Completed

Naltrexone for Early Problem Drinkers

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What is being tested

naltrexone

Drug
Who is being recruted

Alcoholism

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.

Official TitleTargeted Naltrexone for Early Problem Drinkers 
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alcoholism
Criteria
6 inclusion criteria required to participate
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

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6 exclusion criteria prevent from participating
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

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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
Suspended
Department of Psychiatry, University of PennsylvaniaPhiladelphia, United StatesSee the location
CompletedOne Study Center
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