Trial Outcomes & Findings for Concurrent Bupropion / Varenicline for Smoking Cessation (NCT NCT01303861)
NCT ID: NCT01303861
Last Updated: 2014-08-06
Results Overview
The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
702 participants
Primary outcome timeframe
Study week 8 thru week 11
Results posted on
2014-08-06
Participant Flow
Recruitment began on 3/07/11 and ended on 11/30/12. Of the 702 subjects consented during this period, 218 were in our Charlotte, NC office, 157 were in our Durham, NC office, 151 were in our Raleigh, NC office and 176 were in our Winston-Salem, NC office. Only 349 subjects met all study criteria, and 22 discontinued prior to being assigned.
Participant milestones
| Measure |
Varenicline
This group will consist of smokers who, based on smoking behavior, Do NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
|
Nicotine Patches Only
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
|
Nicotine Patches With Nicotine Inhaler
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
|
Varenicline With Bupropion
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
109
|
50
|
55
|
113
|
|
Overall Study
Finished Treatment Phase
|
71
|
34
|
39
|
72
|
|
Overall Study
COMPLETED
|
51
|
25
|
19
|
54
|
|
Overall Study
NOT COMPLETED
|
58
|
25
|
36
|
59
|
Reasons for withdrawal
| Measure |
Varenicline
This group will consist of smokers who, based on smoking behavior, Do NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
|
Nicotine Patches Only
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
|
Nicotine Patches With Nicotine Inhaler
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
|
Varenicline With Bupropion
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
34
|
14
|
27
|
31
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
16
|
8
|
8
|
23
|
|
Overall Study
Adverse Event
|
4
|
1
|
0
|
5
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Concurrent Bupropion / Varenicline for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Varenicline
n=109 Participants
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
|
Nicotine Patches Only
n=50 Participants
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
|
Nicotine Patches With Nicotine Inhaler
n=55 Participants
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
|
Varenicline With Bupropion
n=113 Participants
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
|
Dropped Prior to Condition Assignment
n=22 Participants
These subjects discontinued study participation prior to being assigned to a condition.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 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
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
347 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Age, Continuous
|
45.58 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
45.20 years
STANDARD_DEVIATION 10.56 • n=7 Participants
|
42.09 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
44.22 years
STANDARD_DEVIATION 10.47 • n=4 Participants
|
44.77 years
STANDARD_DEVIATION 11.28 • n=21 Participants
|
44.42 years
STANDARD_DEVIATION 11.20 • n=8 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
195 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
154 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
340 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
121 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
210 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=5 Participants
|
50 participants
n=7 Participants
|
55 participants
n=5 Participants
|
113 participants
n=4 Participants
|
22 participants
n=21 Participants
|
349 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Study week 8 thru week 11Population: 1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.
The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.
Outcome measures
| Measure |
Varenicline
n=108 Participants
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
|
Nicotine Patches Only
n=49 Participants
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
|
Nicotine Patches With Nicotine Inhaler
n=55 Participants
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
|
Varenicline With Bupropion
n=113 Participants
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
|
|---|---|---|---|---|
|
Four-week Continuous Abstinence From Cigarette Smoking
|
25.93 percentage of participants
Interval 17.97 to 35.25
|
46.94 percentage of participants
Interval 32.53 to 61.73
|
43.64 percentage of participants
Interval 30.3 to 57.68
|
39.82 percentage of participants
Interval 30.73 to 49.46
|
SECONDARY outcome
Timeframe: Six months post quit datePopulation: 1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.
Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.
Outcome measures
| Measure |
Varenicline
n=108 Participants
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
|
Nicotine Patches Only
n=49 Participants
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
|
Nicotine Patches With Nicotine Inhaler
n=55 Participants
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
|
Varenicline With Bupropion
n=113 Participants
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
|
|---|---|---|---|---|
|
Seven Day Point Abstinence From Cigarette Smoking
|
18 participants
Interval 11.0 to 27.0
|
12 participants
Interval 7.0 to 19.0
|
6 participants
Interval 2.0 to 12.0
|
29 participants
Interval 20.0 to 39.0
|
SECONDARY outcome
Timeframe: From Quit date to end of treatment (week 11)Population: 1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.
Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).
Outcome measures
| Measure |
Varenicline
n=108 Participants
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
|
Nicotine Patches Only
n=49 Participants
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
|
Nicotine Patches With Nicotine Inhaler
n=55 Participants
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
|
Varenicline With Bupropion
n=113 Participants
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
|
|---|---|---|---|---|
|
Continuous Cigarette Abstinence From Quit Date
|
9 participants
Interval 4.0 to 16.0
|
13 participants
Interval 7.0 to 20.0
|
15 participants
Interval 9.0 to 23.0
|
17 participants
Interval 10.0 to 26.0
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
Nicotine Patches Only
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Nicotine Patches With Nicotine Inhaler
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Varenicline With Bupropion
Serious events: 0 serious events
Other events: 80 other events
Deaths: 0 deaths
Dropped Prior to Condition Assignment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=109 participants at risk
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
|
Nicotine Patches Only
n=50 participants at risk
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
|
Nicotine Patches With Nicotine Inhaler
n=55 participants at risk
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
|
Varenicline With Bupropion
n=113 participants at risk
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
|
Dropped Prior to Condition Assignment
n=22 participants at risk
These subjects discontinued study participation prior to being assigned to a condition.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tightness in Chest
|
0.00%
0/109 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
2.0%
1/50 • Number of events 1 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/55 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/113 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
Other adverse events
| Measure |
Varenicline
n=109 participants at risk
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
|
Nicotine Patches Only
n=50 participants at risk
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
|
Nicotine Patches With Nicotine Inhaler
n=55 participants at risk
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
|
Varenicline With Bupropion
n=113 participants at risk
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.
Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
|
Dropped Prior to Condition Assignment
n=22 participants at risk
These subjects discontinued study participation prior to being assigned to a condition.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
9.2%
10/109 • Number of events 12 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
10.0%
5/50 • Number of events 5 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
9.1%
5/55 • Number of events 5 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
8.0%
9/113 • Number of events 11 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal / Sinus Irritation
|
4.6%
5/109 • Number of events 5 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
8.0%
4/50 • Number of events 5 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.5%
3/55 • Number of events 3 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
6.2%
7/113 • Number of events 7 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
General disorders
Change in Taste
|
6.4%
7/109 • Number of events 11 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
22.0%
11/50 • Number of events 13 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
18.2%
10/55 • Number of events 15 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
18.6%
21/113 • Number of events 34 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
General disorders
Mouth / Throat Irritation
|
6.4%
7/109 • Number of events 11 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
8.0%
4/50 • Number of events 4 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
3.6%
2/55 • Number of events 3 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
2.7%
3/113 • Number of events 3 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
General disorders
Dry Mouth
|
6.4%
7/109 • Number of events 12 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
12.0%
6/50 • Number of events 8 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.5%
3/55 • Number of events 7 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
13.3%
15/113 • Number of events 24 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
General disorders
Thirst
|
12.8%
14/109 • Number of events 26 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
12.0%
6/50 • Number of events 13 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
12.7%
7/55 • Number of events 11 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
15.9%
18/113 • Number of events 30 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
11.0%
12/109 • Number of events 18 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
12.0%
6/50 • Number of events 9 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.5%
3/55 • Number of events 3 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.3%
6/113 • Number of events 7 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Metabolism and nutrition disorders
Joint / Muscle Pain
|
8.3%
9/109 • Number of events 13 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
12.0%
6/50 • Number of events 12 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.5%
3/55 • Number of events 7 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.3%
6/113 • Number of events 8 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
General disorders
Jaw / Neck Pain
|
3.7%
4/109 • Number of events 4 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
4.0%
2/50 • Number of events 3 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.5%
3/55 • Number of events 4 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.88%
1/113 • Number of events 1 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Gastrointestinal disorders
Heartburn
|
5.5%
6/109 • Number of events 9 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
6.0%
3/50 • Number of events 5 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
7.3%
4/55 • Number of events 4 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.3%
6/113 • Number of events 10 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Gastrointestinal disorders
Nausea
|
7.3%
8/109 • Number of events 10 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
10.0%
5/50 • Number of events 6 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
5.5%
3/55 • Number of events 4 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
3.5%
4/113 • Number of events 5 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Gastrointestinal disorders
Constipation
|
4.6%
5/109 • Number of events 9 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
2.0%
1/50 • Number of events 1 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
3.6%
2/55 • Number of events 2 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
8.0%
9/113 • Number of events 13 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Nervous system disorders
Irritability
|
11.9%
13/109 • Number of events 18 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
12.0%
6/50 • Number of events 7 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
9.1%
5/55 • Number of events 8 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
8.8%
10/113 • Number of events 15 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Nervous system disorders
Nightmares
|
6.4%
7/109 • Number of events 10 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
6.0%
3/50 • Number of events 4 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
1.8%
1/55 • Number of events 1 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
9.7%
11/113 • Number of events 13 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Nervous system disorders
Vivid Dreams
|
11.9%
13/109 • Number of events 20 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
40.0%
20/50 • Number of events 41 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
21.8%
12/55 • Number of events 23 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
21.2%
24/113 • Number of events 56 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Nervous system disorders
Insomnia
|
9.2%
10/109 • Number of events 15 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
28.0%
14/50 • Number of events 20 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
9.1%
5/55 • Number of events 6 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
15.9%
18/113 • Number of events 25 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Skin and subcutaneous tissue disorders
Itching at Patch Site
|
0.92%
1/109 • Number of events 1 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
24.0%
12/50 • Number of events 19 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
14.5%
8/55 • Number of events 12 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
1.8%
2/113 • Number of events 2 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
|
Nervous system disorders
Anxiety
|
0.00%
0/109 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
2.0%
1/50 • Number of events 1 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
12.7%
7/55 • Number of events 9 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.88%
1/113 • Number of events 2 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
0.00%
0/22 • Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.
|
Additional Information
Dr. Jed E. Rose
Duke University Medical Center - Duke Center for Smoking Cessation
Phone: 919-668-5055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place