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

Condition(s) targeted: Alcohol Dependence

Intervention: Acamprosate (Campral) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of North Carolina

Official(s) and/or principal investigator(s):
JC Garbutt, MD, Principal Investigator, Affiliation: The University of North Carolina, Chapel Hill

Overall contact:
Amy Ford, MA, Phone: 919-966-5239, Email: aford@med.unc.edu

This is a study of a medication, Campral (acamprosate), which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate (Campral) compared to a sugar pill (placebo) is more effective for helping with drinking 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 design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome:

Percent days abstinent from pre-treatment to in or post treatment

Adherence to medicine

Drop-out/loss to follow-up rate

Secondary outcome:

Percent days complete abstinent

Percent heavy drinking days

Clinical Global Impression

Detailed description: Campral (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 Campral (acamprosate)for 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 Campral (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 Campral (acamprosate) group compared to the placebo group.

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Amy Ford, MA, Phone: 919-966-5239, Email: aford@med.unc.edu

UNC Family Medicine Center, Chapel Hill, North Carolina 27599, United States; Recruiting
Amy Ford, MA, Phone: 919-966-5239, Email: aford@med.unc.edu
Linda Kalka-Juhl, CMA, Phone: 919-966-5770, Email: lkjuhl@med.unc.edu
JC Garbutt, MD, Principal Investigator
Mike Fisher, MD, Sub-Investigator
Remy Coeytaux, MD, Sub-Investigator
Bob Gwyther, MD, Sub-Investigator

Related 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.

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. Erratum in: Arch Gen Psychiatry 1996 Dec;53(12):1097.

Starting date: August 2006
Ending date: August 2007
Last updated: March 15, 2007