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

Primary Purpose

Alcohol Dependence

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acamprosate (Campral)

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Dependence, Family Medicine Setting, University of North Carolina at Chapel Hill

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UNC Family Medicine Center
Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1- Acamprosate

2 - Sugar Pill - Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

% Dropout

Percentage of participants who dropped out of study by drug condition

Percent Days Abstinent

%Days without any alcohol consumption over the treatment period

Secondary Outcome Measures

Retention

Number of individuals retained in the trial by acamprosate vs placebo group

Percent With Complete Abstinence

% of subjects with no drinking during the 12 week treatment trial

% 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.

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

% Compliant With Medication

% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.

Full Information

NCT ID

NCT00381043

First Posted

September 26, 2006

Last Updated

April 11, 2017

Sponsor

University of North Carolina, Chapel Hill

Collaborators

University of Wisconsin, Milwaukee

1. Study Identification

Unique Protocol Identification Number

NCT00381043

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

University of Wisconsin, Milwaukee

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence

Keywords

Alcohol Dependence, Family Medicine Setting, University of North Carolina at Chapel Hill

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1- Acamprosate

Arm Type

Active Comparator

Arm Description

Arm Title

2 - Sugar Pill - Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Acamprosate (Campral)

Other Intervention Name(s)

Acamprosate, campral, alcohol dependence medication

Intervention Description

Primary Outcome Measure Information:

Title

% Dropout

Description

Percentage of participants who dropped out of study by drug condition

Time Frame

12 weeks

Title

Percent Days Abstinent

Description

%Days without any alcohol consumption over the treatment period

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Retention

Description

Number of individuals retained in the trial by acamprosate vs placebo group

Time Frame

12 weeks

Title

Percent With Complete Abstinence

Description

% of subjects with no drinking during the 12 week treatment trial

Time Frame

12 weeks

Title

% Heavy Drinking Days During Trial

Description

% 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.

Time Frame

12 weeks

Title

Clinical Global Impression Scale

Description

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

Time Frame

12 weeks

Title

% Compliant With Medication

Description

% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JC Garbutt, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Family Medicine Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53211

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

7662044

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.

Results Reference

background

PubMed Identifier

9328500

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.

Results Reference

background

PubMed Identifier

8694680

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

Results Reference

background

PubMed Identifier

23134193

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.

Results Reference

derived

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

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