Naltrexone and cognitive behavioral coping skills therapy for the treatment of alcohol drinking and eating disorder features in alcohol-dependent women: a randomized controlled trial.
BACKGROUND
Despite important gender differences in drinking patterns, physiological effects of alcohol, and co-occurring psychiatric conditions, relatively little is known about the efficacy of naltrexone for the treatment of alcohol dependence in women. This study investigated the safety and efficacy of naltrexone in combination with Cognitive Behavioral Coping Skills Therapy (CBCST) in a sample of alcohol-dependent women, some with comorbid eating pathology.


METHODS
One hundred three women meeting DSM-IV criteria for alcohol dependence (29 with comorbid eating disturbances) were randomized to receive either naltrexone 50 mg or placebo for 12 weeks in addition to weekly group CBCST. Subjects were enrolled between October 1995 and December 2000 at an outpatient research clinic.


RESULTS
No significant differences were observed on the primary outcomes of time to first drinking day, time to first day of heavy drinking, or the percentage of participants who continued to meet the criteria for alcohol dependence. Secondary analyses revealed that naltrexone significantly delayed the time to the second (chi2=5.37, p=0.02) and third (chi2=4.35, p=0.04) drinking days among subjects who did not maintain abstinence from alcohol. Among those with eating disturbances, symptoms of eating pathology improved during treatment, but the effects did not differ according to medication condition.


CONCLUSIONS
When used in conjunction with CBCST, naltrexone did not significantly improve drinking outcomes in the overall sample of alcohol-dependent women. However, naltrexone may be of benefit to women who are unable to maintain total abstinence from alcohol. For women with concurrent eating pathology, participation in treatment for alcoholism may be associated with improvements in eating pathology.
O'Malley
Stephanie S
SS
Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA. Stephanie.omalley@yale.edu
Sinha
Rajita
R
Grilo
Carlos M
CM
Capone
Christy
C
Farren
Conor K
CK
McKee
Sherry A
SA
Rounsaville
Bruce J
BJ
Wu
Ran
R
D000223:Adaptation, Psychological; D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D000437:Alcoholism / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D001290:Attitude; D015992:Body Mass Index; D002032:Bulimia / Q000523:psychology; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003863:Depression / Q000523:psychology; D001068:Feeding and Eating Disorders / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D005723:gamma-Glutamyltransferase / Q000097:blood
D009292:Narcotic Antagonists; D009271:Naltrexone; D005723:gamma-Glutamyltransferase