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Original Investigation
August 7, 2013

Concurrent Naltrexone and Prolonged Exposure Therapy for Patients With Comorbid Alcohol Dependence and PTSD: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Psychiatry, University of Pennsylvania, Philadelphia
  • 2Department of Psychology, University of Suffolk, Boston, Massachusetts
  • 3Department of Psychiatry, Montefiore Medical Center, Bronx, New York
  • 4VISN 4 Mental Illness Research Education and Clinical Center, Veterans Administration, Philadelphia, Pennsylvania
  • 5Department of Medical and Clinical Psychology, Uniformed Services University, Bethesda, Maryland
  • 6Institute of Addiction Medicine, Plymouth Meeting, Pennsylvania
  • 7Department of Psychiatry, Temple University, Philadelphia, Pennsylvania
JAMA. 2013;310(5):488-495. doi:10.1001/jama.2013.8268
Abstract

Importance  Alcohol dependence comorbid with posttraumatic stress disorder (PTSD) has been found to be resistant to treatment. In addition, there is a concern that prolonged exposure therapy for PTSD may exacerbate alcohol use.

Objective  To compare the efficacy of an evidence-based treatment for alcohol dependence (naltrexone) plus an evidence-based treatment for PTSD (prolonged exposure therapy), their combination, and supportive counseling.

Design, Setting, and Participants  A single-blind, randomized clinical trial of 165 participants with PTSD and alcohol dependence conducted at the University of Pennsylvania and the Philadelphia Veterans Administration. Participant enrollment began on February 8, 2001, and ended on June 25, 2009. Data collection was completed on August 12, 2010.

Interventions  Participants were randomly assigned to (1) prolonged exposure therapy plus naltrexone (100 mg/d), (2) prolonged exposure therapy plus pill placebo, (3) supportive counseling plus naltrexone (100 mg/d), or (4) supportive counseling plus pill placebo. Prolonged exposure therapy was composed of 12 weekly 90-minute sessions followed by 6 biweekly sessions. All participants received supportive counseling.

Main Outcomes and Measures  The Timeline Follow-Back Interview and the PTSD Symptom Severity Interview were used to assess the percentage of days drinking alcohol and PTSD severity, respectively, and the Penn Alcohol Craving Scale was used to assess alcohol craving. Independent evaluations occurred prior to treatment (week 0), at posttreatment (week 24), and at 6 months after treatment discontinuation (week 52).

Results  Participants in all 4 treatment groups had large reductions in the percentage of days drinking (mean change, −63.9% [95% CI, −73.6% to −54.2%] for prolonged exposure therapy plus naltrexone; −63.9% [95% CI, −73.9% to −53.8%] for prolonged exposure therapy plus placebo; −69.9% [95% CI, −78.7% to −61.2%] for supportive counseling plus naltrexone; and −61.0% [95% CI, −68.9% to −53.0%] for supportive counseling plus placebo). However, those who received naltrexone had lower percentages of days drinking than those who received placebo (mean difference, 7.93%; P = .008). There was also a reduction in PTSD symptoms in all 4 groups, but the main effect of prolonged exposure therapy was not statistically significant. Six months after the end of treatment, participants in all 4 groups had increases in percentage of days drinking. However, those in the prolonged exposure therapy plus naltrexone group had the smallest increases.

Conclusions and Relevance  In this study of patients with alcohol dependence and PTSD, naltrexone treatment resulted in a decrease in the percentage of days drinking. Prolonged exposure therapy was not associated with an exacerbation of alcohol use disorder.

Trial Registration  clinicaltrials.gov Identifier: NCT00006489

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