Completed
Etiology and Treatment of Alcohol Dependence
What is being tested
acamprosate (Campral)
Drug
Who is being recruted
Mental Disorders+2
+ Substance-Related Disorders
+ Alcohol-Related Disorders
From 21 to 55 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorYale University
Last updated: July 2, 2015
Sourced from a government-validated database.Claim as a partner
This study will examine whether pretreatment with two doses of acamprosate for seven days prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate or placebo for seven days. This will be followed by a four- day inpatient period when withdrawal will be monitored. Additional drinking information will be obtained at a three month followup interview.
Principal SponsorYale University
Last updated: July 2, 2015
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
120 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 21 to 55 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 at 6th grade level or higher and to complete study evaluations
Average weekly alcohol consumption of standard drinks of at least 25 drinks for men and 20 drinks for women
Meets criteria for alcohol abuse or dependence
No more than 3 days abstinence/week
14 exclusion criteria prevent from participating
Alcohol withdrawal symptoms requiring management with benzodiazepines
Current abuse or dependence on other substances, other than nicotine and marijuana
Females who are pregnant, nursing or not using a reliable method of birth control
Hepatocellular disease or a history of cirrhosis
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
Substance Abuse Treatment Unit, University of Connecticut
New Haven, United StatesOpen Substance Abuse Treatment Unit, University of Connecticut in Google MapsCompletedOne Study Center