Status:
COMPLETED
Naltrexone for Early Problem Drinkers
Lead Sponsor:
UConn Health
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 ...
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).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 2002
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00000455
End Date
September 1 2002
Last Update
June 20 2011
Active Locations (1)
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1
Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103