Trial Outcomes & Findings for N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI (NCT NCT02791945)
NCT ID: NCT02791945
Last Updated: 2021-05-11
Results Overview
The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
N-acetylcysteine
N-acetylcysteine capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
N-acetylcysteine: Experimental supplement
|
Placebo
Placebo capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
Baseline characteristics by cohort
| Measure |
N-acetylcysteine
n=14 Participants
N-acetylcysteine capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
N-acetylcysteine: Experimental supplement
|
Placebo
n=16 Participants
Placebo capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
Placebo: Placebo comparator
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
49 Years
STANDARD_DEVIATION 8 • n=93 Participants
|
54 Years
STANDARD_DEVIATION 10 • n=4 Participants
|
52 Years
STANDARD_DEVIATION 9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 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
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
16 participants
n=4 Participants
|
30 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.
Outcome measures
| Measure |
N-acetylcysteine
n=12 Participants
N-acetylcysteine capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
N-acetylcysteine: Experimental supplement
|
Placebo
n=14 Participants
Placebo capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB)
|
26.2 change in percent heavy drinking days/wk
Standard Deviation 0.31
|
26.5 change in percent heavy drinking days/wk
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: Baseline to Week 8Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater (more severe) the symptoms
Outcome measures
| Measure |
N-acetylcysteine
n=9 Participants
N-acetylcysteine capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
N-acetylcysteine: Experimental supplement
|
Placebo
n=14 Participants
Placebo capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI)
|
11.44 scores on a scale
Standard Deviation 10.09
|
10 scores on a scale
Standard Deviation 10.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 8The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.
Outcome measures
| Measure |
N-acetylcysteine
n=12 Participants
N-acetylcysteine capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
N-acetylcysteine: Experimental supplement
|
Placebo
n=14 Participants
Placebo capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB)
|
24.75 Standard drinks per week
Standard Deviation 25.6
|
18.45 Standard drinks per week
Standard Deviation 30.1
|
Adverse Events
N-acetylcysteine
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
N-acetylcysteine
n=14 participants at risk
N-acetylcysteine capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
N-acetylcysteine: Experimental supplement
|
Placebo
n=16 participants at risk
Placebo capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Inpatient hospitalization for self-reported "broken back in 3 places".
|
7.1%
1/14 • Number of events 1 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
0.00%
0/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Psychiatric disorders
Inpatient hospitalization/5150 (<72 hours) for suicidal threats while intoxicated
|
7.1%
1/14 • Number of events 1 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
0.00%
0/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
Other adverse events
| Measure |
N-acetylcysteine
n=14 participants at risk
N-acetylcysteine capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
N-acetylcysteine: Experimental supplement
|
Placebo
n=16 participants at risk
Placebo capsules daily - up to 3200 mg
Medical Management Counseling: Brief alcohol counseling
Placebo: Placebo comparator
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.1%
1/14 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
25.0%
4/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Skin and subcutaneous tissue disorders
Itching
|
42.9%
6/14 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
12.5%
2/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
4/14 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
18.8%
3/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/14 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
18.8%
3/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
31.2%
5/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
0.00%
0/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Gastrointestinal disorders
Upset stomach
|
21.4%
3/14 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
31.2%
5/16 • Over 12 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 8 and 12), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
Additional Information
Dr. Steven L. Batki, MD
University of California, San Francisco/San Francisco VA Healthcare System
Phone: 415-221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place