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Randomized Controlled Trial
. 2008 Jul;32(7):1299-308.
doi: 10.1111/j.1530-0277.2008.00698.x.

A placebo-controlled randomized clinical trial of naltrexone in the context of different levels of psychosocial intervention

David W Oslin  1 , Kevin G Lynch, Helen M Pettinati, Kyle M Kampman, Peter Gariti, Lois Gelfand, Thomas Ten Have, Shoshana Wortman, William Dundon, Charles Dackis, Joseph R Volpicelli, Charles P O'Brien
Affiliations
Randomized Controlled Trial

A placebo-controlled randomized clinical trial of naltrexone in the context of different levels of psychosocial intervention

David W Oslin et al. Alcohol Clin Exp Res. 2008 Jul.

Abstract

Background: Naltrexone is approved for the treatment of alcohol dependence when used in conjunction with a psychosocial intervention. This study was undertaken to examine the impact of 3 types of psychosocial treatment combined with either naltrexone or placebo treatment on alcohol dependency over 24 weeks of treatment: (1) Cognitive-Behavioral Therapy (CBT) + medication clinic, (2) BRENDA (an intervention promoting pharmacotherapy) + medication clinic, and (3) a medication clinic model with limited therapeutic content.

Methods: Two hundred and forty alcohol-dependent subjects were enrolled in a 24-week double-blind placebo-controlled study of naltrexone (100 mg/d). Subjects were also randomly assigned to 1 of 3 psychosocial interventions. All patients were assessed for alcohol use, medication adherence, and adverse events at regularly scheduled research visits.

Results: There was a modest main treatment effect for the psychosocial condition favoring those subjects randomized to CBT. Intent-to-treat analyses suggested that there was no overall efficacy of naltrexone and no medication by psychosocial intervention interaction. There was a relatively low level of medication adherence (50% adhered) across conditions, and this was associated with poor outcome.

Conclusions: Results from this 24-week treatment study demonstrate the importance of the psychosocial component in the treatment of alcohol dependence. Moreover, results demonstrate a substantial association between medication adherence and treatment outcomes. The findings suggest that further research is needed to determine the appropriate use of pharmacotherapy in maximizing treatment response.

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Figures

Fig. 1
Fig. 1
The number of days of any drinking (log transformed) during each 4-week time block by group. The CBT group demonstrated significantly lower drinking than the other therapy groups (p < 0.01).
Fig. 2
Fig. 2
The number of days of any heavy drinking (log transformed) during each 4-week time block by group. The CBT group demonstrated significantly fewer periods of heavy drinking than the other therapy groups (p < 0.001).
See this image and copyright information in PMC

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