Trial Outcomes & Findings for Baclofen to Reduce Alcohol Use in Veterans With HCV (NCT NCT01008280)
NCT ID: NCT01008280
Last Updated: 2016-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
12 Weeks
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
Baclofen
baclofen 10 mg po tid
baclofen: baclofen 10 mg tid
|
Placebo
placebo given tid
placebo: placebo pill tid
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
92
|
|
Overall Study
COMPLETED
|
67
|
73
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baclofen to Reduce Alcohol Use in Veterans With HCV
Baseline characteristics by cohort
| Measure |
Baclofen
n=88 Participants
baclofen 10 mg po tid
baclofen: baclofen 10 mg tid
|
Placebo
n=92 Participants
placebo given tid
placebo: placebo pill tid
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 Years
STANDARD_DEVIATION 7.1 • n=93 Participants
|
57.5 Years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
56.6 Years
STANDARD_DEVIATION 1.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
177 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
146 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksOutcome measures
| Measure |
Baclofen
n=88 Participants
baclofen 10 mg po tid
baclofen: baclofen 10 mg tid
|
Placebo
n=92 Participants
placebo given tid
placebo: placebo pill tid
|
|---|---|---|
|
Number of Drinking Days in the Past Two Weeks
Weeks 0-1
|
6.8 Number of Drinking Days/2 weeks
Standard Error .55
|
7.1 Number of Drinking Days/2 weeks
Standard Error .54
|
|
Number of Drinking Days in the Past Two Weeks
Weeks 2-3
|
6.2 Number of Drinking Days/2 weeks
Standard Error .55
|
6.3 Number of Drinking Days/2 weeks
Standard Error .55
|
|
Number of Drinking Days in the Past Two Weeks
Baseline
|
8.6 Number of Drinking Days/2 weeks
Standard Error .50
|
8.9 Number of Drinking Days/2 weeks
Standard Error .45
|
|
Number of Drinking Days in the Past Two Weeks
Weeks 4-5
|
5.7 Number of Drinking Days/2 weeks
Standard Error .57
|
5.8 Number of Drinking Days/2 weeks
Standard Error .58
|
|
Number of Drinking Days in the Past Two Weeks
Weeks 6-7
|
5.4 Number of Drinking Days/2 weeks
Standard Error .57
|
5.4 Number of Drinking Days/2 weeks
Standard Error .59
|
|
Number of Drinking Days in the Past Two Weeks
Weeks 8-9
|
5.1 Number of Drinking Days/2 weeks
Standard Error .58
|
4.8 Number of Drinking Days/2 weeks
Standard Error .59
|
|
Number of Drinking Days in the Past Two Weeks
Weeks 10-11
|
4.6 Number of Drinking Days/2 weeks
Standard Error .55
|
4.7 Number of Drinking Days/2 weeks
Standard Error .63
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Baclofen
n=88 Participants
baclofen 10 mg po tid
baclofen: baclofen 10 mg tid
|
Placebo
n=92 Participants
placebo given tid
placebo: placebo pill tid
|
|---|---|---|
|
Number of Drinks Consumed Per Two Week Segments
Weeks 10-11
|
18.82 Number of Drinks/2 Weeks
Standard Error 2.67
|
22.85 Number of Drinks/2 Weeks
Standard Error 3.71
|
|
Number of Drinks Consumed Per Two Week Segments
Baseline
|
60.09 Number of Drinks/2 Weeks
Standard Error 5.04
|
67.23 Number of Drinks/2 Weeks
Standard Error 5.09
|
|
Number of Drinks Consumed Per Two Week Segments
Weeks 0-1
|
41.89 Number of Drinks/2 Weeks
Standard Error 4.42
|
47.68 Number of Drinks/2 Weeks
Standard Error 4.97
|
|
Number of Drinks Consumed Per Two Week Segments
Weeks 2-3
|
33.88 Number of Drinks/2 Weeks
Standard Error 4.32
|
39.07 Number of Drinks/2 Weeks
Standard Error 4.52
|
|
Number of Drinks Consumed Per Two Week Segments
Weeks 4-5
|
28.46 Number of Drinks/2 Weeks
Standard Error 3.62
|
37.73 Number of Drinks/2 Weeks
Standard Error 5.65
|
|
Number of Drinks Consumed Per Two Week Segments
Weeks 6-7
|
31.82 Number of Drinks/2 Weeks
Standard Error 5.54
|
30.73 Number of Drinks/2 Weeks
Standard Error 5.04
|
|
Number of Drinks Consumed Per Two Week Segments
Weeks 8-9
|
26.01 Number of Drinks/2 Weeks
Standard Error 4.59
|
26.69 Number of Drinks/2 Weeks
Standard Error 4.36
|
PRIMARY outcome
Timeframe: 12 weeksA heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male
Outcome measures
| Measure |
Baclofen
n=88 Participants
baclofen 10 mg po tid
baclofen: baclofen 10 mg tid
|
Placebo
n=92 Participants
placebo given tid
placebo: placebo pill tid
|
|---|---|---|
|
Number of Heavy Drinking Days Per Two Week Segment
Weeks 2-3
|
2.59 Number of heavy drinking days/2 weeks
Standard Error .37
|
3.07 Number of heavy drinking days/2 weeks
Standard Error .41
|
|
Number of Heavy Drinking Days Per Two Week Segment
Weeks 4-5
|
2.40 Number of heavy drinking days/2 weeks
Standard Error .38
|
3.29 Number of heavy drinking days/2 weeks
Standard Error .50
|
|
Number of Heavy Drinking Days Per Two Week Segment
Weeks 8-9
|
2.10 Number of heavy drinking days/2 weeks
Standard Error .46
|
2.18 Number of heavy drinking days/2 weeks
Standard Error .42
|
|
Number of Heavy Drinking Days Per Two Week Segment
Baseline
|
6.48 Number of heavy drinking days/2 weeks
Standard Error .53
|
7.18 Number of heavy drinking days/2 weeks
Standard Error .51
|
|
Number of Heavy Drinking Days Per Two Week Segment
Weeks 0-1
|
3.67 Number of heavy drinking days/2 weeks
Standard Error .46
|
4.04 Number of heavy drinking days/2 weeks
Standard Error .46
|
|
Number of Heavy Drinking Days Per Two Week Segment
Weeks 6-7
|
2.52 Number of heavy drinking days/2 weeks
Standard Error .46
|
2.44 Number of heavy drinking days/2 weeks
Standard Error .44
|
|
Number of Heavy Drinking Days Per Two Week Segment
Weeks 10-11
|
1.37 Number of heavy drinking days/2 weeks
Standard Error .31
|
2.15 Number of heavy drinking days/2 weeks
Standard Error .46
|
Adverse Events
Baclofen
Serious events: 6 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Baclofen
n=88 participants at risk
baclofen 10 mg po tid
baclofen: baclofen 10 mg tid
|
Placebo
n=92 participants at risk
placebo given tid
placebo: placebo pill tid
|
|---|---|---|
|
Ear and labyrinth disorders
Dizziness, Vertigo
|
1.1%
1/88 • Number of events 1
|
0.00%
0/92
|
|
Psychiatric disorders
Mental Status Change
|
0.00%
0/88
|
1.1%
1/92 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tightness in the head and Chest
|
1.1%
1/88 • Number of events 1
|
0.00%
0/92
|
|
Gastrointestinal disorders
GI Bleeding
|
1.1%
1/88 • Number of events 1
|
0.00%
0/92
|
|
Injury, poisoning and procedural complications
Substance Abuse/Intoxication
|
0.00%
0/88
|
1.1%
1/92 • Number of events 1
|
|
Psychiatric disorders
Altered Mental Status and Renal Failure
|
1.1%
1/88 • Number of events 1
|
0.00%
0/92
|
|
Injury, poisoning and procedural complications
Alcohol Withdrawal Syndrome
|
1.1%
1/88 • Number of events 1
|
0.00%
0/92
|
|
Blood and lymphatic system disorders
Hypotension
|
0.00%
0/88
|
1.1%
1/92 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Mild Chest Pressure
|
1.1%
1/88 • Number of events 1
|
0.00%
0/92
|
Other adverse events
| Measure |
Baclofen
n=88 participants at risk
baclofen 10 mg po tid
baclofen: baclofen 10 mg tid
|
Placebo
n=92 participants at risk
placebo given tid
placebo: placebo pill tid
|
|---|---|---|
|
General disorders
Abdominal Pain
|
13.6%
12/88
|
16.3%
15/92
|
|
Renal and urinary disorders
Bedwetting
|
5.7%
5/88
|
1.1%
1/92
|
|
Eye disorders
Blurred Vision
|
10.2%
9/88
|
9.8%
9/92
|
|
General disorders
Confusion
|
22.7%
20/88
|
15.2%
14/92
|
|
General disorders
Constipation
|
15.9%
14/88
|
15.2%
14/92
|
|
Psychiatric disorders
Depression
|
5.7%
5/88
|
15.2%
14/92
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
8/88
|
21.7%
20/92
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Breathing at Night
|
11.4%
10/88
|
7.6%
7/92
|
|
General disorders
Difficulty Moving
|
11.4%
10/88
|
6.5%
6/92
|
|
General disorders
Dizziness
|
26.1%
23/88
|
22.8%
21/92
|
|
Eye disorders
Double Vision
|
4.5%
4/88
|
3.3%
3/92
|
|
General disorders
Drowsiness
|
38.6%
34/88
|
32.6%
30/92
|
|
General disorders
Dry Mouth
|
15.9%
14/88
|
17.4%
16/92
|
|
General disorders
Excessive Perspiration
|
14.8%
13/88
|
10.9%
10/92
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
5.7%
5/88
|
7.6%
7/92
|
|
General disorders
Excitement
|
10.2%
9/88
|
12.0%
11/92
|
|
General disorders
Fatigue
|
11.4%
10/88
|
14.1%
13/92
|
|
Psychiatric disorders
Hallucinations
|
5.7%
5/88
|
3.3%
3/92
|
|
General disorders
Headache
|
25.0%
22/88
|
19.6%
18/92
|
|
Cardiac disorders
Heart Palpitations
|
8.0%
7/88
|
6.5%
6/92
|
|
General disorders
Hypotension
|
8.0%
7/88
|
0.00%
0/92
|
|
Psychiatric disorders
Insomnia
|
9.1%
8/88
|
19.6%
18/92
|
|
General disorders
Itching
|
14.8%
13/88
|
9.8%
9/92
|
|
General disorders
Lack of Coordination
|
8.0%
7/88
|
12.0%
11/92
|
|
General disorders
Loss of Appetite
|
13.6%
12/88
|
18.5%
17/92
|
|
General disorders
Loss of Consciousness
|
4.5%
4/88
|
2.2%
2/92
|
|
Musculoskeletal and connective tissue disorders
Involuntary Muscle Movement
|
13.6%
12/88
|
9.8%
9/92
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
12.5%
11/88
|
17.4%
16/92
|
|
Musculoskeletal and connective tissue disorders
Muscle Stiffness
|
15.9%
14/88
|
12.0%
11/92
|
|
General disorders
Nasal Congestion
|
12.5%
11/88
|
14.1%
13/92
|
|
General disorders
Nausea
|
15.9%
14/88
|
23.9%
22/92
|
|
General disorders
Paresthesia
|
12.5%
11/88
|
1.1%
1/92
|
|
General disorders
Problems Speaking
|
9.1%
8/88
|
9.8%
9/92
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
8/88
|
3.3%
3/92
|
|
Ear and labyrinth disorders
Ringing in Ears
|
4.5%
4/88
|
8.7%
8/92
|
|
General disorders
Slurred Speech
|
10.2%
9/88
|
4.3%
4/92
|
|
General disorders
Swelling in Ankles
|
4.5%
4/88
|
2.2%
2/92
|
|
General disorders
Taste Disturbance
|
5.7%
5/88
|
5.4%
5/92
|
|
General disorders
Tremor
|
6.8%
6/88
|
7.6%
7/92
|
|
Renal and urinary disorders
Urinary Frequency
|
12.5%
11/88
|
16.3%
15/92
|
|
Renal and urinary disorders
Urinary Retention
|
4.5%
4/88
|
5.4%
5/92
|
|
General disorders
Vomiting
|
9.1%
8/88
|
12.0%
11/92
|
|
General disorders
Weakness
|
14.8%
13/88
|
16.3%
15/92
|
|
General disorders
Weight Gain
|
12.5%
11/88
|
16.3%
15/92
|
Additional Information
Peter Hauser, MD, VISN 22 Mental Health Services Lead
VISN 22 Network Office
Phone: 562 826 8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place