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

• ClinicalTrials.gov Identifier: NCT00381043
• Recruitment Status: Completed
• First Posted: September 27, 2006
• Results First Posted: March 22, 2013
• Last Update Posted: May 17, 2017
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: University of Wisconsin, Milwaukee
• Information provided by (Responsible Party): James Garbutt, MD, University of North Carolina, Chapel Hill

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.

Condition or disease	Intervention/treatment	Phase
Alcohol Dependence	Drug: Acamprosate (Campral)	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Campral (Acamprosate) Treatment of Alcohol Dependence in a Family Medicine Setting: A Randomized, Double-Blind Placebo-Controlled Study
• Study Start Date: August 2006
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1- Acamprosate; 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.; Other Name: Acamprosate, campral, alcohol dependence medication
Placebo Comparator: 2 - Sugar Pill - Placebo; 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.; Other Name: Acamprosate, campral, alcohol dependence medication

Outcome Measures

Primary Outcome Measures :

1. % Dropout [ Time Frame: 12 weeks ]
   Percentage of participants who dropped out of study by drug condition
2. Percent Days Abstinent [ Time Frame: 12 weeks ]
   %Days without any alcohol consumption over the treatment period

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

University of North Carolina, Chapel Hill

University of Wisconsin, Milwaukee

Investigators

• Principal Investigator: JC Garbutt, MD; 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, 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: James Garbutt, MD, Professor of Psychiatry, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT00381043
• Other Study ID Numbers: CMP-MD-06
• First Posted: September 27, 2006
• Results First Posted: March 22, 2013
• Last Update Posted: May 17, 2017
• Last Verified: April 2017

Keywords provided by James Garbutt, MD, University of North Carolina, Chapel Hill:

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

Additional relevant MeSH terms:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Ethanol; Acamprosate; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Alcohol Deterrents