Naltrexone for Early Problem Drinkers

NCT00000455 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2011-06-20

No results posted yet for this study

Summary

Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence.

Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.

Conditions

  • Alcoholism

Interventions

DRUG

naltrexone

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • UConn Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2002-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000455 on ClinicalTrials.gov