Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic - Full Text View

Sponsor:	The University of North Carolina, Chapel Hill
Collaborator:	University of Wisconsin, Milwaukee
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00381043

Purpose

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.

Condition	Intervention	Phase
Alcohol Dependence	Drug: Acamprosate (Campral)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Acamprosate calcium Acamprosate

U.S. FDA Resources

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Percent days abstinent from pre-treatment to in or post treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Adherence to medicine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Drop-out/loss to follow-up rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent days complete abstinent [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Percent heavy drinking days [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Clinical Global Impression [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	August 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1- Acamprosate: Active Comparator 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.	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.
2 - Sugar Pill - Placebo: Placebo Comparator 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.	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.

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.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381043

Locations

United States, North Carolina
UNC Family Medicine Center
Chapel Hill, North Carolina, United States, 27599
United States, Wisconsin
Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53211

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

University of Wisconsin, Milwaukee

Investigators

Principal Investigator:

JC Garbutt, MD

The University of North Carolina, Chapel Hill

More Information

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.

Responsible Party:	University of North Carolina-Chapel Hill ( James C. Garbutt, M.D., Principle Investigator )
Study ID Numbers:	CMP-MD-06
Study First Received:	September 26, 2006
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00381043 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

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

Additional relevant MeSH terms:

Anti-Infective Agents
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Depressants
Pharmacologic Actions
Acamprosate
Anti-Infective Agents, Local
Mental Disorders

Therapeutic Uses
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Central Nervous System Agents
Alcohol Deterrents
Ethanol

ClinicalTrials.gov processed this record on February 08, 2010