Trial Outcomes & Findings for Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic (NCT NCT00381043)
NCT ID: NCT00381043
Last Updated: 2017-05-17
Results Overview
Percentage of participants who dropped out of study by drug condition
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
|
Overall Study
COMPLETED
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
wanted more care
|
0
|
1
|
|
Overall Study
incarcerated
|
1
|
0
|
Baseline Characteristics
Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Baseline characteristics by cohort
| Measure |
1- Acamprosate
n=51 Participants
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
n=49 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
49 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPercentage of participants who dropped out of study by drug condition
Outcome measures
| Measure |
1- Acamprosate
n=51 Participants
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
n=49 Participants
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.
|
|---|---|---|
|
% Dropout
|
21.5 percentage of participants
|
16.3 percentage of participants
|
PRIMARY outcome
Timeframe: 12 weeks%Days without any alcohol consumption over the treatment period
Outcome measures
| Measure |
1- Acamprosate
n=51 Participants
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
n=49 Participants
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.
|
|---|---|---|
|
Percent Days Abstinent
|
40.7 percentage of days
Standard Deviation 30.6
|
41.6 percentage of days
Standard Deviation 33.0
|
SECONDARY outcome
Timeframe: 12 weeksNumber of individuals retained in the trial by acamprosate vs placebo group
Outcome measures
| Measure |
1- Acamprosate
n=51 Participants
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
n=49 Participants
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.
|
|---|---|---|
|
Retention
|
39 participants
|
41 participants
|
SECONDARY outcome
Timeframe: 12 weeks% of subjects with no drinking during the 12 week treatment trial
Outcome measures
| Measure |
1- Acamprosate
n=51 Participants
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
n=49 Participants
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.
|
|---|---|---|
|
Percent With Complete Abstinence
|
5.9 percentage of participants
|
19.1 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
1- Acamprosate
n=51 Participants
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
n=49 Participants
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.
|
|---|---|---|
|
% Heavy Drinking Days During Trial
|
15.8 percentage of heavy drinking days
Standard Deviation 21.3
|
18.4 percentage of heavy drinking days
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 12 weeksRange 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
Outcome measures
| Measure |
1- Acamprosate
n=51 Participants
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
n=49 Participants
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.
|
|---|---|---|
|
Clinical Global Impression Scale
|
2.3 units on a scale
Standard Deviation 0.9
|
2.4 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 12 weeks% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.
Outcome measures
| Measure |
1- Acamprosate
n=51 Participants
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
n=49 Participants
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.
|
|---|---|---|
|
% Compliant With Medication
|
93.3 percentage of participants
|
91.6 percentage of participants
|
Adverse Events
1- Acamprosate
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
2 - Sugar Pill - Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1- Acamprosate
n=51 participants at risk
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
n=49 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
17/51
|
24.5%
12/49
|
Additional Information
Dr. J.C. Garbutt
University of North Carolina at Chapel Hill
Phone: 919-966-4652
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60