Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Alcohol Dependence
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Dependence, Family Medicine Setting, University of North Carolina at Chapel Hill
Eligibility 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.
Sites / Locations
- UNC Family Medicine Center
- Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
1- Acamprosate
2 - Sugar Pill - Placebo
The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.