Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
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ClinicalTrials.gov Identifier: NCT00381043 |
Recruitment Status :
Completed
First Posted : September 27, 2006
Results First Posted : March 22, 2013
Last Update Posted : May 17, 2017
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Condition or disease | Intervention/treatment | Phase |
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Alcohol Dependence | Drug: Acamprosate (Campral) | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1- Acamprosate
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.
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Drug: Acamprosate (Campral)
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.
Other Name: Acamprosate, campral, alcohol dependence medication |
Placebo Comparator: 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.
|
Drug: Acamprosate (Campral)
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.
Other Name: Acamprosate, campral, alcohol dependence medication |
- % Dropout [ Time Frame: 12 weeks ]Percentage of participants who dropped out of study by drug condition
- Percent Days Abstinent [ Time Frame: 12 weeks ]%Days without any alcohol consumption over the treatment period
- Retention [ Time Frame: 12 weeks ]Number of individuals retained in the trial by acamprosate vs placebo group
- Percent With Complete Abstinence [ Time Frame: 12 weeks ]% of subjects with no drinking during the 12 week treatment trial
- % Heavy Drinking Days During Trial [ Time Frame: 12 weeks ]% 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.
- Clinical Global Impression Scale [ Time Frame: 12 weeks ]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
- % Compliant With Medication [ Time Frame: 12 weeks ]% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.

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Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381043
United States, North Carolina | |
UNC Family Medicine Center | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Wisconsin | |
Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee | |
Milwaukee, Wisconsin, United States, 53211 |
Principal Investigator: | JC Garbutt, MD | University of North Carolina, Chapel Hill |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | James Garbutt, MD, Professor of Psychiatry, University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00381043 |
Other Study ID Numbers: |
CMP-MD-06 |
First Posted: | September 27, 2006 Key Record Dates |
Results First Posted: | March 22, 2013 |
Last Update Posted: | May 17, 2017 |
Last Verified: | April 2017 |
Alcohol Dependence Family Medicine Setting University of North Carolina at Chapel Hill |
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |
Mental Disorders Acamprosate Alcohol Deterrents |