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Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
This study is currently recruiting participants.
Study NCT00381043   Information provided by The University of North Carolina, Chapel Hill
First Received: September 26, 2006   Last Updated: March 15, 2007   History of Changes

September 26, 2006
March 15, 2007
August 2006
 
  • Percent days abstinent from pre-treatment to in or post treatment
  • Adherence to medicine
  • Drop-out/loss to follow-up rate
Same as current
Complete list of historical versions of study NCT00381043 on ClinicalTrials.gov Archive Site
  • Percent days complete abstinent
  • Percent heavy drinking days
  • Clinical Global Impression
Same as current
 
Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Alcohol Dependence
Drug: Acamprosate (Campral)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
August 2007
 

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.
Both
21 Years to 65 Years
No
Contact: Amy Ford, MA 919-966-5239 aford@med.unc.edu
Contact: Linda Kalka-Juhl, CMA 919-966-5770 lkjuhl@med.unc.edu
United States
 
NCT00381043
 
CMP-MD-06
University of North Carolina
 
Principal Investigator: JC Garbutt, MD The University of North Carolina, Chapel Hill
The University of North Carolina, Chapel Hill
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP