Clinical trial NCT00381043: Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Official title: Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence
Family Medicine Setting
University of North Carolina at Chapel Hill
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Milwaukee
First posted: 2006-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: % Dropout
timeFrame: 12 weeks
measure: Percent Days Abstinent
timeFrame: 12 weeks
Secondary outcomes:
measure: Retention
timeFrame: 12 weeks
measure: Percent With Complete Abstinence
timeFrame: 12 weeks
measure: % Heavy Drinking Days During Trial
timeFrame: 12 weeks
measure: Clinical Global Impression Scale
timeFrame: 12 weeks
measure: % Compliant With Medication
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Family Medicine Center
state: North Carolina
city: Milwaukee
country: United States
facility: Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee
state: Wisconsin
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: JC Garbutt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.