NCT00381043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

March 22, 2013

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

September 26, 2006

Results QC Date

September 13, 2012

Last Update Submit

April 11, 2017

Conditions

Alcohol Dependence

Keywords

Alcohol DependenceFamily Medicine SettingUniversity of North Carolina at Chapel Hill

Outcome Measures

Primary Outcomes (2)

  • % Dropout

    Percentage of participants who dropped out of study by drug condition

    12 weeks

  • Percent Days Abstinent

    %Days without any alcohol consumption over the treatment period

    12 weeks

Secondary Outcomes (5)

  • Retention

    12 weeks

  • Percent With Complete Abstinence

    12 weeks

  • % Heavy Drinking Days During Trial

    12 weeks

  • Clinical Global Impression Scale

    12 weeks

  • % Compliant With Medication

    12 weeks

Study Arms (2)

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)

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)

Interventions

Acamprosate (Campral)DRUG

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.

Also known as: Acamprosate, campral, alcohol dependence medication
1- Acamprosate2 - Sugar Pill - Placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Men and women ages 21 to 65 years with a diagnosis of alcohol dependence.
  • \. 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.
  • \. Ability to understand and sign written informed consent.
  • \. Willingness to refrain from drinking for at least three days prior to randomization.
  • \. Willingness to consider a goal of abstinence or a significant reduction in drinking as an objective.

You may not qualify if:

  • \. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern.
  • \. Clinically significant psychiatric disease, e.g. bipolar disorder, psychosis, that might interfere with study participation or present a safety concern. \[Subjects with depression or an anxiety disorder who are receiving medication and are clinically stable for at least one month will not be excluded.\]
  • \. Suicidal ideation or behavior, history of suicide attempt.
  • \. Renal Impairment; estimated creatinine clearance \<50 ml/min.
  • \. Substance use disorder other than alcohol or nicotine dependence or cannabis abuse.
  • \. 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).
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UNC Family Medicine Center

Chapel Hill, North Carolina, 27599, United States

Location

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

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (4)

  • 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.

    PMID: 7662044BACKGROUND

  • 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.

    PMID: 9328500BACKGROUND

  • 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.

    PMID: 8694680BACKGROUND

  • 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.

    PMID: 23134193DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

AcamprosateEthanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur CompoundsAlcohols

Results Point of Contact

Title
Dr. J.C. Garbutt
Organization
University of North Carolina at Chapel Hill
jc_garbutt@med.unc.edu
919-966-4652

Study Officials

  • JC Garbutt, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 27, 2006

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 17, 2017

Results First Posted

March 22, 2013

Record last verified: 2017-04

Locations

US(2)