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 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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

Baseline Characteristics

Arm/Group Title		1- Acamprosate	2 - Sugar Pill - Placebo	Total
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
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

Outcome Measures

1. Primary Outcome

Title	% Dropout
Description	Percentage of participants who dropped out of study by drug condition
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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
Description	%Days without any alcohol consumption over the treatment period
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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
Description	Number of individuals retained in the trial by acamprosate vs placebo group
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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
Description	% of subjects with no drinking during the 12 week treatment trial
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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
Description	% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	1- Acamprosate	2 - Sugar Pill - Placebo
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	--/--	--/--
Serious Adverse Events
	1- Acamprosate	2 - Sugar Pill - Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/51 (0.00%)	0/49 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: jc_garbutt@med.unc.edu

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. doi: 10.1192/bjp.171.1.73.

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.

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, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT00381043
• 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