Naltrexone for Early Problem Drinkers

Alcoholism Clinical Trial

Official title:

Targeted Naltrexone for Early Problem Drinkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000455
• Other study ID #: NIAAAKRA11062
• Secondary ID: R01AA011062
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 17, 2011
• Est. completion date: September 2002

Study information

• Verified date: June 2011
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence).

• Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women.

• Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.

• Willing to provide a collateral informant for interviews regarding the patient's drinking during the study.

• A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment.

• Willing to provide a signed informed consent to participate in the study.

Exclusion Criteria:

• Have a current clinically significant physical disease or abnormality.

• Have a serious psychiatric illness.

• Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence.

• A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms.

• Used opioids or other psychoactive medications regularly in the month prior to study enrollment.

• History of hypersensitivity to naltrexone (Revia).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone

Locations

Country	Name	City	State
United States	Department of Psychiatry, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut Health Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,