Completed

Naltrexone for Relapse Prevention

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What is being tested

naltrexone (Revia)

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

This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.

Official TitleEtiology and Treatment of Alcohol Dependence 
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
57 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 treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

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
4 inclusion criteria required to participate
Meets criteria for alcohol dependence
Abstinent from alcohol for a period of at least 3 days prior to beginning of study
Able to read English and complete study evaluations
Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control
8 exclusion criteria prevent from participating
Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis
Prior history of opioid dependence
Regular use of psychoactive drugs including anxiolytics and antidepressants
Prior treatment with naltrexone

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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