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Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic

This study is currently recruiting participants.
Information provided by University of North Carolina

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Descriptive Information Fields
Brief Title  Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Official Title  Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study
Brief Summary

This is a study of a medication, Campral (acamprosate), which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate (Campral) compared to a sugar pill (placebo) is more effective for helping with drinking in a Family Medicine clinic.

Detailed Description

Campral (acamprosate) has been shown to reduce drinking days in alcohol dependent patients and promote abstinence, with few reported side effects. A limitation of these studies, however, has been their lack of generalizability due to restrictive inclusion and exclusion criteria. Furthermore, most of the previous studies of acamprosate have been conducted in Europe, in a different treatment setting from the typical American Family Medicine center, where alcohol dependent patients are most likely to be first identified in the U.S.

The present study is designed to determine the efficacy of Campral (acamprosate)for alcohol dependence in a Family Medicine setting using minimal psychotherapeutic interventions—as would also likely occur in a primary care setting. The study will be a 12-week, double-blind, placebo-controlled, randomized trial comparing 666 mg Campral (acamprosate) t.i.d. to placebo in patients at the UNC Family Medicine Center with alcohol dependence. Subjects will be seen by Family Medicine physicians and receive brief motivational interventions. Primary efficacy will be determined by measuring % days abstinent and secondary outcomes include rates of complete abstinence, % heavy drinking days, CGI and GGT in the Campral (acamprosate) group compared to the placebo group.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Percent days abstinent from pre-treatment to in or post treatment
Adherence to medicine
Drop-out/loss to follow-up rate
Secondary Outcome Measure  Percent days complete abstinent
Percent heavy drinking days
Clinical Global Impression
Condition  Alcohol Dependence
Intervention  Drug: Acamprosate (Campral)
MEDLINE PMIDs 7662044,   9328500,   8694680
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  50
Start Date  August 2006
Completion Date August 2007
Eligibility Criteria 

Inclusion Criteria:

  1. Men and women ages 21 to 65 years with a diagnosis of alcohol dependence.
  2. History of at least 2 heavy drinking days (men > 5 drinks/day; women > 4 drinks/day) per week, on average, during the month prior to screening.
  3. Ability to understand and sign written informed consent.
  4. Willingness to refrain from drinking for at least three days prior to randomization.
  5. Willingness to consider a goal of abstinence or a significant reduction in drinking as an objective.

Exclusion Criteria

  1. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern.
  2. Clinically significant psychiatric disease, e.g. bipolar disorder, psychosis, that might interfere with study participation or present a safety concern. [Subjects with depression or an anxiety disorder who are receiving medication and are clinically stable for at least one month will not be excluded.]
  3. Suicidal ideation or behavior, history of suicide attempt.
  4. Renal Impairment; estimated creatinine clearance <50 ml/min.
  5. Substance use disorder other than alcohol or nicotine dependence or cannabis abuse.
  6. Pregnant or breastfeeding women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).
  7. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence. Individuals may be considered for the trial upon completion of medical detoxification.
Gender Both
Ages 21 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Amy Ford, MA     919-966-5239     aford@med.unc.edu    
Contact: Linda Kalka-Juhl, CMA     919-966-5770     lkjuhl@med.unc.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00381043
Organization ID CMP-MD-06
Secondary IDs ††
Study Sponsor  University of North Carolina
Collaborators ††
Investigators 
Principal Investigator:     JC Garbutt, MD     University of North Carolina    
Information Provided By University of North Carolina
Verification Date March 2007
First Received Date  September 26, 2006
Last Updated Date March 15, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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