- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381043
Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Family Medicine Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% Dropout
Time Frame: 12 weeks
|
Percentage of participants who dropped out of study by drug condition
|
12 weeks
|
Percent Days Abstinent
Time Frame: 12 weeks
|
%Days without any alcohol consumption over the treatment period
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention
Time Frame: 12 weeks
|
Number of individuals retained in the trial by acamprosate vs placebo group
|
12 weeks
|
Percent With Complete Abstinence
Time Frame: 12 weeks
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% of subjects with no drinking during the 12 week treatment trial
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12 weeks
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% Heavy Drinking Days During Trial
Time Frame: 12 weeks
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% 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.
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12 weeks
|
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
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12 weeks
|
% 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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12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: JC Garbutt, MD, University of North Carolina, Chapel Hill
Publications and helpful links
General Publications
- Paille FM, Guelfi JD, Perkins AC, Royer RJ, Steru L, Parot P. Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol. Alcohol Alcohol. 1995 Mar;30(2):239-47.
- Pelc I, Verbanck P, Le Bon O, Gavrilovic M, Lion K, Lehert P. Efficacy and safety of acamprosate in the treatment of detoxified alcohol-dependent patients. A 90-day placebo-controlled dose-finding study. Br J Psychiatry. 1997 Jul;171:73-7. doi: 10.1192/bjp.171.1.73.
- Sass H, Soyka M, Mann K, Zieglgansberger W. Relapse prevention by acamprosate. Results from a placebo-controlled study on alcohol dependence. Arch Gen Psychiatry. 1996 Aug;53(8):673-80. doi: 10.1001/archpsyc.1996.01830080023006. Erratum In: Arch Gen Psychiatry 1996 Dec;53(12):1097.
- Berger L, Fisher M, Brondino M, Bohn M, Gwyther R, Longo L, Beier N, Ford A, Greco J, Garbutt JC. Efficacy of acamprosate for alcohol dependence in a family medicine setting in the United States: a randomized, double-blind, placebo-controlled study. Alcohol Clin Exp Res. 2013 Apr;37(4):668-74. doi: 10.1111/acer.12010. Epub 2012 Nov 7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMP-MD-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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