Trial Outcomes & Findings for N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers (NCT NCT00967005)
NCT ID: NCT00967005
Last Updated: 2023-03-21
Results Overview
Week 0 corresponds to baseline. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.
COMPLETED
PHASE2
28 participants
Week 0
2023-03-21
Participant Flow
Participant milestones
| Measure |
N Acetyl Cysteine
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
Sugar Pill: placebo control
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
Treatment Completion
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
N Acetyl Cysteine
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
Sugar Pill: placebo control
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
Baseline Characteristics
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
Baseline characteristics by cohort
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
47.7 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
47.6 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0Week 0 corresponds to baseline. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
|
23.5 units on a scale
Standard Deviation 6.4
|
20.4 units on a scale
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: Week 6Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
|
17.4 units on a scale
Standard Deviation 9.1
|
16.3 units on a scale
Standard Deviation 7.4
|
PRIMARY outcome
Timeframe: Week 12Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
|
7.5 units on a scale
Standard Deviation 4.6
|
5.5 units on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Week 24Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
|
1.0 units on a scale
Standard Deviation 1.3
|
6.4 units on a scale
Standard Deviation 6.2
|
PRIMARY outcome
Timeframe: Week 0Week 0 corresponds to baseline. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
|
11.8 units on a scale
Standard Deviation 3.7
|
9.0 units on a scale
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: Week 6Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
|
8.9 units on a scale
Standard Deviation 4.2
|
7.9 units on a scale
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Week 12Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
|
5.5 units on a scale
Standard Deviation 2.3
|
2.7 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Week 24Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
|
0.8 units on a scale
Standard Deviation 1.2
|
3.6 units on a scale
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Week 0Week 0 corresponds to baseline. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
|
11.7 units on a scale
Standard Deviation 3.7
|
11.4 units on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Week 6Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. . Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
|
8.5 units on a scale
Standard Deviation 5.7
|
8.3 units on a scale
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Week 12Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
|
2.0 units on a scale
Standard Deviation 3.1
|
2.8 units on a scale
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Week 24Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
|
0.2 units on a scale
Standard Deviation 0.4
|
2.8 units on a scale
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Week 0Week 0 corresponds to baseline. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Fagerstrom Test for Nicotine Dependence Total Score
|
6.5 units on a scale
Standard Deviation 2.0
|
6.7 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Week 6Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Fagerstrom Test for Nicotine Dependence Total Score
|
4.0 units on a scale
Standard Deviation 1.9
|
5.9 units on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Week 12Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Fagerstrom Test for Nicotine Dependence Total Score
|
5.3 units on a scale
Standard Deviation 2.9
|
5.0 units on a scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Week 24Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Fagerstrom Test for Nicotine Dependence Total Score
|
4.6 units on a scale
Standard Deviation 1.3
|
5.3 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Week 0Week 0 corresponds to baseline. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Hamilton Depression Rating Scale Total Score
|
9.7 units on a scale
Standard Deviation 5.7
|
7.9 units on a scale
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Week 6Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Hamilton Depression Rating Scale Total Score
|
7.5 units on a scale
Standard Deviation 4.7
|
5.5 units on a scale
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Week 12Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Hamilton Depression Rating Scale Total Score
|
7.0 units on a scale
Standard Deviation 4.9
|
3.7 units on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Week 24Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Hamilton Depression Rating Scale Total Score
|
2.8 units on a scale
Standard Deviation 2.1
|
3.5 units on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Week 0Week 0 corresponds to baseline. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Hamilton Anxiety Rating Scale Total Score
|
11.1 units on a scale
Standard Deviation 10.8
|
9.7 units on a scale
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: Week 6Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Hamilton Anxiety Rating Scale Total Score
|
7.5 units on a scale
Standard Deviation 4.3
|
6.2 units on a scale
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: Week 12Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Hamilton Anxiety Rating Scale Total Score
|
7.4 units on a scale
Standard Deviation 3.2
|
4.2 units on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Week 24Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.
Outcome measures
| Measure |
N Acetyl Cysteine
n=13 Participants
The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.
N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
|
Sugar Pill
n=15 Participants
Sugar Pill: placebo control
|
|---|---|---|
|
Hamilton Anxiety Rating Scale Total Score
|
5.0 units on a scale
Standard Deviation 3.6
|
6.5 units on a scale
Standard Deviation 5.2
|
Adverse Events
N Acetyl Cysteine
Sugar Pill
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place