Completed
Etiology and Treatment of Alcohol Dependence
What is being tested
naltrexone (Revia)
Drug
Who is being recruted
Mental Disorders+2
+ Substance-Related Disorders
+ Alcohol-Related Disorders
From 18 to 60 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
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.
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 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
4 inclusion criteria required to participate
Able to read English and complete study evaluations
Abstinent from alcohol for a period of at least 3 days prior to beginning of study
Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control
Meets criteria for alcohol dependence
8 exclusion criteria prevent from participating
Abstinent longer than 28 days prior to randomization
Current use of disulfiram
Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis
Prior history of opioid dependence
Show More Criteria
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 MapsCompletedOne Study Center