Trazodone for sleep disturbance during methadone maintenance: A double-blind, placebo-controlled trial.
Author(s): Stein MD, Kurth ME, Sharkey KM, Anderson BJ, Corso RP, Millman RP
Affiliation(s): Department of Medicine, Alpert Medical School of Brown University, Box G, Providence, RI 02912, USA; Department of Community Health, Alpert Medical School of Medicine of Brown University, Box G, Providence, RI 02912, USA; General Medicine Research Unit, Butler Hospital, 345 Blackstone Boulevard, Providence, RI 02906, USA.
Publication date & source: 2011-07-26, Drug Alcohol Depend., [Epub ahead of print]
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. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.