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

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
1- Acamprosate	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.
2 - Sugar Pill - Placebo	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.

Primary Outcome Measures

Name	Time	Method
% Dropout	12 weeks	Percentage of participants who dropped out of study by drug condition
Percent Days Abstinent	12 weeks	%Days without any alcohol consumption over the treatment period

Secondary Outcome Measures

Name	Time	Method
Retention	12 weeks	Number of individuals retained in the trial by acamprosate vs placebo group
% Heavy Drinking Days During Trial	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.
% Compliant With Medication	12 weeks	% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.
Percent With Complete Abstinence	12 weeks	% of subjects with no drinking during the 12 week treatment trial
Clinical Global Impression Scale	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

Locations (2): Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee
🇺🇸
Milwaukee, Wisconsin, United States
UNC Family Medicine Center
🇺🇸
Chapel Hill, North Carolina, United States