Clinical trial NCT00000448: Naltrexone Treatment for Alcoholic Women
Official title: Naltrexone: Consummatory Behaviors in Alcoholic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Eating Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess naltrexone's effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women. Alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for 12 weeks, with followup 6 months after treatment.

Detailed description: 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 or placebo for 12 weeks in addition to weekly group CBCST.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days.
* Able to read English and complete study evaluations.
* A stable residence and a telephone to ensure that subjects can be located during the study.

Exclusion Criteria:

* Meets criteria for dependence on another psychoactive substance besides alcohol or nicotine.
* Regular use of psychoactive drugs except antidepressants.
* Current use of disulfiram (Antabuse).
* Psychotic or otherwise severely psychiatrically disabled.
* Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac pathology.
* Abstinent longer than 30 days prior to admission to program.
* Hepatocellular disease or elevated bilirubin levels.
* Individuals with present history of opiate abuse or who require the use of opioid analgesics.
* Women who are pregnant, nursing, or not using a reliable method of birth control.
* Women who are significantly overweight or significantly underweight.

Primary outcomes:
measure: Time to first day of drinking
timeFrame: 12 week treatment period
measure: Time to first day of heavy drinking
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of days abstinent
timeFrame: 12 weeks of treatment
measure: Percentage of heavy drinking days
timeFrame: 12 weeks of treatment
measure: Beck Depression Index
timeFrame: 12 weeks of treatment
measure: Obsessive Compulsive Drinking Scale (OCDS)
timeFrame: Baseline, Month 1, 2, 3
measure: Eating Disorder Examination (EDE)
timeFrame: baseline, month 1, 2, 3
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit, Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Stephanie S O'Malley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Malley SS, Sinha R, Grilo CM, Capone C, Farren CK, McKee SA, Rounsaville BJ, Wu R. 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. Alcohol Clin Exp Res. 2007 Apr;31(4):625-34. doi: 10.1111/j.1530-0277.2007.00347.x.