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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 acamprosatefor 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 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 acamprosate group compared to the placebo group.

Official Title
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Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Acamprosate (Campral)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1- Acamprosate<br>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. | Drug: Acamprosate (Campral)<br>* 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.<br>* Other names: Acamprosate, campral, alcohol dependence medication;|
| Placebo Comparator: 2 - Sugar Pill - Placebo<br>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. | Drug: Acamprosate (Campral)<br>* 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.<br>* Other names: Acamprosate, campral, alcohol dependence medication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Dropout | Percentage of participants who dropped out of study by drug condition | 12 weeks | 
| Percent Days Abstinent | %Days without any alcohol consumption over the treatment period | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | Number of individuals retained in the trial by acamprosate vs placebo group | 12 weeks | 
| Percent With Complete Abstinence | % of subjects with no drinking during the 12 week treatment trial | 12 weeks | 
| % Heavy Drinking Days During Trial | % of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial. | 12 weeks | 
| Clinical Global Impression Scale | Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill | 12 weeks | 
| % Compliant With Medication | % of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Family Medicine Setting, University of North Carolina at Chapel Hill