A randomized, double-blind, placebo-controlled pilot study of naltrexone in outpatients with bipolar disorder and alcohol dependence

E. Sherwood Brown, Thomas J. Carmody, Joy M. Schmitz, Raul Caetano, Bryon Adinoff, Alan C. Swann, A. John Rush

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

Background: Alcohol dependence is extremely common in patients with bipolar disorder and is associated with unfavorable outcomes including treatment nonadherence, violence, increased hospitalization, and decreased quality of life. While naltrexone is a standard treatment for alcohol dependence, no controlled trials have examined its use in patients with co-morbid bipolar disorder and alcohol dependence. In this pilot study, the efficacy of naltrexone in reducing alcohol use and on mood symptoms was assessed in bipolar disorder and alcohol dependence. Methods: Fifty adult outpatients with bipolar I or II disorders and current alcohol dependence with active alcohol use were randomized to 12 weeks of naltrexone (50 mg/d) add-on therapy or placebo. Both groups received manual-driven cognitive behavioral therapy designed for patients with bipolar disorder and substance-use disorders. Drinking days and heavy drinking days, alcohol craving, liver enzymes, and manic and depressed mood symptoms were assessed. Results: The 2 groups were similar in baseline and demographic characteristics. Naltrexone showed trends (p < 0.10) toward a greater decrease in drinking days (binary outcome), alcohol craving, and some liver enzyme levels than placebo. Side effects were similar in the 2 groups. Response to naltrexone was significantly related to medication adherence. Conclusions: Results suggest the potential value and acceptable tolerability of naltrexone for alcohol dependence in bipolar disorder patients. A larger trial is needed to establish efficacy.

Original languageEnglish (US)
Pages (from-to)1863-1869
Number of pages7
JournalAlcoholism: Clinical and Experimental Research
Volume33
Issue number11
DOIs
StatePublished - Nov 2009

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Naltrexone
Bipolar Disorder
Alcoholism
Outpatients
Placebos
Alcohols
Drinking
Medication Adherence
Liver
Cognitive Therapy
Enzymes
Violence
Alcohol Drinking
Substance-Related Disorders
Hospitalization
Quality of Life
Demography
Therapeutics

Keywords

  • Alcohol
  • Bipolar Disorder
  • Depression
  • Mania
  • Naltrexone

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Psychiatry and Mental health
  • Toxicology

Cite this

A randomized, double-blind, placebo-controlled pilot study of naltrexone in outpatients with bipolar disorder and alcohol dependence. / Brown, E. Sherwood; Carmody, Thomas J.; Schmitz, Joy M.; Caetano, Raul; Adinoff, Bryon; Swann, Alan C.; Rush, A. John.

In: Alcoholism: Clinical and Experimental Research, Vol. 33, No. 11, 11.2009, p. 1863-1869.

Research output: Contribution to journalArticle

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