Trial Outcomes & Findings for Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers (NCT NCT01806779)
NCT ID: NCT01806779
Last Updated: 2016-01-18
Results Overview
This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
376 participants
Primary outcome timeframe
Period between 8-week and 11-week visits post target Quit Day
Results posted on
2016-01-18
Participant Flow
Recruitment began on 3/4/2013 and ended on 9/7/2014. Of the 376 subjects (subjs.) consented during this period, 197 subjects met all study criteria.
Of the 376 subjs. enrolled, 179 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1). 197 subjs. met all study criteria, attended V1 \& given NRT for 1 week; 176 subjs. attended V2 \& completed SE quest.; 2 subjs. dropped out during this visit before randomization; 174 subjs. randomized.
Participant milestones
| Measure |
Chantix
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Nicotine Patches Only
These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
84
|
23
|
|
Overall Study
Completed SE Quest. After Using Patches
|
90
|
84
|
2
|
|
Overall Study
Randomized at Visit 2
|
90
|
84
|
0
|
|
Overall Study
Completed SE Quest. After Randomization
|
87
|
83
|
0
|
|
Overall Study
COMPLETED
|
48
|
40
|
0
|
|
Overall Study
NOT COMPLETED
|
42
|
44
|
23
|
Reasons for withdrawal
| Measure |
Chantix
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Nicotine Patches Only
These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
19
|
20
|
0
|
|
Overall Study
Withdrawal by Subject
|
20
|
23
|
22
|
Baseline Characteristics
Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Baseline characteristics by cohort
| Measure |
Chantix
n=90 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
n=84 Participants
For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
174 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
44.75 years
STANDARD_DEVIATION 11.381 • n=93 Participants
|
43.12 years
STANDARD_DEVIATION 10.562 • n=4 Participants
|
43.96 years
STANDARD_DEVIATION 10.992 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
174 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
171 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
123 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=93 Participants
|
84 participants
n=4 Participants
|
174 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Period between 8-week and 11-week visits post target Quit DayThis will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Outcome measures
| Measure |
Chantix
n=90 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
n=84 Participants
For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
|---|---|---|
|
Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits
|
41 participants
|
38 participants
|
SECONDARY outcome
Timeframe: 6 months post Quit DayThis will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.
Outcome measures
| Measure |
Chantix
n=90 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
n=84 Participants
For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
|---|---|---|
|
Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day
|
21 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Quit Day to 11-week post Quit Day study visitThis will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Outcome measures
| Measure |
Chantix
n=90 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
n=84 Participants
For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
|---|---|---|
|
Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit
|
21 participants
|
15 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit DayPopulation: A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).
Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
Outcome measures
| Measure |
Chantix
n=77 Participants
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
n=76 Participants
For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
|---|---|---|
|
Change in Smoking Withdrawal Symptoms
Arousal -- % change 1 week from Quit Day
|
8.03 percentage of change
Standard Error 5.620
|
10.72 percentage of change
Standard Error 3.716
|
|
Change in Smoking Withdrawal Symptoms
Arousal -- % change 3 weeks from Quit Day
|
5.87 percentage of change
Standard Error 5.675
|
-4.40 percentage of change
Standard Error 3.643
|
|
Change in Smoking Withdrawal Symptoms
Arousal -- % change 7 weeks from Quit Day
|
6.94 percentage of change
Standard Error 6.763
|
-4.03 percentage of change
Standard Error 3.950
|
|
Change in Smoking Withdrawal Symptoms
Arousal -- % change 11 weeks from Quit Day
|
7.33 percentage of change
Standard Error 6.117
|
-1.56 percentage of change
Standard Error 3.928
|
|
Change in Smoking Withdrawal Symptoms
Craving -- % change 1 week from Quit Day
|
-18.15 percentage of change
Standard Error 2.354
|
-15.49 percentage of change
Standard Error 3.117
|
|
Change in Smoking Withdrawal Symptoms
Craving -- % change 3 weeks from Quit Day
|
-27.06 percentage of change
Standard Error 3.520
|
-28.64 percentage of change
Standard Error 4.439
|
|
Change in Smoking Withdrawal Symptoms
Craving -- % change 7 weeks from Quit Day
|
-30.94 percentage of change
Standard Error 3.124
|
-28.75 percentage of change
Standard Error 5.104
|
|
Change in Smoking Withdrawal Symptoms
Craving -- % change 11 weeks from Quit Day
|
-26.97 percentage of change
Standard Error 4.471
|
-30.82 percentage of change
Standard Error 5.201
|
|
Change in Smoking Withdrawal Symptoms
Craving -- % change 6 months from Quit Day
|
-42.96 percentage of change
Standard Error 6.563
|
-33.52 percentage of change
Standard Error 9.020
|
|
Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 1 week from Quit Day
|
-11.45 percentage of change
Standard Error 2.551
|
-7.15 percentage of change
Standard Error 2.791
|
|
Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 3 weeks from Quit Day
|
-9.74 percentage of change
Standard Error 2.494
|
-4.72 percentage of change
Standard Error 4.230
|
|
Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 7 weeks from Quit Day
|
-10.16 percentage of change
Standard Error 2.885
|
-10.88 percentage of change
Standard Error 4.177
|
|
Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 11 weeks from Quit Day
|
-15.06 percentage of change
Standard Error 3.396
|
-8.52 percentage of change
Standard Error 4.567
|
|
Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 6 months from Quit Day
|
-8.55 percentage of change
Standard Error 10.707
|
21.96 percentage of change
Standard Error 19.660
|
|
Change in Smoking Withdrawal Symptoms
Appetite -- % change 1 week from Quit Day
|
-10.53 percentage of change
Standard Error 3.148
|
-4.40 percentage of change
Standard Error 3.224
|
|
Change in Smoking Withdrawal Symptoms
Appetite -- % change 3 weeks from Quit Day
|
-11.04 percentage of change
Standard Error 5.065
|
-4.42 percentage of change
Standard Error 5.553
|
|
Change in Smoking Withdrawal Symptoms
Appetite -- % change 7 weeks from Quit Day
|
-9.30 percentage of change
Standard Error 5.981
|
-11.66 percentage of change
Standard Error 6.403
|
|
Change in Smoking Withdrawal Symptoms
Appetite -- % change 11 weeks from Quit Day
|
-16.20 percentage of change
Standard Error 7.153
|
-8.64 percentage of change
Standard Error 8.199
|
|
Change in Smoking Withdrawal Symptoms
Appetite -- % change 6 months from Quit Day
|
-33.88 percentage of change
Standard Error 10.872
|
-35.44 percentage of change
Standard Error 15.819
|
|
Change in Smoking Withdrawal Symptoms
Arousal -- % change 6 months from Quit Day
|
19.80 percentage of change
Standard Error 15.516
|
49.01 percentage of change
Standard Error 32.352
|
|
Change in Smoking Withdrawal Symptoms
Anxiety -- % change 1 week from Quit Day
|
-8.22 percentage of change
Standard Error 3.480
|
-12.26 percentage of change
Standard Error 2.780
|
|
Change in Smoking Withdrawal Symptoms
Anxiety -- % change 3 weeks from Quit Day
|
-8.66 percentage of change
Standard Error 4.001
|
-14.40 percentage of change
Standard Error 3.517
|
|
Change in Smoking Withdrawal Symptoms
Anxiety -- % change 7 weeks from Quit Day
|
-11.82 percentage of change
Standard Error 3.25
|
-12.50 percentage of change
Standard Error 5.000
|
|
Change in Smoking Withdrawal Symptoms
Anxiety -- % change 11 weeks from Quit Day
|
-9.34 percentage of change
Standard Error 3.526
|
-19.83 percentage of change
Standard Error 3.768
|
|
Change in Smoking Withdrawal Symptoms
Anxiety -- % change 6 months from Quit Day
|
-66.77 percentage of change
Standard Error 3.269
|
-57.15 percentage of change
Standard Error 6.064
|
|
Change in Smoking Withdrawal Symptoms
Gastrointestinal -- % change 1 week from Quit Day
|
-0.69 percentage of change
Standard Error 3.720
|
-7.78 percentage of change
Standard Error 2.692
|
|
Change in Smoking Withdrawal Symptoms
Gastrointestinal -- % change 3 weeks from Quit Day
|
-5.14 percentage of change
Standard Error 2.994
|
-10.07 percentage of change
Standard Error 2.791
|
|
Change in Smoking Withdrawal Symptoms
Gastrointestinal -- % change 7 weeks from Quit Day
|
-7.67 percentage of change
Standard Error 3.231
|
-8.44 percentage of change
Standard Error 4.777
|
|
Change in Smoking Withdrawal Symptoms
Gastrointestinal - % change 11 weeks from Quit Day
|
-8.05 percentage of change
Standard Error 3.357
|
-9.60 percentage of change
Standard Error 3.897
|
|
Change in Smoking Withdrawal Symptoms
Gastrointestinal - % change 6 months from Quit Day
|
-67.72 percentage of change
Standard Error 3.245
|
-56.61 percentage of change
Standard Error 6.026
|
|
Change in Smoking Withdrawal Symptoms
Respiratory -- % change 1 week from Quit Day
|
1.41 percentage of change
Standard Error 3.113
|
-7.47 percentage of change
Standard Error 2.887
|
|
Change in Smoking Withdrawal Symptoms
Respiratory -- % change 3 weeks from Quit Day
|
-1.12 percentage of change
Standard Error 4.694
|
-8.81 percentage of change
Standard Error 3.697
|
|
Change in Smoking Withdrawal Symptoms
Respiratory -- % change 7 weeks from Quit Day
|
0.92 percentage of change
Standard Error 6.534
|
-18.04 percentage of change
Standard Error 4.120
|
|
Change in Smoking Withdrawal Symptoms
Respiratory -- % change 11 weeks from Quit Day
|
-4.36 percentage of change
Standard Error 6.014
|
-19.67 percentage of change
Standard Error 4.507
|
|
Change in Smoking Withdrawal Symptoms
Respiratory -- % change 6 months from Quit Day
|
-65.87 percentage of change
Standard Error 3.293
|
-55.77 percentage of change
Standard Error 6.618
|
|
Change in Smoking Withdrawal Symptoms
Habit -- % change 1 week from Quit Day
|
-5.15 percentage of change
Standard Error 4.878
|
1.64 percentage of change
Standard Error 5.120
|
|
Change in Smoking Withdrawal Symptoms
Habit -- % change 3 weeks from Quit Day
|
-17.67 percentage of change
Standard Error 4.959
|
-16.07 percentage of change
Standard Error 3.735
|
|
Change in Smoking Withdrawal Symptoms
Habit -- % change 7 weeks from Quit Day
|
-14.46 percentage of change
Standard Error 6.666
|
-20.55 percentage of change
Standard Error 4.868
|
|
Change in Smoking Withdrawal Symptoms
Habit -- % change 11 weeks from Quit Day
|
-16.61 percentage of change
Standard Error 6.601
|
-24.78 percentage of change
Standard Error 6.085
|
|
Change in Smoking Withdrawal Symptoms
Habit -- % change 6 months from Quit Day
|
-56.97 percentage of change
Standard Error 4.807
|
-53.40 percentage of change
Standard Error 5.905
|
Adverse Events
Chantix
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Chantix + Zyban
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Nicotine Patch
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chantix
n=87 participants at risk；n=90 participants at risk
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
n=83 participants at risk；n=84 participants at risk
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Nicotine Patch
n=176 participants at risk；n=197 participants at risk
All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergic Reaction to Chantix or Zyban
|
0.00%
0/90 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
1.2%
1/84 • Number of events 1 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/197 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
General disorders
Non-cardiac Chest Pain & Right Ventricular Hypertrophy
|
1.1%
1/90 • Number of events 1 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/84 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/197 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Injury, poisoning and procedural complications
Jaw & upper extremity fracture due to an accident
|
1.1%
1/90 • Number of events 1 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/84 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/197 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Respiratory, thoracic and mediastinal disorders
COPD and reactive airway disease
|
1.1%
1/90 • Number of events 1 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/84 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/197 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
General disorders
Left sided weakness, headache, blurred vision
|
0.00%
0/90 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
1.2%
1/84 • Number of events 1 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/197 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
Other adverse events
| Measure |
Chantix
n=87 participants at risk；n=90 participants at risk
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Chantix + Zyban
n=83 participants at risk；n=84 participants at risk
For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
|
Nicotine Patch
n=176 participants at risk；n=197 participants at risk
All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
6.9%
6/87 • Number of events 6 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
6.0%
5/83 • Number of events 5 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
1.7%
3/176 • Number of events 3 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Nervous system disorders
Excessive Sweating
|
2.3%
2/87 • Number of events 3 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
8.4%
7/83 • Number of events 11 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
2.3%
4/176 • Number of events 4 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Nervous system disorders
Change in Taste
|
4.6%
4/87 • Number of events 6 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
20.5%
17/83 • Number of events 26 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
2.3%
4/176 • Number of events 4 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
General disorders
Dry Mouth
|
9.2%
8/87 • Number of events 13 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
13.3%
11/83 • Number of events 19 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
2.3%
4/176 • Number of events 4 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
General disorders
Thirst
|
6.9%
6/87 • Number of events 11 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
18.1%
15/83 • Number of events 32 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
5.7%
10/176 • Number of events 10 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Musculoskeletal and connective tissue disorders
Joint/Muscle/Back Pain
|
4.6%
4/87 • Number of events 10 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
7.2%
6/83 • Number of events 12 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
1.1%
2/176 • Number of events 2 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Nervous system disorders
Irritability
|
9.2%
8/87 • Number of events 12 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
13.3%
11/83 • Number of events 17 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
2.3%
4/176 • Number of events 4 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Nervous system disorders
Vivid Dreams
|
14.9%
13/87 • Number of events 29 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
22.9%
19/83 • Number of events 38 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
17.0%
30/176 • Number of events 30 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Nervous system disorders
Insomnia
|
8.0%
7/87 • Number of events 7 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
9.6%
8/83 • Number of events 17 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
6.2%
11/176 • Number of events 11 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Psychiatric disorders
Anxiety
|
3.4%
3/87 • Number of events 3 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
7.2%
6/83 • Number of events 6 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/176 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
General disorders
Decreased Libido
|
1.1%
1/87 • Number of events 1 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
6.0%
5/83 • Number of events 6 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
1.1%
2/176 • Number of events 2 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
|
Skin and subcutaneous tissue disorders
Itching/Burning at Patch Site
|
0.00%
0/87 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
0.00%
0/83 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
9.1%
16/176 • Number of events 16 • Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place