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A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Naltrexone in Outpatients With Bipolar Disorder and Alcohol Dependence

Authors

  • E. Sherwood Brown,

    1. From the Department of Psychiatry (ESB, RC, BA) and Department of Clinical Sciences (TJC), The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; Department of Psychiatry (JMS, ACS), The University of Texas Medical School at Houston, Houston, Texas; Dallas Regional Campus (RC) and VA North Texas Health Care Center (BA), The University of Texas School of Public Health, Dallas, Texas; Duke-NUS Graduate Medical School (AJR), Singapore.
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  • Thomas J. Carmody,

    1. From the Department of Psychiatry (ESB, RC, BA) and Department of Clinical Sciences (TJC), The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; Department of Psychiatry (JMS, ACS), The University of Texas Medical School at Houston, Houston, Texas; Dallas Regional Campus (RC) and VA North Texas Health Care Center (BA), The University of Texas School of Public Health, Dallas, Texas; Duke-NUS Graduate Medical School (AJR), Singapore.
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  • Joy M. Schmitz,

    1. From the Department of Psychiatry (ESB, RC, BA) and Department of Clinical Sciences (TJC), The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; Department of Psychiatry (JMS, ACS), The University of Texas Medical School at Houston, Houston, Texas; Dallas Regional Campus (RC) and VA North Texas Health Care Center (BA), The University of Texas School of Public Health, Dallas, Texas; Duke-NUS Graduate Medical School (AJR), Singapore.
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  • Raul Caetano,

    1. From the Department of Psychiatry (ESB, RC, BA) and Department of Clinical Sciences (TJC), The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; Department of Psychiatry (JMS, ACS), The University of Texas Medical School at Houston, Houston, Texas; Dallas Regional Campus (RC) and VA North Texas Health Care Center (BA), The University of Texas School of Public Health, Dallas, Texas; Duke-NUS Graduate Medical School (AJR), Singapore.
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  • Bryon Adinoff,

    1. From the Department of Psychiatry (ESB, RC, BA) and Department of Clinical Sciences (TJC), The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; Department of Psychiatry (JMS, ACS), The University of Texas Medical School at Houston, Houston, Texas; Dallas Regional Campus (RC) and VA North Texas Health Care Center (BA), The University of Texas School of Public Health, Dallas, Texas; Duke-NUS Graduate Medical School (AJR), Singapore.
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  • Alan C. Swann,

    1. From the Department of Psychiatry (ESB, RC, BA) and Department of Clinical Sciences (TJC), The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; Department of Psychiatry (JMS, ACS), The University of Texas Medical School at Houston, Houston, Texas; Dallas Regional Campus (RC) and VA North Texas Health Care Center (BA), The University of Texas School of Public Health, Dallas, Texas; Duke-NUS Graduate Medical School (AJR), Singapore.
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  • A. John Rush

    1. From the Department of Psychiatry (ESB, RC, BA) and Department of Clinical Sciences (TJC), The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; Department of Psychiatry (JMS, ACS), The University of Texas Medical School at Houston, Houston, Texas; Dallas Regional Campus (RC) and VA North Texas Health Care Center (BA), The University of Texas School of Public Health, Dallas, Texas; Duke-NUS Graduate Medical School (AJR), Singapore.
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Reprint requests: E. Sherwood Brown, MD, PhD, Department of Psychiatry, UT Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., Dallas, TX 75390-8849; Fax: 214-645-6951; E-mail: sherwood.brown@utsouthwestern.edu

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.

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