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A Placebo‐Controlled Randomized Clinical Trial of Naltrexone in the Context of Different Levels of Psychosocial Intervention
Author(s) -
Oslin David W.,
Lynch Kevin G.,
Pettinati Helen M.,
Kampman Kyle M.,
Gariti Peter,
Gelfand Lois,
Ten Have Thomas,
Wortman Shoshana,
Dundon William,
Dackis Charles,
Volpicelli Joseph R.,
O’Brien Charles P.
Publication year - 2008
Publication title -
alcoholism: clinical and experimental research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.267
H-Index - 153
eISSN - 1530-0277
pISSN - 0145-6008
DOI - 10.1111/j.1530-0277.2008.00698.x
Subject(s) - psychosocial , naltrexone , medicine , placebo , randomized controlled trial , context (archaeology) , psychological intervention , alcohol dependence , adverse effect , psychiatry , pharmacotherapy , cognitive behavioral therapy , intervention (counseling) , alcohol use disorder , clinical trial , physical therapy , alcohol , alternative medicine , paleontology , biochemistry , chemistry , receptor , pathology , opioid , biology
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.