Status:
COMPLETED
Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
University of Wisconsin, Milwaukee
Conditions:
Alcohol Dependence
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief Summary
This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more effective fo...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00381043
Start Date
August 1 2006
End Date
July 1 2008
Last Update
May 17 2017
Active Locations (2)
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1
UNC Family Medicine Center
Chapel Hill, North Carolina, United States, 27599
2
Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53211