Trials
Search / Trial NCT00000448

Naltrexone Treatment for Alcoholic Women

Launched by YALE UNIVERSITY · Nov 2, 1999

Trial Information

Current as of January 15, 2025

Completed

Keywords

ClinConnect Summary

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 random...

Gender

FEMALE

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.

Trial Officials

Stephanie S O'Malley, PhD

Principal Investigator

Yale School of Medicine

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

New Haven, Connecticut, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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