Naltrexone for Early Problem Drinkers

This study has been completed.

First Received on November 2, 1999. Last Updated on June 17, 2011 History of Changes

Sponsor:	University of Connecticut Health Center
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00000455

Purpose

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.

Condition	Intervention	Phase
Alcoholism	Drug: naltrexone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Primary Purpose: Treatment
Official Title:	Targeted Naltrexone for Early Problem Drinkers

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

Estimated Enrollment:	160
Estimated Study Completion Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000455

Locations

United States, Pennsylvania
Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103

Sponsors and Collaborators

University of Connecticut Health Center

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

Responsible Party:	Dr. Henry R. Kranzler, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00000455 History of Changes
Other Study ID Numbers:	NIAAAKRA11062, R01AA011062
Study First Received:	November 2, 1999
Last Updated:	June 17, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012