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.
Center for the Study of Addictions, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA. oslin@mail.med.upenn.edu
David W
DW
Oslin
Kevin G
KG
Lynch
Helen M
HM
Pettinati
Kyle M
KM
Kampman
Peter
P
Gariti
Lois
L
Gelfand
Thomas
T
Ten Have
Shoshana
S
Wortman
William
W
Dundon
Charles
C
Dackis
Joseph R
JR
Volpicelli
Charles P
CP
O'Brien
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