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

Completed · Phase 4 · Has a placebo group

Conditions studied: Alcohol Dependence

In brief

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 for helping with drinking in a Family Medicine clinic.

Key facts

Study ID

NCT00381043

Run by

University of North Carolina, Chapel Hill

People needed

100

Starts

2006-08-01

Expected to finish

2008-07-01

Last updated by the study team

2017-05-17

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UNC Family Medicine Center — Chapel Hill, North Carolina, United States
• Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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