A placebo-controlled randomized clinical trial of naltrexone in the context of different levels of psychosocial intervention.
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.
Oslin
David W
DW
Center for the Study of Addictions, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA. oslin@mail.med.upenn.edu
Lynch
Kevin G
KG
Pettinati
Helen M
HM
Kampman
Kyle M
KM
Gariti
Peter
P
Gelfand
Lois
L
Ten Have
Thomas
T
Wortman
Shoshana
S
Dundon
William
W
Dackis
Charles
C
Volpicelli
Joseph R
JR
O'Brien
Charles P
CP
D000328:Adult; D000428:Alcohol Drinking; D000437:Alcoholism / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D015928:Cognitive Behavioral Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D010358:Patient Participation; D011320:Primary Health Care; D016896:Treatment Outcome
D009292:Narcotic Antagonists; D009271:Naltrexone