent drinking among sleep-disturbed alcohol dependent subjects in early recovery. Process analyses will examine whether trazodone has greater efficacy in subjects with certain attributes, such as worse global sleep quality, fatigue or depressive symptoms, and whether changes in these attributes mediate trazodone's effect on recurrent drinking. 2. To explore whether trazodone is associated with differences in sleep architecture, and whether these differences are associated with improved sleep quality and reductions in recurrent drinking. To accomplish these aims, we propose a randomized, double-blind trial of low-dose trazodone versus identical placebo at bedtime for 12-weeks in 266 sleep-disturbed alcohol dependent subjects who will be enrolled 5-7 days after inpatient detoxification. Both groups will receive a booklet on basic sleep hygiene. Urn randomization will ensure balance by depressive symptoms, homelessness, and gender. Subjects will receive follow-up interviews 4-, 12-, and 24-weeks later, with biomarker confirmation of self-reported alcohol consumption. Latent growth analysis will examine whether trazodone increases the subsequent percentage of days abstinent and drinks per drinking day. Our research team is highly experienced in alcohol research, sleep disorders, and clinical trials in substance-abusing populations. Our extensive contacts with community agencies and substance abuse treatment facilities should enhance follow-up rates.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Project (R01)
Project #
5R01AA013243-03
Application #
6641282
Study Section
Special Emphasis Panel (ZAA1-BB (03))
Program Officer
Fertig, Joanne
Project Start
2001-09-27
Project End
2005-07-31
Budget Start
2003-08-01
Budget End
2004-07-31
Support Year
3
Fiscal Year
2003
Total Cost
$503,002
Indirect Cost
Name
Rhode Island Hospital (Providence, RI)
Department
Type
DUNS #
075710996
City
Providence
State
RI
Country
United States
Zip Code
02903
Friedmann, Peter D; Rose, Jennifer S; Swift, Robert et al. (2008) Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial. Alcohol Clin Exp Res 32:1652-60
Stein, Michael D; Friedmann, Peter D (2005) Disturbed sleep and its relationship to alcohol use. Subst Abus 26:1-13
Friedmann, Peter D; Herman, Debra S; Freedman, Shelby et al. (2003) Treatment of sleep disturbance in alcohol recovery: a national survey of addiction medicine physicians. J Addict Dis 22:91-103