Completed

Naltrexone: Consummatory Behaviors in Alcoholic Women

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What is being tested

Placebo

+ naltrexone

Drug
Who is being recruted

Mental Disorders+6

+ Signs and Symptoms

+ Signs and Symptoms, Digestive

From 18 to 50 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: October 1995
See protocol details

Summary

Principal SponsorYale University
Last updated: May 7, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00000448
Principal SponsorYale University
Last updated: May 7, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholismFeeding and Eating Disorders

Criteria

3 inclusion criteria required to participate
A stable residence and a telephone to ensure that subjects can be located during the study
Able to read English and complete study evaluations
Meets criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days
10 exclusion criteria prevent from participating
Abstinent longer than 30 days prior to admission to program
Current use of disulfiram (Antabuse)
Hepatocellular disease or elevated bilirubin levels
Individuals with present history of opiate abuse or who require the use of opioid analgesics
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Subjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks.

Group II

Experimental
Subjects were prescribed 25 mg naltrexone for 2 days, followed by daily doses of 50 mg of naltrexone for a total of 12 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Substance Abuse Treatment Unit, Yale University

New Haven, United StatesOpen Substance Abuse Treatment Unit, Yale University in Google Maps
CompletedOne Study Center