Trial Outcomes & Findings for Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients (NCT NCT01002105)
NCT ID: NCT01002105
Last Updated: 2017-01-27
Results Overview
Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.
COMPLETED
PHASE4
75 participants
one year
2017-01-27
Participant Flow
1/1/2009 - 31 /12/2010, 75 patients recruited from 15 outpatient centers. Of 75, 4 refused and 7 did not meet the inclusion criteria and 64 patients (48 male and 16 female) were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-bli
Participant milestones
| Measure |
Baclofen
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
Placebo, identical to baclofen was administered to the placebo group for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
19
|
21
|
Reasons for withdrawal
| Measure |
Baclofen
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
Placebo, identical to baclofen was administered to the placebo group for 12 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
16
|
|
Overall Study
non compliance
|
5
|
3
|
|
Overall Study
condition worsened
|
4
|
2
|
Baseline Characteristics
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Baseline characteristics by cohort
| Measure |
Baclofen
n=32 Participants
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
n=32 Participants
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Gender
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Alcohol intake in last six months
|
763.6 grams 40% alcohol/drinking day
STANDARD_DEVIATION 149.5 • n=5 Participants
|
831 grams 40% alcohol/drinking day
STANDARD_DEVIATION 151.0 • n=7 Participants
|
797.3 grams 40% alcohol/drinking day
STANDARD_DEVIATION 150.25 • n=5 Participants
|
PRIMARY outcome
Timeframe: one yearPercent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.
Outcome measures
| Measure |
Baclofen
n=13 Participants
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
n=11 Participants
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
|
|---|---|---|
|
Percent Abstinent Days
|
40 percentage of abstinent days
|
36 percentage of abstinent days
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeksUsed to evaluate self-reported alcohol craving. 14 items that provided a total (OCDS) as well as two subscale scores - obsessive drinking (OD) and compulsive drinking (CD). Each of the 14 items are scored from 0 to 4 with the inclusion of 4 split items with only the higher of the two scored items to be used in the total or subscale scores. The OCDS total score ranges from 0-40; the subscales both range from 0 to 20. On all scales, higher scores represent a worse outcome. Data for CD at 6 weeks not available to report
Outcome measures
| Measure |
Baclofen
n=32 Participants
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
n=32 Participants
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
|
|---|---|---|
|
Obsessive-Compulsive Drinking Scale Scores
OCDS at Baseline
|
28.7 units on a scale
Standard Deviation 9.8
|
28.6 units on a scale
Standard Deviation 12.3
|
|
Obsessive-Compulsive Drinking Scale Scores
OD at Baseline
|
11.4 units on a scale
Standard Deviation 4.8
|
11.1 units on a scale
Standard Deviation 5.1
|
|
Obsessive-Compulsive Drinking Scale Scores
CD at Baseline
|
17.3 units on a scale
Standard Deviation 6.8
|
17.6 units on a scale
Standard Deviation 7.7
|
|
Obsessive-Compulsive Drinking Scale Scores
OCDS at 6 weeks (n=21,26)
|
17.4 units on a scale
Standard Deviation 9.2
|
15.1 units on a scale
Standard Deviation 9.4
|
|
Obsessive-Compulsive Drinking Scale Scores
OD at 6 weeks (n=21,26)
|
6.9 units on a scale
Standard Deviation 4.3
|
6.1 units on a scale
Standard Deviation 3.8
|
|
Obsessive-Compulsive Drinking Scale Scores
OCDS at 12 weeks (n=17,23)
|
11.5 units on a scale
Standard Deviation 9.3
|
12.8 units on a scale
Standard Deviation 11.2
|
|
Obsessive-Compulsive Drinking Scale Scores
OD at 12 weeks (n=17,23)
|
4.5 units on a scale
Standard Deviation 3.9
|
4.6 units on a scale
Standard Deviation 4.3
|
|
Obsessive-Compulsive Drinking Scale Scores
CD at 12 weeks (n=17,23)
|
7.1 units on a scale
Standard Deviation 5.9
|
8.3 units on a scale
Standard Deviation 7.2
|
|
Obsessive-Compulsive Drinking Scale Scores
OCDS at 26 weeks (n=16,17)
|
11.1 units on a scale
Standard Deviation 10.1
|
7.9 units on a scale
Standard Deviation 8.6
|
|
Obsessive-Compulsive Drinking Scale Scores
OD at 26 weeks (n=16,17)
|
4.6 units on a scale
Standard Deviation 4.3
|
3.4 units on a scale
Standard Deviation 3.3
|
|
Obsessive-Compulsive Drinking Scale Scores
CD at 26 weeks (n=16,17)
|
6.5 units on a scale
Standard Deviation 6.6
|
4.3 units on a scale
Standard Deviation 5.5
|
|
Obsessive-Compulsive Drinking Scale Scores
OCDS at 52 weeks (n=13,12)
|
10.5 units on a scale
Standard Deviation 10.1
|
7.8 units on a scale
Standard Deviation 8.7
|
|
Obsessive-Compulsive Drinking Scale Scores
OD at 52 weeks (n=13,12)
|
4.3 units on a scale
Standard Deviation 4.1
|
3.4 units on a scale
Standard Deviation 3.4
|
|
Obsessive-Compulsive Drinking Scale Scores
CD at 52 weeks (n=13,12)
|
6.2 units on a scale
Standard Deviation 6.9
|
3.6 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeksThe General Health Questionnaire measures whether the respondent has recently experienced a particular symptom or behavior and ranges from 0-much less than usual to 3-much more than usual. Total scores range from 0 to 36 and vary by study population: total scores of about 11-12 are typical, and a score higher than 20 suggests severe problems and psychological distress.
Outcome measures
| Measure |
Baclofen
n=32 Participants
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
n=32 Participants
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
|
|---|---|---|
|
General Health Questionnaire
Baseline
|
17.7 units on a scale
Standard Deviation 5.7
|
18.0 units on a scale
Standard Deviation 6.2
|
|
General Health Questionnaire
Week 6 (n=21,26)
|
15.1 units on a scale
Standard Deviation 5.1
|
14.3 units on a scale
Standard Deviation 5.9
|
|
General Health Questionnaire
Week 12 (n=17,23)
|
13.2 units on a scale
Standard Deviation 5.2
|
15.8 units on a scale
Standard Deviation 7.1
|
|
General Health Questionnaire
Week 26 (n=16,17)
|
9.9 units on a scale
Standard Deviation 7.1
|
9.8 units on a scale
Standard Deviation 12.5
|
|
General Health Questionnaire
Week 52 (n=13,12)
|
10.1 units on a scale
Standard Deviation 9.2
|
7.2 units on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeksThe GSES measures one's belief in his/her ability to cope with stressful situations. The scale consists of 10 items (e.g. "Usually I am able to control a situation" or "In unexpected situations, I always know how I must behave myself"). Responses are rated on a 4- point Likert-scale ranging from "absolutely not true" (weighted as 1) to "absolutely true" (weighted as 4), where the higher GSES total scores indicate stronger self-efficacy beliefs.All responses are added to a sum score. The range is from 10 to 40 points with a higher score indicating more self-efficiency.
Outcome measures
| Measure |
Baclofen
n=32 Participants
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
n=32 Participants
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
|
|---|---|---|
|
General Self-Efficacy Scale
Baseline
|
25.4 units on a scale
Standard Deviation 6.9
|
23.6 units on a scale
Standard Deviation 8.3
|
|
General Self-Efficacy Scale
Week 6 (n=21,26)
|
24.1 units on a scale
Standard Deviation 5.8
|
23.6 units on a scale
Standard Deviation 6.6
|
|
General Self-Efficacy Scale
Week 12 (n=17,23)
|
27.8 units on a scale
Standard Deviation 6.9
|
25.6 units on a scale
Standard Deviation 6.0
|
|
General Self-Efficacy Scale
Week 26 (n=16,17)
|
27.1 units on a scale
Standard Deviation 7.2
|
27.4 units on a scale
Standard Deviation 6.9
|
|
General Self-Efficacy Scale
Week 52 (n=13,12)
|
25.8 units on a scale
Standard Deviation 5.3
|
26.5 units on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksThe MSPSS is a self-report instrument for assessment of emotional help and the level of satisfaction with the social support obtained from three sources - family, friends and significant others. The scale includes 12 items, each of which refer to the people to whom the respondent would turn if he/she had problems of a personal, health or family nature, as well as financial and employment problems. Responses are scored on a 7-point scale from 1 ('completely disagree') to 7 ('completely agree'). The MSPSS index and three subscales - family, friends and significant others - are computed. MSPSS total score ranged from 12 to 84, with a higher score indicating greater satisfaction with total support. Subscores ranged from 4 to 28, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Baclofen
n=32 Participants
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
n=32 Participants
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
|
|---|---|---|
|
Multidimensional Scale of Perceived Social Support
Total at Baseline
|
55.1 units on a scale
Standard Deviation 18.3
|
55.2 units on a scale
Standard Deviation 14.8
|
|
Multidimensional Scale of Perceived Social Support
Family at Baseline
|
19.4 units on a scale
Standard Deviation 5.9
|
18.2 units on a scale
Standard Deviation 6.7
|
|
Multidimensional Scale of Perceived Social Support
Friends at Baseline
|
15.6 units on a scale
Standard Deviation 8.3
|
16.8 units on a scale
Standard Deviation 6.6
|
|
Multidimensional Scale of Perceived Social Support
Others at Baseline
|
20.1 units on a scale
Standard Deviation 7.0
|
20.3 units on a scale
Standard Deviation 5.7
|
|
Multidimensional Scale of Perceived Social Support
Total at 52 weeks (n=13,12)
|
60.9 units on a scale
Standard Deviation 18.7
|
55.9 units on a scale
Standard Deviation 18.1
|
|
Multidimensional Scale of Perceived Social Support
Family at 52 weeks (n=13,12)
|
20.6 units on a scale
Standard Deviation 6.3
|
18.3 units on a scale
Standard Deviation 6.8
|
|
Multidimensional Scale of Perceived Social Support
Friends at 52 weeks (n=13,12)
|
18.3 units on a scale
Standard Deviation 7.6
|
18.2 units on a scale
Standard Deviation 5.5
|
|
Multidimensional Scale of Perceived Social Support
Others at 52 weeks (n=13,12)
|
20.8 units on a scale
Standard Deviation 6.3
|
19.2 units on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeksQuality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report form composed of 16 items, each rated on a 5-point scale that indicates the degree of enjoyment or satisfaction with: physical health; social relations; ability to function in daily life; ability to get around physically; mood; family relations; sexual drive and interest; ability to work on hobbies, work, leisure time activities; economic status; household activities; and living/housing situation. A total score of 1 to 15 items was computed while item 16 assessing "overall life satisfaction" was not included to avoid exaggerated scores. The total score was averaged from items 1 to 15 and ranged from 1 to 5, with higher scores indicating higher satisfaction.
Outcome measures
| Measure |
Baclofen
n=32 Participants
The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
Baclofen: Baclofen 50mg per day for 12 weeks
|
Placebo
n=32 Participants
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Baseline
|
2.8 units on a scale
Standard Deviation 0.8
|
2.8 units on a scale
Standard Deviation 1.0
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Week 6 (n=21,26)
|
3.1 units on a scale
Standard Deviation 0.8
|
3.2 units on a scale
Standard Deviation 0.9
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Week 12 (n=17,23)
|
3.4 units on a scale
Standard Deviation 0.7
|
3.4 units on a scale
Standard Deviation 0.8
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Week 26 (n=16,17)
|
3.4 units on a scale
Standard Deviation 0.6
|
3.6 units on a scale
Standard Deviation 0.9
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Week 52 (n=13,12)
|
3.4 units on a scale
Standard Deviation 0.8
|
3.6 units on a scale
Standard Deviation 0.7
|
Adverse Events
Baclofen
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Alexander Grinshpoon
Shaar Menashe Mental Health Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place