Trial Outcomes & Findings for NAC for Treating Comorbid PTSD and SUD (NCT NCT02911285)
NCT ID: NCT02911285
Last Updated: 2021-05-19
Results Overview
Change in Alcohol Use Disorder Severity as measured by change in average drinking days per week from baseline to week 8. Greater reduction in drinking days indicates better treatment outcomes. Drinking days measured over 1 week periods (7 days). Scale ranges from 0 days to 7 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
From baseline to week 8 of treatment
Results posted on
2021-05-19
Participant Flow
Participant milestones
| Measure |
N-acetylcysteine (NAC) Plus Cognitive Behavioral Therapy (CBT)
Participants randomized to N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg bid (2400mg/day)
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
Placebo + Cognitive Behavioral Therapy (CBT)
Participants received placebo pills and Cognitive Behavioral Therapy (CBT) for 8 weeks.
Placebo: Placebo pills bid
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
41
|
|
Overall Study
COMPLETED
|
40
|
36
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
N-acetylcysteine (NAC) Plus Cognitive Behavioral Therapy (CBT)
Participants randomized to N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg bid (2400mg/day)
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
Placebo + Cognitive Behavioral Therapy (CBT)
Participants received placebo pills and Cognitive Behavioral Therapy (CBT) for 8 weeks.
Placebo: Placebo pills bid
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
|
Overall Study
Participant got a job and no longer had time to participate.
|
1
|
0
|
Baseline Characteristics
NAC for Treating Comorbid PTSD and SUD
Baseline characteristics by cohort
| Measure |
N-acetylcysteine + Cognitive Behavioral Therapy
n=49 Participants
Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg bid (2400mg/day)
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
Placebo + Cognitive Behavioral Therapy
n=41 Participants
Participants received placebo pills and CBT for 8 weeks.
Placebo: Placebo pills bid
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.99 Years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
49.13 Years
STANDARD_DEVIATION 13.23 • n=7 Participants
|
50.85 Years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 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
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
41 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 8 of treatmentChange in Alcohol Use Disorder Severity as measured by change in average drinking days per week from baseline to week 8. Greater reduction in drinking days indicates better treatment outcomes. Drinking days measured over 1 week periods (7 days). Scale ranges from 0 days to 7 days.
Outcome measures
| Measure |
N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)
n=40 Participants
Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg twice per day (2400mg/day)
Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week
|
Placebo and Cognitive Behavioral Therapy (CBT)
n=36 Participants
Participants received placebo pills and CBT for 8 weeks.
Placebo: Placebo pills twice per day
Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week
|
|---|---|---|
|
Change in Alcohol Use Disorder Severity
|
-2.65 drinking days reduction
Standard Deviation 3.85
|
-2.82 drinking days reduction
Standard Deviation 4.86
|
PRIMARY outcome
Timeframe: From baseline to week 8Change in post traumatic stress disorder severity as measured by Change in Clinician Administered PTSD Scale (CAPS-5) score from baseline to week 8. Greater change/reduction in score indicates better outcomes and greater reduction in PTSD symptomatology. (minimum score of 0 = absent to a maximum score of 80 = extreme)
Outcome measures
| Measure |
N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)
n=40 Participants
Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg twice per day (2400mg/day)
Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week
|
Placebo and Cognitive Behavioral Therapy (CBT)
n=36 Participants
Participants received placebo pills and CBT for 8 weeks.
Placebo: Placebo pills twice per day
Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week
|
|---|---|---|
|
Change in Post Traumatic Stress Disorder Severity
|
-6.93 score on a scale
Standard Deviation 13.42
|
-5.53 score on a scale
Standard Deviation 11.10
|
PRIMARY outcome
Timeframe: From baseline to week 8Population: 39 participants completed survey in NAC group and 37 participants completed survey in placebo group
Change in Alcohol craving as measured by change in Obsessive Compulsive Drinking Scale (OCDS) Total Score. Greater change/reduction in score indicates better outcomes and reduced alcohol craving. (Scores range from 0 to 56)
Outcome measures
| Measure |
N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)
n=39 Participants
Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg twice per day (2400mg/day)
Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week
|
Placebo and Cognitive Behavioral Therapy (CBT)
n=37 Participants
Participants received placebo pills and CBT for 8 weeks.
Placebo: Placebo pills twice per day
Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week
|
|---|---|---|
|
Change in Alcohol Craving
|
-3.97 score on a scale
Standard Deviation 7.26
|
-2.92 score on a scale
Standard Deviation 5.97
|
PRIMARY outcome
Timeframe: From baseline to week 8Population: 39 participants completed survey in NAC group, and 37 completed survey in placebo group
Post traumatic stress disorder symptoms as measured by change/reduction in score of post traumatic stress disorder checklist (PCL-5) from baseline to week 8. Greater reduction in score indicates better treatment outcomes. (minimum score of 0 = absent to a maximum score of 80 = extreme)
Outcome measures
| Measure |
N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)
n=39 Participants
Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg twice per day (2400mg/day)
Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week
|
Placebo and Cognitive Behavioral Therapy (CBT)
n=37 Participants
Participants received placebo pills and CBT for 8 weeks.
Placebo: Placebo pills twice per day
Cognitive behavioral therapy: for alcohol/substance use disorder, one hour/once a week
|
|---|---|---|
|
Change in Post Traumatic Stress Disorder Severity
|
-12.97 score on a scale
Standard Deviation 18.36
|
-9.97 score on a scale
Standard Deviation 16.75
|
Adverse Events
N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo and Cognitive Behavioral Therapy (CBT)
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)
n=49 participants at risk
Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg bid (2400mg/day)
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
Placebo and Cognitive Behavioral Therapy (CBT)
n=41 participants at risk
Participants received placebo pills and CBT for 8 weeks.
Placebo: Placebo pills bid
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/49 • Approximately 8-9 months.
|
2.4%
1/41 • Number of events 1 • Approximately 8-9 months.
|
|
Cardiac disorders
Congestive Heart Failure
|
2.0%
1/49 • Number of events 1 • Approximately 8-9 months.
|
0.00%
0/41 • Approximately 8-9 months.
|
|
Psychiatric disorders
Aborted Suicide Attempt
|
2.0%
1/49 • Number of events 1 • Approximately 8-9 months.
|
0.00%
0/41 • Approximately 8-9 months.
|
|
Hepatobiliary disorders
Liver Lesions
|
0.00%
0/49 • Approximately 8-9 months.
|
2.4%
1/41 • Number of events 1 • Approximately 8-9 months.
|
|
Blood and lymphatic system disorders
Severe Nose Bleed
|
2.0%
1/49 • Number of events 1 • Approximately 8-9 months.
|
0.00%
0/41 • Approximately 8-9 months.
|
Other adverse events
| Measure |
N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT)
n=49 participants at risk
Participants received N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.
N-acetylcysteine: 1200mg bid (2400mg/day)
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
Placebo and Cognitive Behavioral Therapy (CBT)
n=41 participants at risk
Participants received placebo pills and CBT for 8 weeks.
Placebo: Placebo pills bid
Cognitive behavioral therapy: CBT for AUD/SUD, one hour/once a week
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
12.2%
6/49 • Number of events 6 • Approximately 8-9 months.
|
7.3%
3/41 • Number of events 3 • Approximately 8-9 months.
|
|
General disorders
Fatigue
|
10.2%
5/49 • Number of events 5 • Approximately 8-9 months.
|
9.8%
4/41 • Number of events 4 • Approximately 8-9 months.
|
|
Gastrointestinal disorders
Flatulence
|
10.2%
5/49 • Number of events 5 • Approximately 8-9 months.
|
2.4%
1/41 • Number of events 1 • Approximately 8-9 months.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 1 • Approximately 8-9 months.
|
7.3%
3/41 • Number of events 3 • Approximately 8-9 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.1%
3/49 • Number of events 3 • Approximately 8-9 months.
|
9.8%
4/41 • Number of events 4 • Approximately 8-9 months.
|
|
Nervous system disorders
Headache
|
8.2%
4/49 • Number of events 4 • Approximately 8-9 months.
|
2.4%
1/41 • Number of events 1 • Approximately 8-9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
26.5%
13/49 • Number of events 13 • Approximately 8-9 months.
|
34.1%
14/41 • Number of events 14 • Approximately 8-9 months.
|
|
Metabolism and nutrition disorders
Appetite Changes
|
2.0%
1/49 • Number of events 1 • Approximately 8-9 months.
|
7.3%
3/41 • Number of events 3 • Approximately 8-9 months.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
2.0%
1/49 • Number of events 1 • Approximately 8-9 months.
|
9.8%
4/41 • Number of events 4 • Approximately 8-9 months.
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/49 • Number of events 1 • Approximately 8-9 months.
|
7.3%
3/41 • Number of events 3 • Approximately 8-9 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • Approximately 8-9 months.
|
7.3%
3/41 • Number of events 3 • Approximately 8-9 months.
|
Additional Information
Stacey Sellers, Program Manager
Medical University of South Carolina
Phone: 843-792-5807
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place