Trial Outcomes & Findings for Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers (NCT NCT01048944)
NCT ID: NCT01048944
Last Updated: 2014-11-25
Results Overview
Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second \[cps\]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, delta, alpha-1 and theta waves reflect deactivation of the brain activity, while higher frequency waves reflect greater brain activation. Brain activity was quantified as the natural log of EEG power \[microvolts squared\] as determined by the fast Fourier mathematical algorithm. Days post quit were components of Time. The primary focus was on changes in the individual subject's log theta-1, theta-2, and alpha-1 power at post-quit points in time minus the log values at the pre-quite baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
197 participants
Primary outcome timeframe
Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit
Results posted on
2014-11-25
Participant Flow
Recruitment: 9/01/06 to 9/01/11. Recruitment was throughout Carbondale and surrounding communities and occurred with newspaper ads, flyers, radio and television presentations. Recruitment was more challenging than expected because of the large time commitment and high prevalence of psychoactive medication and drug use (exclusionary criteria).
After consent subjects and the completion of their first experimental session subjects were randomly assigned to one of 4 treatment arms: 197 signed the consent, 126 completed the first experimental session and were subsequently randomly assigned to a treatment condition.
Participant milestones
| Measure |
Bupropion Sustained Release (SR)
150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.
|
Nicotine Patch
21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
|
Placebo Patch and Placebo Pill
Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days.
|
Delayed-quit Control
Smoke for 67 days while others have quit, then quit.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
38
|
35
|
21
|
|
Overall Study
COMPLETED
|
24
|
28
|
25
|
19
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
10
|
2
|
Reasons for withdrawal
| Measure |
Bupropion Sustained Release (SR)
150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.
|
Nicotine Patch
21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
|
Placebo Patch and Placebo Pill
Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days.
|
Delayed-quit Control
Smoke for 67 days while others have quit, then quit.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
8
|
10
|
10
|
2
|
Baseline Characteristics
Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
Baseline characteristics by cohort
| Measure |
Bupropion SR
n=32 Participants
150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.
|
Nicotine Patch
n=38 Participants
21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
|
Placebo Patch and Placebo Pill
n=35 Participants
Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days.
|
Delayed-quit Control
n=21 Participants
Smoke for 67 days while others have quit, then quit.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.85 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
30.84 years
STANDARD_DEVIATION 11.00 • n=7 Participants
|
31.49 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 10.42 • n=4 Participants
|
30.64 years
STANDARD_DEVIATION 10.97 • n=21 Participants
|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
38 participants
n=7 Participants
|
35 participants
n=5 Participants
|
21 participants
n=4 Participants
|
126 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quitPopulation: For the currently reported analyses, only individuals complying with the study requirements, including biochemically verified smoking abstinence, were assessed. Future analyses will include individuals who complied to certain critical endpoints.
Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second \[cps\]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, delta, alpha-1 and theta waves reflect deactivation of the brain activity, while higher frequency waves reflect greater brain activation. Brain activity was quantified as the natural log of EEG power \[microvolts squared\] as determined by the fast Fourier mathematical algorithm. Days post quit were components of Time. The primary focus was on changes in the individual subject's log theta-1, theta-2, and alpha-1 power at post-quit points in time minus the log values at the pre-quite baseline.
Outcome measures
| Measure |
Nicotine Patch
n=28 Participants
21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
|
Bupropion SR
n=24 Participants
150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.
|
Placebo Patch and Placebo Pill
n=25 Participants
Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days.
|
Delayed-quit Control
n=19 Participants
Smoke for 67 days while others have quit, then quit.
|
|---|---|---|---|---|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-3 Change in log Theta-1 EEG Power Fz
|
.055 Change in log EEG [microvolts squared]
Standard Error .061
|
.224 Change in log EEG [microvolts squared]
Standard Error .066
|
.234 Change in log EEG [microvolts squared]
Standard Error .066
|
-.094 Change in log EEG [microvolts squared]
Standard Error .071
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-24 Change in log Theta-1 EEG Power Fz
|
.194 Change in log EEG [microvolts squared]
Standard Error .068
|
.198 Change in log EEG [microvolts squared]
Standard Error .074
|
.258 Change in log EEG [microvolts squared]
Standard Error .074
|
-.060 Change in log EEG [microvolts squared]
Standard Error .080
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-45 Change in log Theta-1 Power Fz
|
.232 Change in log EEG [microvolts squared]
Standard Error .055
|
.249 Change in log EEG [microvolts squared]
Standard Error .060
|
.161 Change in log EEG [microvolts squared]
Standard Error .060
|
-.032 Change in log EEG [microvolts squared]
Standard Error .065
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-66 Change in log Theta-1 EEG Power Fz
|
.431 Change in log EEG [microvolts squared]
Standard Error .075
|
.407 Change in log EEG [microvolts squared]
Standard Error .081
|
.184 Change in log EEG [microvolts squared]
Standard Error .081
|
-.026 Change in log EEG [microvolts squared]
Standard Error .087
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-3 Change in log Theta-2 Power Fz
|
.062 Change in log EEG [microvolts squared]
Standard Error .077
|
.088 Change in log EEG [microvolts squared]
Standard Error .083
|
.249 Change in log EEG [microvolts squared]
Standard Error .083
|
-.070 Change in log EEG [microvolts squared]
Standard Error .090
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-24 Change in log Theta-2 Power Fz
|
.251 Change in log EEG [microvolts squared]
Standard Error .087
|
.150 Change in log EEG [microvolts squared]
Standard Error .094
|
.278 Change in log EEG [microvolts squared]
Standard Error .094
|
-.042 Change in log EEG [microvolts squared]
Standard Error .101
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-45 Change in log Theta-2 Power Fz
|
.319 Change in log EEG [microvolts squared]
Standard Error .074
|
.248 Change in log EEG [microvolts squared]
Standard Error .081
|
.278 Change in log EEG [microvolts squared]
Standard Error .094
|
.054 Change in log EEG [microvolts squared]
Standard Error .087
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-66 Change in log Theta-2 Power Fz
|
.504 Change in log EEG [microvolts squared]
Standard Error .092
|
.502 Change in log EEG [microvolts squared]
Standard Error .100
|
.205 Change in log EEG [microvolts squared]
Standard Error .100
|
.001 Change in log EEG [microvolts squared]
Standard Error .107
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-3 Change in log Alpha-1 Power Pz
|
-.023 Change in log EEG [microvolts squared]
Standard Error .103
|
.155 Change in log EEG [microvolts squared]
Standard Error .112
|
.184 Change in log EEG [microvolts squared]
Standard Error .112
|
-.004 Change in log EEG [microvolts squared]
Standard Error .121
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day-24 Change in log Alpha-1 Power Pz
|
.139 Change in log EEG [microvolts squared]
Standard Error .099
|
.301 Change in log EEG [microvolts squared]
Standard Error .107
|
.276 Change in log EEG [microvolts squared]
Standard Error .107
|
-.001 Change in log EEG [microvolts squared]
Standard Error .115
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day 45 Change in log Alpha-1 Power Pz
|
.292 Change in log EEG [microvolts squared]
Standard Error .099
|
.261 Change in log EEG [microvolts squared]
Standard Error .107
|
.259 Change in log EEG [microvolts squared]
Standard Error .107
|
.021 Change in log EEG [microvolts squared]
Standard Error .115
|
|
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Day 66 Change in log Alpha-1 Power Pz
|
.339 Change in log EEG [microvolts squared]
Standard Error .099
|
.459 Change in log EEG [microvolts squared]
Standard Error .107
|
.292 Change in log EEG [microvolts squared]
Standard Error .107
|
.017 Change in log EEG [microvolts squared]
Standard Error .116
|
PRIMARY outcome
Timeframe: Changes in log withdrawal symptoms from baseline through 66 days of abstinencePopulation: Analysis population included only those individuals who complied fully with study requirements through 67 days of abstinence.
Changes in log from baseline in the widely used Shiffman-Jarvik Withdrawal "craving" and "psychological symptom" scores through 66 days of abstinence. Post-quit changes were assessed at days 3, 24, 45, and 66 of abstinence. The maximal range of value raw for craving is from "5" = (no craving) to "47" (maximally strong craving), while that for psychological symptoms is from "5" (no symptoms) to "60" (maximally intense symptoms of across multiple symptoms). Because the subtraction of logs is equivalent to the ratio of the two scores, a difference in logs (base 10) with a value of "1" is equal to an increase by a factor of 10, while a value of "0" is no change, and values of less than "0" are decreases below baseline values.
Outcome measures
| Measure |
Nicotine Patch
n=28 Participants
21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
|
Bupropion SR
n=24 Participants
150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.
|
Placebo Patch and Placebo Pill
n=25 Participants
Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days.
|
Delayed-quit Control
n=19 Participants
Smoke for 67 days while others have quit, then quit.
|
|---|---|---|---|---|
|
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Day-66 Change in log Shiffman Craving
|
-.236 log (base 10) units on a scale
Standard Error .054
|
-.230 log (base 10) units on a scale
Standard Error .059
|
-.205 log (base 10) units on a scale
Standard Error .057
|
-.075 log (base 10) units on a scale
Standard Error .065
|
|
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Day-3 Change in log Shiffman Craving
|
-.006 log (base 10) units on a scale
Standard Error .038
|
.045 log (base 10) units on a scale
Standard Error .042
|
.094 log (base 10) units on a scale
Standard Error .040
|
-.045 log (base 10) units on a scale
Standard Error .046
|
|
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Day-24 Change in log Shiffman Craving
|
-.187 log (base 10) units on a scale
Standard Error .054
|
-.199 log (base 10) units on a scale
Standard Error .060
|
-.045 log (base 10) units on a scale
Standard Error .057
|
-.059 log (base 10) units on a scale
Standard Error .066
|
|
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Day-45 Change in log Shiffman Craving
|
-.273 log (base 10) units on a scale
Standard Error .047
|
-.201 log (base 10) units on a scale
Standard Error .052
|
-.132 log (base 10) units on a scale
Standard Error .050
|
-.043 log (base 10) units on a scale
Standard Error .057
|
|
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Day-3 Change in log Shiffman Psych Withdrawal
|
.089 log (base 10) units on a scale
Standard Error .032
|
.210 log (base 10) units on a scale
Standard Error .035
|
.172 log (base 10) units on a scale
Standard Error .034
|
.016 log (base 10) units on a scale
Standard Error .039
|
|
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Day-24 Change in log Shiffman Psych W
|
.065 log (base 10) units on a scale
Standard Error .031
|
.102 log (base 10) units on a scale
Standard Error .034
|
.076 log (base 10) units on a scale
Standard Error .033
|
-.025 log (base 10) units on a scale
Standard Error .038
|
|
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Day-45 Change in log Shiffman Psych Withdrawal
|
.008 log (base 10) units on a scale
Standard Error .031
|
.063 log (base 10) units on a scale
Standard Error .034
|
.039 log (base 10) units on a scale
Standard Error .033
|
-.017 log (base 10) units on a scale
Standard Error .038
|
|
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Day-66 Change in log Shiffman Psych Withdrawal
|
.068 log (base 10) units on a scale
Standard Error .037
|
.032 log (base 10) units on a scale
Standard Error .041
|
.029 log (base 10) units on a scale
Standard Error .039
|
-.012 log (base 10) units on a scale
Standard Error .045
|
Adverse Events
Bupropion SR
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Nicotine Patch
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo Patch and Placebo Pill
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Delayed-quit Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupropion SR
n=32 participants at risk
150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill, 3 days 1x/day then 56 days at 2x/day, then 3 day at 1x/day ramp-down.
|
Nicotine Patch
n=38 participants at risk
21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
|
Placebo Patch and Placebo Pill
n=35 participants at risk
Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56 days at 2x/day, then 3 days at 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days.
|
Delayed-quit Control
n=21 participants at risk
Smoke for 67 days while others have quit, then quit.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
40.6%
13/32 • Number of events 53 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
34.2%
13/38 • Number of events 34 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
25.7%
9/35 • Number of events 27 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
9.5%
2/21 • Number of events 2 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
|
Psychiatric disorders
Sleep disturbance
|
40.6%
13/32 • Number of events 42 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
39.5%
15/38 • Number of events 63 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
48.6%
17/35 • Number of events 54 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
9.5%
2/21 • Number of events 6 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
|
Nervous system disorders
Headaches
|
9.4%
3/32 • Number of events 7 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
7.9%
3/38 • Number of events 3 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
8.6%
3/35 • Number of events 4 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
14.3%
3/21 • Number of events 5 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
4/32 • Number of events 4 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
18.4%
7/38 • Number of events 12 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
5.7%
2/35 • Number of events 3 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
4.8%
1/21 • Number of events 1 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
|
Nervous system disorders
Dizzyness
|
9.4%
3/32 • Number of events 5 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
2.6%
1/38 • Number of events 6 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
14.3%
5/35 • Number of events 7 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
|
0.00%
0/21 • From the day of consent through one year after the 67-day post-quit treatment phase.
Questionnaires at approximately weekly intervals through one year after the 67-day post-quit treatment phase. Then every 3 months until a year after the study.
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Additional Information
David G. Gilbert, Ph.D.
Southern Illinois University Carbondale
Phone: 618-45303558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place