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Naltrexone for Early Problem Drinkers

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naltrexone
Sponsored by
UConn Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Psychiatry, University of Pennsylvania

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 17, 2011
Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000455
Brief Title
Naltrexone for Early Problem Drinkers
Official Title
Targeted Naltrexone for Early Problem Drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naltrexone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Department of Psychiatry, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

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Naltrexone for Early Problem Drinkers

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