title: Trazodone for sleep disturbance during methadone maintenance: a double-blind, placebo-controlled trial.
abstract: BACKGROUND
  To test whether trazodone, one of the most commonly prescribed medications for treatment of insomnia, improves subjective and/or objective sleep among methadone-maintained persons with sleep complaints, we performed a randomized, double-blind, placebo-controlled trial with 6-month follow-up.
  
  
  METHODS
  From eight methadone maintenance programs in the northeastern United States, we recruited 137 persons receiving methadone for at least 1 month who reported a Pittsburgh Sleep Quality Index (PSQI) score of six or higher. Two-night home polysomnography (PSG) was completed at baseline and 1 month later, with morning surveys and urine drug toxicologies. Interviews assessed sleep over the past 30 days at baseline and 1-, 3-, and 6-month follow-ups.
  
  
  RESULTS
  Participants averaged 38 years of age, were 47% male, and had a mean PSQI total score of 12.9 (±3.1). At baseline, intervention groups did not significantly differ on 10 PSG-derived objective sleep measures and 11 self-reported measures. Over 88% (n=121) of participants completed the PSG at 1-month. Without adjusting p-values for multiple comparisons, only 1 of 21 sleep measure comparisons was statistically significant (p<.05). The effect of trazodone on mean PSQI scores during the 6-month follow-up was not statistically significant (p=.10). Trazodone neither significantly increased nor decreased illicit drug use relative to placebo.
  
  
  CONCLUSIONS
  Trazodone did not improve subjective or objective sleep in methadone-maintained persons with sleep disturbance. Other pharmacologic and non-pharmacologic treatments should be investigated for this population with high rates of insomnia.
authors.affiliation: Department of Medicine, Alpert Medical School of Brown University, Box G, Providence, RI 02912, USA. michael stein@brown.edu
authors.forename: Michael D
authors.initials: MD
authors.lastname: Stein
authors.forename: Megan E
authors.initials: ME
authors.lastname: Kurth
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Sharkey
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Anderson
authors.forename: Richard P
authors.initials: RP
authors.lastname: Corso
authors.forename: Richard P
authors.initials: RP
authors.lastname: Millman
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008297:Male; D008691:Methadone / Q000009:adverse effects / Q000627:therapeutic use*; D009294:Narcotics / Q000009:adverse effects / Q000627:therapeutic use*; D058850:Opiate Substitution Treatment / Q000009:adverse effects*; D017286:Polysomnography; D012893:Sleep Wake Disorders / Q000139:chemically induced / Q000188:drug therapy*; D014196:Trazodone / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D006993:Hypnotics and Sedatives; D009294:Narcotics; D008691:Methadone; D014196:Trazodone