Completed

Targeted Naltrexone for Early Problem Drinkers

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What is being tested

naltrexone

Drug
Who is being recruted

Mental Disorders+2

+ Substance-Related Disorders

+ Alcohol-Related Disorders

From 18 to 60 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
See protocol details

Summary

Principal SponsorUConn Health
Last updated: June 20, 2011
Sourced from a government-validated database.Claim as a partner

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.

NCT00000455
Principal SponsorUConn Health
Last updated: June 20, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholism

Criteria

6 inclusion criteria required to participate
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
Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment
Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women
Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence)
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6 exclusion criteria prevent from participating
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
Have a current clinically significant physical disease or abnormality
Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence
Have a serious psychiatric illness
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Psychiatry, University of Pennsylvania

Philadelphia, United StatesOpen Department of Psychiatry, University of Pennsylvania in Google Maps
CompletedOne Study Center