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N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers

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: NCT00967005
Recruitment Status : Completed
First Posted : August 27, 2009
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Minnesota
Information provided by (Responsible Party):
Jon Grant, University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Gambling
Tobacco Use Disorder
Interventions Drug: N Acetyl Cysteine
Other: Sugar Pill
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description

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: placebo control
Period Title: Overall Study
Started 13 15
Treatment Completion 10 10
Completed 6 5
Not Completed 7 10
Reason Not Completed
Lost to Follow-up             7             10
Arm/Group Title N Acetyl Cysteine Sugar Pill Total
Hide Arm/Group Description

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: placebo control Total of all reporting groups
Overall Number of Baseline Participants 13 15 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 15 participants 28 participants
47.5  (10.1) 47.7  (10.6) 47.6  (10.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
15
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Female
2
  15.4%
3
  20.0%
5
  17.9%
Male
11
  84.6%
12
  80.0%
23
  82.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 15 participants 28 participants
13 15 28
1.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
Hide Description 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.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.5  (6.4) 20.4  (5.0)
2.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
Hide Description Week 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.4  (9.1) 16.3  (7.4)
3.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
Hide Description Week 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.5  (4.6) 5.5  (5.9)
4.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score
Hide Description Week 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.0  (1.3) 6.4  (6.2)
5.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
Hide Description Week 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.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.8  (3.7) 9.0  (3.4)
6.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
Hide Description Week 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.9  (4.2) 7.9  (3.8)
7.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
Hide Description Week 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.5  (2.3) 2.7  (2.1)
8.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale
Hide Description Week 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.8  (1.2) 3.6  (3.6)
9.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
Hide Description Week 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.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.7  (3.7) 11.4  (2.8)
10.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
Hide Description Week 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.5  (5.7) 8.3  (4.9)
11.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
Hide Description Week 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (3.1) 2.8  (4.5)
12.Primary Outcome
Title Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale
Hide Description Week 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (0.4) 2.8  (4.1)
13.Primary Outcome
Title Fagerstrom Test for Nicotine Dependence Total Score
Hide Description Week 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.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.5  (2.0) 6.7  (2.1)
14.Primary Outcome
Title Fagerstrom Test for Nicotine Dependence Total Score
Hide Description Week 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (1.9) 5.9  (2.4)
15.Primary Outcome
Title Fagerstrom Test for Nicotine Dependence Total Score
Hide Description Week 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.3  (2.9) 5.0  (1.5)
16.Primary Outcome
Title Fagerstrom Test for Nicotine Dependence Total Score
Hide Description Week 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.6  (1.3) 5.3  (1.2)
17.Primary Outcome
Title Hamilton Depression Rating Scale Total Score
Hide Description Week 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.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.7  (5.7) 7.9  (4.8)
18.Primary Outcome
Title Hamilton Depression Rating Scale Total Score
Hide Description Week 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.5  (4.7) 5.5  (3.8)
19.Primary Outcome
Title Hamilton Depression Rating Scale Total Score
Hide Description Week 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.0  (4.9) 3.7  (3.2)
20.Primary Outcome
Title Hamilton Depression Rating Scale Total Score
Hide Description Week 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (2.1) 3.5  (1.7)
21.Primary Outcome
Title Hamilton Anxiety Rating Scale Total Score
Hide Description Week 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.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.1  (10.8) 9.7  (6.6)
22.Primary Outcome
Title Hamilton Anxiety Rating Scale Total Score
Hide Description Week 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.5  (4.3) 6.2  (4.0)
23.Primary Outcome
Title Hamilton Anxiety Rating Scale Total Score
Hide Description Week 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.4  (3.2) 4.2  (3.2)
24.Primary Outcome
Title Hamilton Anxiety Rating Scale Total Score
Hide Description Week 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description:

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: placebo control
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (3.6) 6.5  (5.2)
Time Frame Adverse events were collected over the entire 12 weeks each of the subjects were enrolled in the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N Acetyl Cysteine Sugar Pill
Hide Arm/Group Description

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: placebo control
All-Cause Mortality
N Acetyl Cysteine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
N Acetyl Cysteine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N Acetyl Cysteine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/15 (0.00%) 
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: Dr. Marc N. Potenza, M.D., Ph.D.
Organization: Yale University
Phone: 203-737-3553
EMail: marc.potenza@yale.edu
Layout table for additonal information
Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT00967005    
Other Study ID Numbers: 0908M70981
1RC1DA028279-01 ( U.S. NIH Grant/Contract )
First Submitted: August 25, 2009
First Posted: August 27, 2009
Results First Submitted: April 3, 2017
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017