Trial Outcomes & Findings for Pharmacogenetics, Emotional Reactivity and Smoking (NCT NCT00507728)
NCT ID: NCT00507728
Last Updated: 2021-05-06
Results Overview
Emotional reactivity measured by the peak eye blink electromyography (EMG) of the orbicularis oculi (ORB) muscle responses to acoustic startle probe delivered during the presentation of emotionally valent stimuli (pleasant, unpleasant, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
646 participants
Primary outcome timeframe
Baseline to 1 month
Results posted on
2021-05-06
Participant Flow
A total of 254 subjects were randomized (varenicline: 75; bupropion: 89; placebo: 90 between December 2005 through October 2010. All subjects were residing in the Greater Houston Area and the study was completed at UT MD Anderson Cancer Center.
646 participants signed consent, 392 were screen failures
Participant milestones
| Measure |
Varenicline
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
|---|---|---|---|
|
Randomization to Month 3
STARTED
|
75
|
89
|
90
|
|
Randomization to Month 3
COMPLETED
|
60
|
75
|
70
|
|
Randomization to Month 3
NOT COMPLETED
|
15
|
14
|
20
|
|
From 3 Months to 6 Months
STARTED
|
60
|
75
|
70
|
|
From 3 Months to 6 Months
COMPLETED
|
54
|
65
|
61
|
|
From 3 Months to 6 Months
NOT COMPLETED
|
6
|
10
|
9
|
Reasons for withdrawal
| Measure |
Varenicline
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
|---|---|---|---|
|
Randomization to Month 3
Lost to Follow-up
|
15
|
14
|
20
|
|
From 3 Months to 6 Months
Lost to Follow-up
|
6
|
10
|
9
|
Baseline Characteristics
Pharmacogenetics, Emotional Reactivity and Smoking
Baseline characteristics by cohort
| Measure |
Varenicline
n=75 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=89 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=90 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.5 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
44.5 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
45.7 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
44.6 Years
STANDARD_DEVIATION 10.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
89 participants
n=7 Participants
|
90 participants
n=5 Participants
|
254 participants
n=4 Participants
|
|
Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS)
WSWS Anger Subscale
|
3.8 Score on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
4.2 Score on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
4.2 Score on a scale
STANDARD_DEVIATION 7.9 • n=5 Participants
|
4.1 Score on a scale
STANDARD_DEVIATION 2.6 • n=4 Participants
|
|
Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS)
WSWS Anxiety Subscale
|
7.3 Score on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
7.3 Score on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
|
7.9 Score on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
7.5 Score on a scale
STANDARD_DEVIATION 3.1 • n=4 Participants
|
|
Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS)
WSWS Concentration Subscale
|
3.7 Score on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
4 Score on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
3.9 Score on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
3.9 Score on a scale
STANDARD_DEVIATION 2.1 • n=4 Participants
|
|
Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS)
WSWS Craving Subscale
|
8.7 Score on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
9.4 Score on a scale
STANDARD_DEVIATION 2.8 • n=7 Participants
|
9.1 Score on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
9.1 Score on a scale
STANDARD_DEVIATION 2.8 • n=4 Participants
|
|
Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS)
WSWS Hunger Subscale
|
9.6 Score on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
9.8 Score on a scale
STANDARD_DEVIATION 3.3 • n=7 Participants
|
11.2 Score on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
10.2 Score on a scale
STANDARD_DEVIATION 3.6 • n=4 Participants
|
|
Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS)
WSWS Sadness Subscale
|
4.6 Score on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
4.2 Score on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
4.7 Score on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
4.5 Score on a scale
STANDARD_DEVIATION 2.8 • n=4 Participants
|
|
Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS)
WSWS Sleep Subscale
|
7.7 Score on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
9.3 Score on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
8.6 Score on a scale
STANDARD_DEVIATION 4.4 • n=5 Participants
|
8.6 Score on a scale
STANDARD_DEVIATION 4.5 • n=4 Participants
|
|
Demographic and individual-level characteristics -Positive and Negative Affect Scales (PANAS)
PANAS Positive Affect
|
35.8 Score on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
36.1 Score on a scale
STANDARD_DEVIATION 5.7 • n=7 Participants
|
35.8 Score on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
35.9 Score on a scale
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
Demographic and individual-level characteristics -Positive and Negative Affect Scales (PANAS)
PANAS Negative Affect
|
14.8 Score on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
15.6 Score on a scale
STANDARD_DEVIATION 6.9 • n=7 Participants
|
16.4 Score on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
15.6 Score on a scale
STANDARD_DEVIATION 5.3 • n=4 Participants
|
|
Demographic and individual-level characteristics - (CESD)
|
6.7 Score on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
6.9 Score on a scale
STANDARD_DEVIATION 6.1 • n=7 Participants
|
8.1 Score on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
7.3 Score on a scale
STANDARD_DEVIATION 6.5 • n=4 Participants
|
|
Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ)
mCEQ Smoking Satisfaction
|
4.3 scores on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.9 scores on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
4.2 scores on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4.2 scores on a scale
STANDARD_DEVIATION 1.2 • n=4 Participants
|
|
Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ)
mCEQ Psychological Reward
|
4.1 scores on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
3.7 scores on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.6 scores on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
3.8 scores on a scale
STANDARD_DEVIATION 3.1 • n=4 Participants
|
|
Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ)
mCEQ Aversion
|
1.6 scores on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
1.6 scores on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
1.5 scores on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
1.5 scores on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants
|
|
Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ)
mCEQ Enjoyment of Respiratory Tract Sensation
|
2.9 scores on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
2.9 scores on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
2.9 scores on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
2.9 scores on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ)
mCEQ Craving Reduction
|
5.1 scores on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
5.1 scores on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
4.9 scores on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
5 scores on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 monthEmotional reactivity measured by the peak eye blink electromyography (EMG) of the orbicularis oculi (ORB) muscle responses to acoustic startle probe delivered during the presentation of emotionally valent stimuli (pleasant, unpleasant, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval.
Outcome measures
| Measure |
Varenicline
n=78 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=89 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=90 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Emotional Reactivity By Pharmacotherapy
Emotional Reactivity (ORB) to Cigarette Stimuli
|
66.6 microvolts
Interval 62.3 to 71.1
|
64.7 microvolts
Interval 60.9 to 68.5
|
65.6 microvolts
Interval 61.5 to 69.7
|
—
|
—
|
—
|
|
Emotional Reactivity By Pharmacotherapy
Emotional Reactivity (ORB) to Negative Stimuli
|
70.9 microvolts
Interval 66.4 to 75.4
|
73.1 microvolts
Interval 69.2 to 76.9
|
65.6 microvolts
Interval 61.5 to 69.7
|
—
|
—
|
—
|
|
Emotional Reactivity By Pharmacotherapy
Emotional Reactivity (ORB) to Positive Stimuli
|
66.7 microvolts
Interval 62.5 to 70.9
|
65.4 microvolts
Interval 61.8 to 68.9
|
64.7 microvolts
Interval 60.8 to 68.6
|
—
|
—
|
—
|
|
Emotional Reactivity By Pharmacotherapy
Emotional Reactivity (ORB) to Neutral Stimuli
|
59.6 microvolts
Interval 45.2 to 74.1
|
64.9 microvolts
Interval 52.7 to 77.2
|
72.5 microvolts
Interval 59.3 to 85.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 1 monthPopulation: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
The emotional reactivity (ORB EMG) of smokers during cessation will be moderated by genotype. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype.
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele
Emotional Reactivity (ORB) to Cigarette Stimuli
|
66.5 microvolts
Interval 61.1 to 71.9
|
69.9 microvolts
Interval 62.8 to 77.0
|
66.2 microvolts
Interval 60.4 to 72.0
|
66 microvolts
Interval 60.9 to 71.2
|
67.3 microvolts
Interval 61.5 to 73.1
|
68.1 microvolts
Interval 62.2 to 73.9
|
|
Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele
Emotional Reactivity (ORB) to Negative Stimuli
|
70.5 microvolts
Interval 65.0 to 75.9
|
75.1 microvolts
Interval 67.9 to 82.2
|
78.6 microvolts
Interval 72.8 to 84.4
|
71.3 microvolts
Interval 66.2 to 76.5
|
74 microvolts
Interval 68.2 to 79.7
|
68.1 microvolts
Interval 62.2 to 73.9
|
|
Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele
Emotional Reactivity (ORB) to Positive Stimuli
|
65.5 microvolts
Interval 60.4 to 70.6
|
72 microvolts
Interval 65.3 to 78.7
|
71.3 microvolts
Interval 65.8 to 76.7
|
63.3 microvolts
Interval 58.4 to
|
68.5 microvolts
Interval 63.1 to 74.0
|
63.8 microvolts
Interval 58.3 to 69.4
|
|
Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele
Emotional Reactivity (ORB) to Neutral Stimuli
|
55.3 microvolts
Interval 37.4 to 73.2
|
67.2 microvolts
Interval 43.0 to 91.5
|
73.9 microvolts
Interval 54.6 to 93.1
|
61.2 microvolts
Interval 44.0 to 78.3
|
79.7 microvolts
Interval 61.0 to 98.5
|
67.8 microvolts
Interval 48.3 to 87.2
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsValues represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.
Outcome measures
| Measure |
Varenicline
n=75 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=89 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=90 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Smoking Abstinence at 3 Months
Emotional Reactivity (ORB) to Neutral Stimuli
|
-0.004 probability
Interval -0.085 to 0.076
|
-0.008 probability
Interval -0.084 to 0.068
|
-0.007 probability
Interval -0.088 to 0.075
|
—
|
—
|
—
|
|
Smoking Abstinence at 3 Months
Emotional Reactivity (ORB) to Cigarette Stimuli
|
-0.003 probability
Interval -0.0777 to 0.072
|
-0.01 probability
Interval -0.084 to 0.065
|
-0.008 probability
Interval -0.096 to 0.081
|
—
|
—
|
—
|
|
Smoking Abstinence at 3 Months
Emotional Reactivity (ORB) to Negative Stimuli
|
-0.004 probability
Interval -0.081 to 0.073
|
-0.009 probability
Interval -0.076 to 0.058
|
-0.007 probability
Interval -0.088 to 0.073
|
—
|
—
|
—
|
|
Smoking Abstinence at 3 Months
Emotional Reactivity (ORB) to Positive Stimuli
|
-0.003 probability
Interval -0.081 to 0.076
|
-0.01 probability
Interval -0.084 to 0.064
|
-0.007 probability
Interval -0.092 to 0.079
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 MonthPopulation: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Smoking Abstinence at 3 Months by DRD2 A1 Allele
Emotional Reactivity (ORB) to Cigarette Stimuli
|
0.001 probability
Interval -0.002 to 0.004
|
-0.004 probability
Interval -0.008 to 0.0
|
0 probability
Interval -0.003 to 0.003
|
-0.003 probability
Interval -0.006 to 0.001
|
-0.001 probability
Interval -0.003 to 0.001
|
-0.004 probability
Interval -0.008 to 0.0
|
|
Smoking Abstinence at 3 Months by DRD2 A1 Allele
Emotional Reactivity (ORB) to Negative Stimuli
|
0.002 probability
Interval -0.002 to 0.005
|
-0.005 probability
Interval -0.008 to -0.001
|
0 probability
Interval -0.002 to 0.002
|
-0.004 probability
Interval -0.007 to 0.001
|
-0.001 probability
Interval -0.003 to 0.001
|
-0.004 probability
Interval -0.008 to 0.0
|
|
Smoking Abstinence at 3 Months by DRD2 A1 Allele
Emotional Reactivity (ORB) to Positive Stimuli
|
0.001 probability
Interval -0.002 to 0.005
|
-0.005 probability
Interval -0.009 to -0.001
|
0 probability
Interval -0.003 to 0.002
|
-0.003 probability
Interval -0.006 to 0.0
|
-0.001 probability
Interval -0.003 to 0.001
|
-0.004 probability
Interval -0.007 to 0.0
|
|
Smoking Abstinence at 3 Months by DRD2 A1 Allele
Emotional Reactivity (ORB) to Neutral Stimuli
|
0.001 probability
Interval -0.002 to 0.005
|
-0.005 probability
Interval -0.009 to -0.001
|
0.001 probability
Interval -0.002 to 0.003
|
-0.002 probability
Interval -0.005 to 0.001
|
-0.001 probability
Interval -0.003 to 0.001
|
-0.003 probability
Interval -0.007 to 0.001
|
SECONDARY outcome
Timeframe: Abstinence at 6 Months ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor)Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.
Outcome measures
| Measure |
Varenicline
n=75 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=89 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=90 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Smoking Abstinence at 6 Months
Emotional Reactivity (ORB) to Cigaretee Stimuli
|
0.007 probability
Interval -0.067 to 0.082
|
-0.002 probability
Interval -0.073 to 0.069
|
-0.006 probability
Interval -0.091 to 0.079
|
—
|
—
|
—
|
|
Smoking Abstinence at 6 Months
Emotional Reactivity (ORB) to Negative Stimuli
|
0.008 probability
Interval -0.069 to 0.085
|
-0.003 probability
Interval -0.067 to 0.062
|
-0.005 probability
Interval -0.081 to 0.071
|
—
|
—
|
—
|
|
Smoking Abstinence at 6 Months
Emotional Reactivity (ORB) to Positive Stimuli
|
0.01 probability
Interval -0.065 to 0.086
|
-0.003 probability
Interval -0.075 to 0.068
|
-0.005 probability
Interval -0.087 to 0.078
|
—
|
—
|
—
|
|
Smoking Abstinence at 6 Months
Emotional Reactivity (ORB) to Neutral Stimuli
|
0.008 probability
Interval -0.071 to 0.087
|
-0.001 probability
Interval -0.078 to 0.076
|
-0.005 probability
Interval -0.052 to 0.041
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 Month ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor)Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Abstinence at 6 Months by DRD2 A1 Allele
Emotional Reactivity (ORB) to Neutral Stimuli
|
0.003 probability
Interval 0.0 to 0.005
|
-0.001 probability
Interval -0.005 to 0.003
|
0.001 probability
Interval -0.002 to 0.004
|
-0.001 probability
Interval -0.004 to 0.002
|
0 probability
Interval -0.002 to 0.001
|
-0.004 probability
Interval -0.009 to 0.0
|
|
Abstinence at 6 Months by DRD2 A1 Allele
Emotional Reactivity (ORB) to Cigarette Stimuli
|
0.003 probability
Interval 0.0 to 0.005
|
-0.001 probability
Interval -0.005 to 0.003
|
0.001 probability
Interval -0.002 to 0.003
|
-0.001 probability
Interval -0.004 to 0.002
|
0 probability
Interval -0.002 to 0.001
|
-0.005 probability
Interval -0.01 to 0.0
|
|
Abstinence at 6 Months by DRD2 A1 Allele
Emotional Reactivity (ORB) to Negative Stimuli
|
0.003 probability
Interval 0.001 to 0.005
|
-0.001 probability
Interval -0.005 to 0.003
|
0.001 probability
Interval -0.001 to 0.003
|
-0.002 probability
Interval -0.005 to 0.001
|
0 probability
Interval -0.002 to 0.001
|
-0.004 probability
Interval -0.008 to 0.0
|
|
Abstinence at 6 Months by DRD2 A1 Allele
Emotional Reactivity (ORB) to Positive Stimuli
|
0.003 probability
Interval 0.001 to 0.006
|
0 probability
Interval -0.005 to 0.004
|
0 probability
Interval -0.002 to 0.003
|
-0.001 probability
Interval -0.004 to 0.002
|
0 probability
Interval -0.002 to 0.002
|
-0.004 probability
Interval -0.008 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 8 monthsPopulation: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
Symptoms of nicotine withdrawal measured using Wisconsin Smoking Withdrawal Scale (WSWS). The Wisconsin Withdrawal Scale (WSWS) contains 7 factors: Anger, Anxiety, Sadness, Concentration, Craving, Sleep, and Hunger. WSWS consists of 28 items that are scored on a 5-point Likert type scale (0 = strongly disagree, 4 = strongly agree). A single value was estimated by averaging within the specific time interval. Higher values represent worse outcome. The average value was estimated from Baseline to 8 months
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Anger
|
4.394 score on a scale
Interval 3.629 to 5.159
|
4.222 score on a scale
Interval 3.152 to 5.291
|
4.28 score on a scale
Interval 3.402 to 5.157
|
4.41 score on a scale
Interval 3.59 to 5.23
|
5.584 score on a scale
Interval 4.744 to 6.424
|
5.752 score on a scale
Interval 4.884 to 6.621
|
|
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Anxiety
|
6.218 score on a scale
Interval 5.384 to 7.052
|
5.873 score on a scale
Interval 4.707 to 7.038
|
6.587 score on a scale
Interval 5.63 to 7.543
|
6.587 score on a scale
Interval 5.63 to 7.543
|
7.785 score on a scale
Interval 6.87 to 8.7
|
7.915 score on a scale
Interval 6.968 to 8.862
|
|
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Concentration
|
3.743 score on a scale
Interval 3.117 to 4.369
|
3.407 score on a scale
Interval 2.531 to 4.282
|
4.238 score on a scale
Interval 3.521 to 4.956
|
3.935 score on a scale
Interval 3.265 to 4.605
|
4.764 score on a scale
Interval 4.077 to 5.451
|
4.951 score on a scale
Interval 4.242 to 5.66
|
|
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Craving
|
6.646 score on a scale
Interval 5.591 to 7.701
|
6.252 score on a scale
Interval 4.777 to 7.726
|
6.814 score on a scale
Interval 5.605 to 8.024
|
6.78 score on a scale
Interval 5.651 to 7.91
|
9.024 score on a scale
Interval 7.866 to 10.181
|
8.696 score on a scale
Interval 7.499 to 9.893
|
|
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Hunger
|
11.016 score on a scale
Interval 10.09 to 11.942
|
10.707 score on a scale
Interval 9.413 to 12.001
|
9.79 score on a scale
Interval 8.729 to 10.852
|
11.082 score on a scale
Interval 10.09 to 12.074
|
11.207 score on a scale
Interval 10.19 to 12.223
|
11.044 score on a scale
Interval 9.994 to 12.095
|
|
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Sadness
|
4.246 score on a scale
Interval 3.535 to 4.958
|
3.738 score on a scale
Interval 2.744 to 4.732
|
4.005 score on a scale
Interval 3.189 to 4.82
|
4.338 score on a scale
Interval 3.577 to 5.1
|
5.293 score on a scale
Interval 4.513 to 6.074
|
5.865 score on a scale
Interval 5.057 to 6.673
|
|
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Sleep
|
7.721 score on a scale
Interval 6.494 to 8.948
|
8.153 score on a scale
Interval 6.438 to 9.868
|
9.672 score on a scale
Interval 8.265 to 11.079
|
9.528 score on a scale
Interval 8.214 to 10.843
|
9.078 score on a scale
Interval 7.731 to 10.424
|
8.629 score on a scale
Interval 7.236 to 10.023
|
SECONDARY outcome
Timeframe: Baseline to 8 monthsPopulation: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
Symptoms of nicotine withdrawal and negative affect were measured using the Positive and Negative Affect Scale (PANAS). The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. The average value was estimated from Baseline to 8 months
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS)
Positive Affect
|
35.507 score on a scale
Interval 33.494 to 37.521
|
37.315 score on a scale
Interval 34.5 to 40.13
|
36.429 score on a scale
Interval 34.122 to 38.735
|
35.281 score on a scale
Interval 33.125 to 37.437
|
33.672 score on a scale
Interval 31.463 to 35.882
|
33.984 score on a scale
Interval 31.709 to 36.259
|
|
Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS)
Negative Affect
|
15.93 score on a scale
Interval 14.404 to 17.455
|
14.98 score on a scale
Interval 12.849 to 17.112
|
15.782 score on a scale
Interval 14.032 to 17.532
|
16.385 score on a scale
Interval 14.751 to 18.02
|
18.017 score on a scale
Interval 16.343 to 19.691
|
18.902 score on a scale
Interval 17.166 to 20.638
|
SECONDARY outcome
Timeframe: Baseline to 8 monthsPopulation: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
Symptoms of nicotine withdrawal measured using Center for Epidemiologic Studies Depression Scale (CES-D). Center of Epidemiologic Studies Depression Scale (CESD) a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The average value was estimated from Baseline to 8 months
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)
|
8.084 score on a scale
Interval 6.19 to 9.978
|
6.847 score on a scale
Interval 4.2 to 9.494
|
7.588 score on a scale
Interval 5.416 to 9.76
|
8.362 score on a scale
Interval 6.333 to 10.39
|
8.65 score on a scale
Interval 6.572 to 10.729
|
10.799 score on a scale
Interval 8.647 to 12.951
|
SECONDARY outcome
Timeframe: Baseline to 8 monthsPopulation: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
Modified Cigarette Evaluation Questionnaire (mCEQ). mCEQ Smoking satisfaction: range (1-21); mCEQ Psychological Reward: range(1-35); mCEQ Aversion: range (1-14); mCEQ Enjoyment of Resp.Tract Sens: range (1-7); mCEQ Craving Reduction: range (1-7). For all scales of mCEQ higher scores indicate worse outcomes (greater intensity of smoking effect). Scores of mCEQ Smoking satisfaction, mCEQ psychological reward and mCEQ aversion were summed to create the subscales. mCEQ Enjoyment of Resp Tract Sens and mCEQ Craving Reduction were single items.
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales
Smoking Satisfaction
|
2.895 score on a scale
Interval 1.912 to 3.879
|
2.591 score on a scale
Interval 1.253 to 3.93
|
4.064 score on a scale
Interval 2.94 to 5.187
|
3.369 score on a scale
Interval 2.135 to 4.603
|
3.025 score on a scale
Interval 2.087 to 3.963
|
3.515 score on a scale
Interval 2.368 to 4.662
|
|
Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales
Psychological Reward
|
2.819 score on a scale
Interval 2.109 to 3.528
|
2.155 score on a scale
Interval 1.181 to 3.13
|
2.519 score on a scale
Interval 1.693 to 3.346
|
2.723 score on a scale
Interval 1.812 to 3.634
|
3.575 score on a scale
Interval 2.861 to 4.289
|
3.246 score on a scale
Interval 2.399 to 4.093
|
|
Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales
Aversion
|
1.612 score on a scale
Interval 1.357 to 1.867
|
1.694 score on a scale
Interval 1.342 to 2.045
|
1.988 score on a scale
Interval 1.69 to 2.286
|
1.79 score on a scale
Interval 1.461 to 2.119
|
1.808 score on a scale
Interval 1.549 to 2.067
|
1.69 score on a scale
Interval 1.384 to 1.996
|
|
Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales
Enjoyment of Respiratory Tract Sensation
|
1.912 score on a scale
Interval 0.146 to 3.678
|
1.703 score on a scale
Interval -0.692 to 4.099
|
4.096 score on a scale
Interval 2.094 to 6.099
|
1.955 score on a scale
Interval -0.243 to 4.153
|
3.711 score on a scale
Interval 2.048 to 5.375
|
2.783 score on a scale
Interval 0.741 to 4.825
|
|
Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales
Craving Reduction
|
4.531 score on a scale
Interval 3.232 to 5.831
|
3.952 score on a scale
Interval 2.2 to 5.705
|
4.564 score on a scale
Interval 3.083 to 6.044
|
6.628 score on a scale
Interval 5.017 to 8.238
|
4.486 score on a scale
Interval 3.269 to 5.702
|
4.673 score on a scale
Interval 3.176 to 6.17
|
SECONDARY outcome
Timeframe: Baseline to 1 monthPopulation: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
Skin conductance response (SCR) amplitude measured by placing an electrodermal response transducer on the fore and ring fingers of the participants non-dominant hand, and heart rate (HR) was collected by placing a photoelectric pulse plethysmogram transducer on the middle finger of the participants non-dominant hand, during the presentation of emotionally valent stimuli (positive, negative, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval.
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Skin Conductance Response
Skin conductance to Cigarette Stimuli
|
2.301 Microsiemens
Interval 1.619 to 2.982
|
2.016 Microsiemens
Interval 1.132 to 2.901
|
2.275 Microsiemens
Interval 1.512 to 3.037
|
1.797 Microsiemens
Interval 1.082 to 2.511
|
2.272 Microsiemens
Interval 1.54 to 3.005
|
2.443 Microsiemens
Interval 1.703 to 3.183
|
|
Skin Conductance Response
Skin conductance to Negative Stimuli
|
2.295 Microsiemens
Interval 1.613 to 2.976
|
1.969 Microsiemens
Interval 1.084 to 2.855
|
2.31 Microsiemens
Interval 1.547 to 3.072
|
1.695 Microsiemens
Interval 0.999 to 2.391
|
2.355 Microsiemens
Interval 1.611 to 3.099
|
2.485 Microsiemens
Interval 1.756 to 3.215
|
|
Skin Conductance Response
Skin conductance to Positive Stimuli
|
2.256 Microsiemens
Interval 1.58 to 2.931
|
1.984 Microsiemens
Interval 1.106 to 2.862
|
2.299 Microsiemens
Interval 1.542 to 3.055
|
1.7 Microsiemens
Interval 1.01 to 2.39
|
2.296 Microsiemens
Interval 1.569 to 3.023
|
2.565 Microsiemens
Interval 1.831 to 3.299
|
|
Skin Conductance Response
Skin conductance to Neutral Stimuli
|
2.261 Microsiemens
Interval 1.578 to 2.944
|
2.017 Microsiemens
Interval 1.13 to 2.904
|
2.369 Microsiemens
Interval 1.602 to 3.136
|
1.699 Microsiemens
Interval 1.002 to 2.397
|
2.362 Microsiemens
Interval 1.616 to 3.107
|
2.559 Microsiemens
Interval 1.82 to 3.299
|
SECONDARY outcome
Timeframe: Baseline to 1 monthHeart Rate Response. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype.
Outcome measures
| Measure |
Varenicline
n=48 Participants
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=26 Participants
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=37 Participants
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
Bupropion With DRD2 A1 Allele
n=45 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
Placebo w/o DRD2 A1 Allele
n=41 Participants
Subjects in the Placebo group not carrying the DRD2 A1 allele
|
Placebo With DRD2 A1 Allele
n=44 Participants
Subjects in the Bupropion group carrying the DRD2 A1 allele
|
|---|---|---|---|---|---|---|
|
Heart Rate Response
Heart Rate response to Cigarette Stimuli
|
69.731 beats per minute
Interval 66.962 to 72.5
|
68.652 beats per minute
Interval 65.068 to 72.236
|
71.427 beats per minute
Interval 68.331 to 74.524
|
69.836 beats per minute
Interval 66.974 to 72.699
|
65.966 beats per minute
Interval 62.987 to 68.944
|
65.276 beats per minute
Interval 62.266 to 68.286
|
|
Heart Rate Response
Heart Rate response to Negative Stimuli
|
69.562 beats per minute
Interval 66.722 to 72.402
|
68.078 beats per minute
Interval 64.403 to 71.753
|
71.077 beats per minute
Interval 67.904 to 74.25
|
69.595 beats per minute
Interval 66.699 to 72.492
|
65.768 beats per minute
Interval 62.713 to 68.823
|
65.569 beats per minute
Interval 62.523 to 68.615
|
|
Heart Rate Response
Heart Rate response to Positive Stimuli
|
69.151 beats per minute
Interval 66.351 to 71.95
|
68.711 beats per minute
Interval 65.087 to 72.334
|
71.518 beats per minute
Interval 68.386 to 74.65
|
70.404 beats per minute
Interval 67.546 to 73.262
|
65.787 beats per minute
Interval 62.776 to 68.799
|
65.927 beats per minute
Interval 62.929 to 68.926
|
|
Heart Rate Response
Heart Rate response to Neutral Stimuli
|
69.621 beats per minute
Interval 66.798 to 72.444
|
68.969 beats per minute
Interval 65.315 to 72.624
|
71.706 beats per minute
Interval 68.546 to 74.865
|
70.234 beats per minute
Interval 67.351 to 73.117
|
65.237 beats per minute
Interval 62.2 to 68.273
|
66.04 beats per minute
Interval 62.981 to 69.098
|
Adverse Events
Varenicline
Serious events: 2 serious events
Other events: 63 other events
Deaths: 0 deaths
Bupropion
Serious events: 2 serious events
Other events: 69 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=75 participants at risk
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=89 participants at risk
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=90 participants at risk
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.7%
2/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Cardiac disorders
Chest pain - cardiac
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased Coughing
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
Other adverse events
| Measure |
Varenicline
n=75 participants at risk
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
|
Bupropion
n=89 participants at risk
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
|
Placebo
n=90 participants at risk
Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
ABSCESS
|
1.3%
1/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
Musculoskeletal and connective tissue disorders
ACCIDENTAL INJURY
|
0.00%
0/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
General disorders
APPETITE DECREASED
|
4.0%
3/75 • Baseline, up to 8 months
|
4.5%
4/89 • Baseline, up to 8 months
|
3.3%
3/90 • Baseline, up to 8 months
|
|
General disorders
APPETITE INCREASED
|
10.7%
8/75 • Baseline, up to 8 months
|
7.9%
7/89 • Baseline, up to 8 months
|
5.6%
5/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Abnormal Dreams
|
17.3%
13/75 • Baseline, up to 8 months
|
6.7%
6/89 • Baseline, up to 8 months
|
7.8%
7/90 • Baseline, up to 8 months
|
|
Immune system disorders
Allergic reaction
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Immune system disorders
Allergy, Seasonal
|
1.3%
1/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Anxiety Symptoms
|
6.7%
5/75 • Baseline, up to 8 months
|
5.6%
5/89 • Baseline, up to 8 months
|
14.4%
13/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
BLOOD IN STOOL
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Skin and subcutaneous tissue disorders
BRUISE
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
4.4%
4/90 • Baseline, up to 8 months
|
|
Eye disorders
Blurred vision
|
1.3%
1/75 • Baseline, up to 8 months
|
4.5%
4/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
General disorders
Body odor
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Nervous system disorders
Cerebrospinal fluid..
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Cardiac disorders
Chest pain - cardiac
|
1.3%
1/75 • Baseline, up to 8 months
|
4.5%
4/89 • Baseline, up to 8 months
|
12.2%
11/90 • Baseline, up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.3%
1/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
4.4%
4/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
Constipation
|
8.0%
6/75 • Baseline, up to 8 months
|
5.6%
5/89 • Baseline, up to 8 months
|
3.3%
3/90 • Baseline, up to 8 months
|
|
Endocrine disorders
DIABETES MELLITUS
|
0.00%
0/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
General disorders
Dehydration
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Depression
|
8.0%
6/75 • Baseline, up to 8 months
|
7.9%
7/89 • Baseline, up to 8 months
|
11.1%
10/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
8/75 • Baseline, up to 8 months
|
4.5%
4/89 • Baseline, up to 8 months
|
13.3%
12/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Disturbance in attention
|
9.3%
7/75 • Baseline, up to 8 months
|
7.9%
7/89 • Baseline, up to 8 months
|
13.3%
12/90 • Baseline, up to 8 months
|
|
General disorders
Dizziness
|
5.3%
4/75 • Baseline, up to 8 months
|
4.5%
4/89 • Baseline, up to 8 months
|
4.4%
4/90 • Baseline, up to 8 months
|
|
Nervous system disorders
Drowsiness
|
4.0%
3/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
5.6%
5/90 • Baseline, up to 8 months
|
|
General disorders
Dry mouth
|
1.3%
1/75 • Baseline, up to 8 months
|
3.4%
3/89 • Baseline, up to 8 months
|
7.8%
7/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.0%
6/75 • Baseline, up to 8 months
|
6.7%
6/89 • Baseline, up to 8 months
|
3.3%
3/90 • Baseline, up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Edema
|
4.0%
3/75 • Baseline, up to 8 months
|
4.5%
4/89 • Baseline, up to 8 months
|
5.6%
5/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Elevated mood
|
0.00%
0/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Emotional liability
|
2.7%
2/75 • Baseline, up to 8 months
|
3.4%
3/89 • Baseline, up to 8 months
|
4.4%
4/90 • Baseline, up to 8 months
|
|
Eye disorders
Eye irritation
|
2.7%
2/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
General disorders
Fatigue
|
5.3%
4/75 • Baseline, up to 8 months
|
5.6%
5/89 • Baseline, up to 8 months
|
10.0%
9/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
2/75 • Baseline, up to 8 months
|
4.5%
4/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
General disorders
Flushing
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
Gastritis
|
8.0%
6/75 • Baseline, up to 8 months
|
5.6%
5/89 • Baseline, up to 8 months
|
4.4%
4/90 • Baseline, up to 8 months
|
|
Endocrine disorders
Glucose intolerance
|
0.00%
0/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Nervous system disorders
Headache
|
12.0%
9/75 • Baseline, up to 8 months
|
14.6%
13/89 • Baseline, up to 8 months
|
12.2%
11/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Herniated Disc
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Cardiac disorders
Hypertension
|
4.0%
3/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Endocrine disorders
Hypothyroidism
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased Coughing
|
12.0%
9/75 • Baseline, up to 8 months
|
7.9%
7/89 • Baseline, up to 8 months
|
4.4%
4/90 • Baseline, up to 8 months
|
|
General disorders
Infection
|
1.3%
1/75 • Baseline, up to 8 months
|
6.7%
6/89 • Baseline, up to 8 months
|
3.3%
3/90 • Baseline, up to 8 months
|
|
General disorders
Influenza
|
8.0%
6/75 • Baseline, up to 8 months
|
9.0%
8/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
Nervous system disorders
Insomnia
|
21.3%
16/75 • Baseline, up to 8 months
|
29.2%
26/89 • Baseline, up to 8 months
|
14.4%
13/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Irritability
|
14.7%
11/75 • Baseline, up to 8 months
|
15.7%
14/89 • Baseline, up to 8 months
|
14.4%
13/90 • Baseline, up to 8 months
|
|
Renal and urinary disorders
Kidney Stones
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Reproductive system and breast disorders
Libido decreased
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
General disorders
Mucositis oral
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.3%
10/75 • Baseline, up to 8 months
|
10.1%
9/89 • Baseline, up to 8 months
|
13.3%
12/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
Nausea
|
28.0%
21/75 • Baseline, up to 8 months
|
19.1%
17/89 • Baseline, up to 8 months
|
8.9%
8/90 • Baseline, up to 8 months
|
|
General disorders
Neck pain
|
1.3%
1/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Nervous system disorders
PARESTHESIA
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
General disorders
Pain
|
1.3%
1/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
6.7%
6/90 • Baseline, up to 8 months
|
|
General disorders
Pelvic pain
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Reduced inhibition
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/75 • Baseline, up to 8 months
|
5.6%
5/89 • Baseline, up to 8 months
|
5.6%
5/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
22.7%
17/75 • Baseline, up to 8 months
|
29.2%
26/89 • Baseline, up to 8 months
|
25.6%
23/90 • Baseline, up to 8 months
|
|
Skin and subcutaneous tissue disorders
SWEATING INCREASED
|
0.00%
0/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
Nervous system disorders
Sensory disturbance
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
8.0%
6/75 • Baseline, up to 8 months
|
7.9%
7/89 • Baseline, up to 8 months
|
12.2%
11/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.7%
2/75 • Baseline, up to 8 months
|
3.4%
3/89 • Baseline, up to 8 months
|
10.0%
9/90 • Baseline, up to 8 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Surgical and medical procedures
Surgical and medical
|
1.3%
1/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
General disorders
TASTE PERVERSION
|
5.3%
4/75 • Baseline, up to 8 months
|
3.4%
3/89 • Baseline, up to 8 months
|
6.7%
6/90 • Baseline, up to 8 months
|
|
Musculoskeletal and connective tissue disorders
TREMOR
|
2.7%
2/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Cardiac disorders
Tachycardia/Palpita..
|
1.3%
1/75 • Baseline, up to 8 months
|
3.4%
3/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Tinnitus
|
0.00%
0/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
General disorders
Toothache
|
4.0%
3/75 • Baseline, up to 8 months
|
7.9%
7/89 • Baseline, up to 8 months
|
3.3%
3/90 • Baseline, up to 8 months
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Renal and urinary disorders
Urinary frequency
|
1.3%
1/75 • Baseline, up to 8 months
|
3.4%
3/89 • Baseline, up to 8 months
|
0.00%
0/90 • Baseline, up to 8 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/75 • Baseline, up to 8 months
|
1.1%
1/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
3/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
2.2%
2/90 • Baseline, up to 8 months
|
|
General disorders
Weight gain
|
2.7%
2/75 • Baseline, up to 8 months
|
2.2%
2/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
|
General disorders
Weight loss
|
0.00%
0/75 • Baseline, up to 8 months
|
0.00%
0/89 • Baseline, up to 8 months
|
1.1%
1/90 • Baseline, up to 8 months
|
Additional Information
Paul M Cinciripini, MD, Chair, Behavioral Science
UT MD Anderson Cancer Center
Phone: (713) 745-1868
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place