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

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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:
Collaborator:
University of Wisconsin, Milwaukee
Information provided by (Responsible Party):
James Garbutt, MD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcohol Dependence
Intervention Drug: Acamprosate (Campral)
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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. 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.
Period Title: Overall Study
Started 51 49
Completed 39 41
Not Completed 12 8
Reason Not Completed
Lost to Follow-up             8             6
Withdrawal by Subject             3             1
wanted more care             0             1
incarcerated             1             0
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo Total
Hide Arm/Group 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 51 49 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 49 participants 100 participants
46.6  (7.7) 47.7  (8.5) 47.1  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 100 participants
Female
21
  41.2%
17
  34.7%
38
  38.0%
Male
30
  58.8%
32
  65.3%
62
  62.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 49 participants 100 participants
51 49 100
1.Primary Outcome
Title % Dropout
Hide Description Percentage of participants who dropped out of study by drug condition
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: percentage of participants
21.5 16.3
2.Primary Outcome
Title Percent Days Abstinent
Hide Description %Days without any alcohol consumption over the treatment period
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 51 49
Mean (Standard Deviation)
Unit of Measure: percentage of days
40.7  (30.6) 41.6  (33.0)
3.Secondary Outcome
Title Retention
Hide Description Number of individuals retained in the trial by acamprosate vs placebo group
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
39 41
4.Secondary Outcome
Title Percent With Complete Abstinence
Hide Description % of subjects with no drinking during the 12 week treatment trial
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: percentage of participants
5.9 19.1
5.Secondary Outcome
Title % Heavy Drinking Days During Trial
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 51 49
Mean (Standard Deviation)
Unit of Measure: percentage of heavy drinking days
15.8  (21.3) 18.4  (23.4)
6.Secondary Outcome
Title Clinical Global Impression Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 51 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (0.9) 2.4  (1.2)
7.Secondary Outcome
Title % Compliant With Medication
Hide Description % of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: percentage of participants
93.3 91.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1- Acamprosate 2 - Sugar Pill - Placebo
Hide Arm/Group 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. 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.
All-Cause Mortality
1- Acamprosate 2 - Sugar Pill - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1- Acamprosate 2 - Sugar Pill - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/49 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1- Acamprosate 2 - Sugar Pill - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   17/51 (33.33%)   12/49 (24.49%) 
Gastrointestinal disorders     
Diarrhea   17/51 (33.33%)  12/49 (24.49%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. J.C. Garbutt
Organization: University of North Carolina at Chapel Hill
Phone: 919-966-4652
Responsible Party: James Garbutt, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00381043     History of Changes
Other Study ID Numbers: CMP-MD-06
First Submitted: September 26, 2006
First Posted: September 27, 2006
Results First Submitted: September 13, 2012
Results First Posted: March 22, 2013
Last Update Posted: May 17, 2017