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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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 for helping with drinking in a Family Medicine clinic.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: University of Wisconsin, Milwaukee
• Treatments: Acamprosate; Ethanol

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.