Completed

Phase 4
Age: 18Years - 50Years
FEMALE
ID00000448

Naltrexone: Consummatory Behaviors in Alcoholic Women

Led by Yale University · Updated on 2014-05-07

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Naltrexone Treatment for Alcoholic Women

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

Trial Site Locations

Total: 1 location

1

Substance Abuse Treatment Unit, Yale University

New Haven, Connecticut, United States, 06511

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Stephanie S O'Malley, Rajita Sinha, Carlos M Grilo...

https://pubmed.ncbi.nlm.nih.gov/17374042