Trial Outcomes & Findings for Acamprosate in Alcoholics With Comorbid Anxiety or Depression (NCT NCT00330174)
NCT ID: NCT00330174
Last Updated: 2015-04-13
Results Overview
Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.
COMPLETED
PHASE4
90 participants
12 weeks
2015-04-13
Participant Flow
Participants were recruited from May 2006 to June 2008. The study was conducted at three sites including a rural community treatment program in South Carolina, an urban community treatment program in New York City, and at an academic setting at McLean Hospital in Belmont, MA
Participant milestones
| Measure |
Acamprosate
Acamprosate tablets
|
Placebo
Matching placebo tablets
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
22
|
19
|
Reasons for withdrawal
| Measure |
Acamprosate
Acamprosate tablets
|
Placebo
Matching placebo tablets
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Clinical deterioration
|
1
|
2
|
|
Overall Study
Excessive missed visits
|
3
|
8
|
|
Overall Study
Miscellaneous reasons
|
7
|
1
|
Baseline Characteristics
Acamprosate in Alcoholics With Comorbid Anxiety or Depression
Baseline characteristics by cohort
| Measure |
Acamprosate
n=45 Participants
Acamprosate tablets
|
Placebo
n=45 Participants
Matching placebo tablets
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
44.6 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
44.1 years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
45 participants
n=107 Participants
|
90 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The primary outcome measure is difference in cumulative days abstinent. Based on the meta-analysis by Mann et al (2004). A total sample of 90 participants would be able to detect a difference of 11 (+/- 18) days between acamprosate and placebo groups with 80% power, and Type 1 error rate of 0.05.
Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.
Outcome measures
| Measure |
Acamprosate
n=45 Participants
Acamprosate tablets
|
Placebo
n=45 Participants
Matching placebo tablets
|
|---|---|---|
|
Percent Days Drinking
|
34.9 percentage of days drinking
Standard Error 0.04
|
31.9 percentage of days drinking
Standard Error 0.04
|
SECONDARY outcome
Timeframe: 12 weeksThis 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.
Outcome measures
| Measure |
Acamprosate
n=45 Participants
Acamprosate tablets
|
Placebo
n=45 Participants
Matching placebo tablets
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
11.0 units on a scale
Standard Error 0.79
|
11.5 units on a scale
Standard Error 0.76
|
SECONDARY outcome
Timeframe: 12 weeksThe LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.
Outcome measures
| Measure |
Acamprosate
n=45 Participants
Acamprosate tablets
|
Placebo
n=45 Participants
Matching placebo tablets
|
|---|---|---|
|
Liebowitz Social Anxiety Scale
|
22.5 units on a scale
Standard Error 3.09
|
23.2 units on a scale
Standard Error 30.5
|
SECONDARY outcome
Timeframe: 12 weeksThis is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.
Outcome measures
| Measure |
Acamprosate
n=45 Participants
Acamprosate tablets
|
Placebo
n=45 Participants
Matching placebo tablets
|
|---|---|---|
|
Hospital Anxiety and Depression Scale
|
10.5 units on a scale
Standard Error 0.87
|
9.4 units on a scale
Standard Error 0.84
|
Adverse Events
Acamprosate
Placebo
Serious adverse events
| Measure |
Acamprosate
n=45 participants at risk
Acamprosate tablets
|
Placebo
n=45 participants at risk
Matching placebo tablets
|
|---|---|---|
|
Psychiatric disorders
Clinical Deterioration
|
2.2%
1/45 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Acamprosate
n=45 participants at risk
Acamprosate tablets
|
Placebo
n=45 participants at risk
Matching placebo tablets
|
|---|---|---|
|
General disorders
Headache
|
28.9%
13/45 • Number of events 15
|
43.2%
16/37 • Number of events 20
|
|
Gastrointestinal disorders
Diarrhea
|
15.6%
7/45 • Number of events 7
|
22.2%
10/45 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
11.1%
5/45 • Number of events 5
|
11.1%
5/45 • Number of events 5
|
Additional Information
Susan Sonne, PharmD, BCPP
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place