Gender differences with high-dose naltrexone in patients with co-occurring cocaine and alcohol dependence.
This is a randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy of a higher-than-typical daily dose of naltrexone (150 mg/day), taken for 12 weeks, in 164 patients (n = 116 men and n = 48 women) with co-occurring cocaine and alcohol dependence. Patients were stratified by gender and then randomly assigned to either naltrexone or placebo, and to either cognitive-behavioral therapy or a type of medical management. The two primary outcomes were cocaine use and alcohol use. Significant Gender x Medication interactions were found for cocaine use via urine drug screens (three way, with time) and self-reports (two way) for drug severity (two way) and alcohol use (two way). The type of psychosocial treatment did not affect outcomes. Thus, 150 mg/day naltrexone added to a psychosocial treatment resulted in reductions in cocaine and alcohol use and drug severity in men, compared to higher rates of cocaine and alcohol use and drug severity in women.
Department of Psychiatry, Center for the Study of Addictions, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. pettinati_h@mail.trc.upenn.edu
Helen M
HM
Pettinati
Kyle M
KM
Kampman
Kevin G
KG
Lynch
Jesse J
JJ
Suh
Charles A
CA
Dackis
David W
DW
Oslin
Charles P
CP
O'Brien
D000293:Adolescent; D000328:Adult; D000368:Aged; D000437:Alcoholism / Q000453:epidemiology* / Q000534:rehabilitation*; D019970:Cocaine-Related Disorders / Q000453:epidemiology* / Q000534:rehabilitation*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D012737:Sex Factors
D009292:Narcotic Antagonists; D009271:Naltrexone