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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381043
• Other study ID #: CMP-MD-06
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2006
• Last updated: February 18, 2013
• Start date: August 2006
• Est. completion date: July 2008

Study information

• Verified date: February 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
United States	UNC Family Medicine Center	Chapel Hill	North Carolina
United States	Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Sass H, Soyka M, Mann K, Zieglgänsberger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Dropout	Percentage of participants who dropped out of study by drug condition	12 weeks	Yes
Primary	Percent Days Abstinent	%Days without any alcohol consumption over the treatment period	12 weeks	No
Secondary	Retention	Number of individuals retained in the trial by acamprosate vs placebo group	12 weeks	Yes
Secondary	Percent With Complete Abstinence	% of subjects with no drinking during the 12 week treatment trial	12 weeks	No
Secondary	% 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	No
Secondary	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	No
Secondary	% Compliant With Medication	% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.	12 weeks	Yes