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

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.


Condition Intervention Phase
Alcohol Dependence
Drug: Acamprosate (Campral)
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Percent days abstinent from pre-treatment to in or post treatment
  • Adherence to medicine
  • Drop-out/loss to follow-up rate

Secondary Outcome Measures:
  • Percent days complete abstinent
  • Percent heavy drinking days
  • Clinical Global Impression

Estimated Enrollment: 50
Study Start Date: August 2006
Estimated Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381043

Contacts
Contact: Amy Ford, MA 919-966-5239 aford@med.unc.edu
Contact: Linda Kalka-Juhl, CMA 919-966-5770 lkjuhl@med.unc.edu

Locations
United States, North Carolina
UNC Family Medicine Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Amy Ford, MA     919-966-5239     aford@med.unc.edu    
Contact: Linda Kalka-Juhl, CMA     919-966-5770     lkjuhl@med.unc.edu    
Principal Investigator: JC Garbutt, MD            
Sub-Investigator: Mike Fisher, MD            
Sub-Investigator: Remy Coeytaux, MD            
Sub-Investigator: Bob Gwyther, MD            
Sponsors and Collaborators
University of North Carolina
Investigators
Principal Investigator: JC Garbutt, MD The University of North Carolina, Chapel Hill
  More Information

Publications:
Study ID Numbers: CMP-MD-06
Study First Received: September 26, 2006
Last Updated: March 15, 2007
ClinicalTrials.gov Identifier: NCT00381043     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:
Alcohol Dependence
Family Medicine Setting
University of North Carolina at Chapel Hill

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Acamprosate
Ethanol

Additional relevant MeSH terms:
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents
Acamprosate

ClinicalTrials.gov processed this record on July 02, 2009