Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Baclofen to Reduce Alcohol Use in Veterans With HCV (BRAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008280
Recruitment Status : Completed
First Posted : November 5, 2009
Results First Posted : June 9, 2015
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Hepatitis C
Alcohol Use Disorders
Interventions Drug: baclofen
Drug: placebo
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Baclofen Placebo
Hide Arm/Group Description

baclofen 10 mg po tid

baclofen: baclofen 10 mg tid

placebo given tid

placebo: placebo pill tid

Period Title: Overall Study
Started 88 92
Completed 67 73
Not Completed 21 19
Arm/Group Title Baclofen Placebo Total
Hide Arm/Group Description

baclofen 10 mg po tid

baclofen: baclofen 10 mg tid

placebo given tid

placebo: placebo pill tid

Total of all reporting groups
Overall Number of Baseline Participants 88 92 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 92 participants 180 participants
55.7  (7.1) 57.5  (6.9) 56.6  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 92 participants 180 participants
Female
3
   3.4%
0
   0.0%
3
   1.7%
Male
85
  96.6%
92
 100.0%
177
  98.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 92 participants 180 participants
Hispanic or Latino
13
  14.8%
12
  13.0%
25
  13.9%
Not Hispanic or Latino
70
  79.5%
76
  82.6%
146
  81.1%
Unknown or Not Reported
5
   5.7%
4
   4.3%
9
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 92 participants 180 participants
American Indian or Alaska Native
1
   1.1%
2
   2.2%
3
   1.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.1%
1
   1.1%
2
   1.1%
Black or African American
31
  35.2%
35
  38.0%
66
  36.7%
White
52
  59.1%
50
  54.3%
102
  56.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   3.4%
4
   4.3%
7
   3.9%
1.Primary Outcome
Title Number of Drinking Days in the Past Two Weeks
Hide Description [Not Specified]
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baclofen Placebo
Hide Arm/Group Description:

baclofen 10 mg po tid

baclofen: baclofen 10 mg tid

placebo given tid

placebo: placebo pill tid

Overall Number of Participants Analyzed 88 92
Mean (Standard Error)
Unit of Measure: Number of Drinking Days/2 weeks
Baseline 8.6  (.50) 8.9  (.45)
Weeks 0-1 6.8  (.55) 7.1  (.54)
Weeks 2-3 6.2  (.55) 6.3  (.55)
Weeks 4-5 5.7  (.57) 5.8  (.58)
Weeks 6-7 5.4  (.57) 5.4  (.59)
Weeks 8-9 5.1  (.58) 4.8  (.59)
Weeks 10-11 4.6  (.55) 4.7  (.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinking days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wald Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinking days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Wald Chi-Squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time by group effects for the number of drinking days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Wald Chi-Squared
Comments [Not Specified]
2.Primary Outcome
Title Number of Drinks Consumed Per Two Week Segments
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baclofen Placebo
Hide Arm/Group Description:

baclofen 10 mg po tid

baclofen: baclofen 10 mg tid

placebo given tid

placebo: placebo pill tid

Overall Number of Participants Analyzed 88 92
Mean (Standard Error)
Unit of Measure: Number of Drinks/2 Weeks
Baseline 60.09  (5.04) 67.23  (5.09)
Weeks 0-1 41.89  (4.42) 47.68  (4.97)
Weeks 2-3 33.88  (4.32) 39.07  (4.52)
Weeks 4-5 28.46  (3.62) 37.73  (5.65)
Weeks 6-7 31.82  (5.54) 30.73  (5.04)
Weeks 8-9 26.01  (4.59) 26.69  (4.36)
Weeks 10-11 18.82  (2.67) 22.85  (3.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wald Chi-Squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Wald Chi-Squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of drinks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Wald Chi-Squared
Comments [Not Specified]
3.Primary Outcome
Title Number of Heavy Drinking Days Per Two Week Segment
Hide Description A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baclofen Placebo
Hide Arm/Group Description:

baclofen 10 mg po tid

baclofen: baclofen 10 mg tid

placebo given tid

placebo: placebo pill tid

Overall Number of Participants Analyzed 88 92
Mean (Standard Error)
Unit of Measure: Number of heavy drinking days/2 weeks
Baseline 6.48  (.53) 7.18  (.51)
Weeks 0-1 3.67  (.46) 4.04  (.46)
Weeks 2-3 2.59  (.37) 3.07  (.41)
Weeks 4-5 2.40  (.38) 3.29  (.50)
Weeks 6-7 2.52  (.46) 2.44  (.44)
Weeks 8-9 2.10  (.46) 2.18  (.42)
Weeks 10-11 1.37  (.31) 2.15  (.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of heavy drinking days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wald Chi-Squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of heavy drinking days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Wald Chi-Squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baclofen, Placebo
Comments This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of heavy drinking days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Wald Chi-Squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baclofen Placebo
Hide Arm/Group Description

baclofen 10 mg po tid

baclofen: baclofen 10 mg tid

placebo given tid

placebo: placebo pill tid

All-Cause Mortality
Baclofen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Baclofen Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/88 (6.82%)      3/92 (3.26%)    
Blood and lymphatic system disorders     
Hypotension [1]  0/88 (0.00%)  0 1/92 (1.09%)  1
Ear and labyrinth disorders     
Dizziness, Vertigo [2]  1/88 (1.14%)  1 0/92 (0.00%)  0
Gastrointestinal disorders     
GI Bleeding [3]  1/88 (1.14%)  1 0/92 (0.00%)  0
Injury, poisoning and procedural complications     
Tightness in the head and Chest [4]  1/88 (1.14%)  1 0/92 (0.00%)  0
Substance Abuse/Intoxication [5]  0/88 (0.00%)  0 1/92 (1.09%)  1
Alcohol Withdrawal Syndrome [6]  1/88 (1.14%)  1 0/92 (0.00%)  0
Psychiatric disorders     
Mental Status Change [7]  0/88 (0.00%)  0 1/92 (1.09%)  1
Altered Mental Status and Renal Failure [8]  1/88 (1.14%)  1 0/92 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Mild Chest Pressure [9]  1/88 (1.14%)  1 0/92 (0.00%)  0
[1]
subject was hospitalized for hypotension
[2]
Subject stopped taking study medication and was discontinued from the study.
[3]
Subject was admitted for GI bleeding, needed 8 bands in the esophagus.
[4]
Subject was hospitalized over night. Chest and head tightness was determined to be related to an epidural the patient received the day before.
[5]
Subject was hospitalized after suspected mix of alcohol and opiate drugs.
[6]
Subject was hospitalized for Alcohol Withdrawal
[7]
Subject had an increase in BDI-II (Beck Depression Inventory-II) depression scores and mental status change.
[8]
Subject was hospitalized two times, once for altered mental status and acute renal insufficiency, then again for alcohol withdrawal, hypertension and acute renal failure.
[9]
Subject had a preexisting history of chest pressure prior to participation in this study. Subject was withdrawn from the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baclofen Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/88 (79.55%)      68/92 (73.91%)    
Cardiac disorders     
Heart Palpitations  7/88 (7.95%)  6/92 (6.52%) 
Ear and labyrinth disorders     
Ringing in Ears  4/88 (4.55%)  8/92 (8.70%) 
Eye disorders     
Blurred Vision  9/88 (10.23%)  9/92 (9.78%) 
Double Vision  4/88 (4.55%)  3/92 (3.26%) 
Gastrointestinal disorders     
Diarrhea  8/88 (9.09%)  20/92 (21.74%) 
General disorders     
Abdominal Pain  12/88 (13.64%)  15/92 (16.30%) 
Confusion  20/88 (22.73%)  14/92 (15.22%) 
Constipation  14/88 (15.91%)  14/92 (15.22%) 
Difficulty Moving  10/88 (11.36%)  6/92 (6.52%) 
Dizziness  23/88 (26.14%)  21/92 (22.83%) 
Drowsiness  34/88 (38.64%)  30/92 (32.61%) 
Dry Mouth  14/88 (15.91%)  16/92 (17.39%) 
Excessive Perspiration  13/88 (14.77%)  10/92 (10.87%) 
Excitement  9/88 (10.23%)  11/92 (11.96%) 
Fatigue  10/88 (11.36%)  13/92 (14.13%) 
Headache  22/88 (25.00%)  18/92 (19.57%) 
Hypotension  7/88 (7.95%)  0/92 (0.00%) 
Itching  13/88 (14.77%)  9/92 (9.78%) 
Lack of Coordination  7/88 (7.95%)  11/92 (11.96%) 
Loss of Appetite  12/88 (13.64%)  17/92 (18.48%) 
Loss of Consciousness  4/88 (4.55%)  2/92 (2.17%) 
Nasal Congestion  11/88 (12.50%)  13/92 (14.13%) 
Nausea  14/88 (15.91%)  22/92 (23.91%) 
Paresthesia  11/88 (12.50%)  1/92 (1.09%) 
Problems Speaking  8/88 (9.09%)  9/92 (9.78%) 
Slurred Speech  9/88 (10.23%)  4/92 (4.35%) 
Swelling in Ankles  4/88 (4.55%)  2/92 (2.17%) 
Taste Disturbance  5/88 (5.68%)  5/92 (5.43%) 
Tremor  6/88 (6.82%)  7/92 (7.61%) 
Vomiting  8/88 (9.09%)  11/92 (11.96%) 
Weakness  13/88 (14.77%)  15/92 (16.30%) 
Weight Gain  11/88 (12.50%)  15/92 (16.30%) 
Musculoskeletal and connective tissue disorders     
Involuntary Muscle Movement  12/88 (13.64%)  9/92 (9.78%) 
Muscle Pain  11/88 (12.50%)  16/92 (17.39%) 
Muscle Stiffness  14/88 (15.91%)  11/92 (11.96%) 
Psychiatric disorders     
Depression  5/88 (5.68%)  14/92 (15.22%) 
Hallucinations  5/88 (5.68%)  3/92 (3.26%) 
Insomnia  8/88 (9.09%)  18/92 (19.57%) 
Renal and urinary disorders     
Bedwetting  5/88 (5.68%)  1/92 (1.09%) 
Urinary Frequency  11/88 (12.50%)  15/92 (16.30%) 
Urinary Retention  4/88 (4.55%)  5/92 (5.43%) 
Reproductive system and breast disorders     
Erectile Dysfunction  5/88 (5.68%)  7/92 (7.61%) 
Respiratory, thoracic and mediastinal disorders     
Difficulty Breathing at Night  10/88 (11.36%)  7/92 (7.61%) 
Skin and subcutaneous tissue disorders     
Rash  8/88 (9.09%)  3/92 (3.26%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Peter Hauser, MD, VISN 22 Mental Health Services Lead
Organization: VISN 22 Network Office
Phone: 562 826 8000 ext 2629
EMail: peter.hauser2@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01008280     History of Changes
Other Study ID Numbers: NURA-014-09S
First Submitted: November 3, 2009
First Posted: November 5, 2009
Results First Submitted: April 22, 2015
Results First Posted: June 9, 2015
Last Update Posted: February 8, 2016