Trial Outcomes & Findings for Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms (NCT NCT00332644)
NCT ID: NCT00332644
Last Updated: 2011-11-30
Results Overview
Smoking status was assessed both as 7-day point-prevalence abstinence ("Have you smoked at all, even a puff, in the last 7 days?") and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1504 participants
Primary outcome timeframe
6 months post quit date
Results posted on
2011-11-30
Participant Flow
Participant milestones
| Measure |
Nicotine Patch
nicotine patch alone treatment for nicotine dependence.
|
Nicotine Lozenge
nicotine lozenge alone treatment
|
Nicotine Patch + Lozenge
nicotine patch + lozenge combination treatment
|
Bupropion
bupropion alone treatment
|
Bupropion + Nicotine Lozenge
bupropion + nicotine lozenge combination treatment
|
Placebo Control
placebo control (no active medication) treatment
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
262
|
260
|
267
|
264
|
262
|
189
|
|
Overall Study
COMPLETED
|
250
|
238
|
258
|
244
|
250
|
174
|
|
Overall Study
NOT COMPLETED
|
12
|
22
|
9
|
20
|
12
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms
Baseline characteristics by cohort
| Measure |
Nicotine Patch
n=262 Participants
nicotine patch alone treatment for nicotine dependence.
|
Nicotine Lozenge
n=260 Participants
nicotine lozenge alone treatment
|
Nicotine Patch + Lozenge
n=267 Participants
nicotine patch + lozenge combination treatment
|
Bupropion
n=264 Participants
bupropion alone treatment
|
Bupropion + Nicotine Lozenge
n=262 Participants
bupropion + nicotine lozenge combination treatment
|
Placebo Control
n=189 Participants
placebo control (no active medication) treatment
|
Total
n=1504 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
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
252 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
256 Participants
n=4 Participants
|
256 Participants
n=21 Participants
|
179 Participants
n=8 Participants
|
1461 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
|
Age Continuous
|
44.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
44.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
45.3 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
43.1 years
STANDARD_DEVIATION 11.4 • n=8 Participants
|
44.7 years
STANDARD_DEVIATION 11.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
154 Participants
n=21 Participants
|
111 Participants
n=8 Participants
|
876 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
78 Participants
n=8 Participants
|
628 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
262 participants
n=5 Participants
|
260 participants
n=7 Participants
|
267 participants
n=5 Participants
|
264 participants
n=4 Participants
|
262 participants
n=21 Participants
|
189 participants
n=8 Participants
|
1504 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 6 months post quit dateSmoking status was assessed both as 7-day point-prevalence abstinence ("Have you smoked at all, even a puff, in the last 7 days?") and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).
Outcome measures
| Measure |
Nicotine Patch
n=262 Participants
nicotine patch alone treatment for nicotine dependence.
|
Nicotine Lozenge
n=260 Participants
nicotine lozenge alone treatment
|
Nicotine Patch + Lozenge
n=267 Participants
nicotine patch + lozenge combination treatment
|
Bupropion
n=264 Participants
bupropion alone treatment
|
Bupropion + Nicotine Lozenge
n=262 Participants
bupropion + nicotine lozenge combination treatment
|
Placebo Control
n=189 Participants
placebo control (no active medication) treatment
|
|---|---|---|---|---|---|---|
|
7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed
|
90 participants with<10 ppm exhaled CO
|
87 participants with<10 ppm exhaled CO
|
107 participants with<10 ppm exhaled CO
|
84 participants with<10 ppm exhaled CO
|
87 participants with<10 ppm exhaled CO
|
42 participants with<10 ppm exhaled CO
|
Adverse Events
Nicotine Patch
Serious events: 5 serious events
Other events: 207 other events
Deaths: 0 deaths
Nicotine Lozenge
Serious events: 5 serious events
Other events: 214 other events
Deaths: 0 deaths
Nicotine Patch + Lozenge
Serious events: 5 serious events
Other events: 227 other events
Deaths: 0 deaths
Bupropion
Serious events: 8 serious events
Other events: 195 other events
Deaths: 0 deaths
Bupropion + Nicotine Lozenge
Serious events: 6 serious events
Other events: 217 other events
Deaths: 0 deaths
Placebo Control
Serious events: 6 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicotine Patch
n=262 participants at risk
nicotine patch alone treatment for nicotine dependence.
|
Nicotine Lozenge
n=260 participants at risk
nicotine lozenge alone treatment
|
Nicotine Patch + Lozenge
n=267 participants at risk
nicotine patch + lozenge combination treatment
|
Bupropion
n=264 participants at risk
bupropion alone treatment
|
Bupropion + Nicotine Lozenge
n=262 participants at risk
bupropion + nicotine lozenge combination treatment
|
Placebo Control
n=189 participants at risk
placebo control (no active medication) treatment
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
hospitalization: cardiovascular
|
0.38%
1/262 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
1.2%
3/260 • Number of events 3 • 6 months
collection of data at all visits and phone contacts
|
0.75%
2/267 • Number of events 2 • 6 months
collection of data at all visits and phone contacts
|
1.1%
3/264 • Number of events 3 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
1.1%
2/189 • Number of events 2 • 6 months
collection of data at all visits and phone contacts
|
|
Surgical and medical procedures
hospitalization: surgical
|
0.76%
2/262 • Number of events 2 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/260 • 6 months
collection of data at all visits and phone contacts
|
1.1%
3/267 • Number of events 3 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/264 • 6 months
collection of data at all visits and phone contacts
|
1.1%
3/262 • Number of events 3 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/189 • 6 months
collection of data at all visits and phone contacts
|
|
Respiratory, thoracic and mediastinal disorders
hospitalization: respiratory
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/260 • 6 months
collection of data at all visits and phone contacts
|
0.37%
1/267 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.38%
1/264 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
1.6%
3/189 • Number of events 3 • 6 months
collection of data at all visits and phone contacts
|
|
Gastrointestinal disorders
Hopitalization: abdominal pain
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/260 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/267 • 6 months
collection of data at all visits and phone contacts
|
0.38%
1/264 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/189 • 6 months
collection of data at all visits and phone contacts
|
|
Psychiatric disorders
Hospitalization: psychiatric and alcohol
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/260 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/267 • 6 months
collection of data at all visits and phone contacts
|
0.38%
1/264 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/189 • 6 months
collection of data at all visits and phone contacts
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/260 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/267 • 6 months
collection of data at all visits and phone contacts
|
0.38%
1/264 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.53%
1/189 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
|
General disorders
hospitalization: general
|
0.38%
1/262 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.77%
2/260 • Number of events 2 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/267 • 6 months
collection of data at all visits and phone contacts
|
0.38%
1/264 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.76%
2/262 • Number of events 2 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/189 • 6 months
collection of data at all visits and phone contacts
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.38%
1/262 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/260 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/267 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/264 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/189 • 6 months
collection of data at all visits and phone contacts
|
|
Respiratory, thoracic and mediastinal disorders
Death: COPD
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/260 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/267 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/264 • 6 months
collection of data at all visits and phone contacts
|
0.38%
1/262 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/189 • 6 months
collection of data at all visits and phone contacts
|
Other adverse events
| Measure |
Nicotine Patch
n=262 participants at risk
nicotine patch alone treatment for nicotine dependence.
|
Nicotine Lozenge
n=260 participants at risk
nicotine lozenge alone treatment
|
Nicotine Patch + Lozenge
n=267 participants at risk
nicotine patch + lozenge combination treatment
|
Bupropion
n=264 participants at risk
bupropion alone treatment
|
Bupropion + Nicotine Lozenge
n=262 participants at risk
bupropion + nicotine lozenge combination treatment
|
Placebo Control
n=189 participants at risk
placebo control (no active medication) treatment
|
|---|---|---|---|---|---|---|
|
Infections and infestations
cold
|
35.1%
92/262 • Number of events 92 • 6 months
collection of data at all visits and phone contacts
|
39.2%
102/260 • Number of events 102 • 6 months
collection of data at all visits and phone contacts
|
33.0%
88/267 • Number of events 88 • 6 months
collection of data at all visits and phone contacts
|
28.0%
74/264 • Number of events 74 • 6 months
collection of data at all visits and phone contacts
|
24.8%
65/262 • Number of events 65 • 6 months
collection of data at all visits and phone contacts
|
30.2%
57/189 • Number of events 57 • 6 months
collection of data at all visits and phone contacts
|
|
Infections and infestations
cough
|
6.1%
16/262 • Number of events 16 • 6 months
collection of data at all visits and phone contacts
|
5.0%
13/260 • Number of events 13 • 6 months
collection of data at all visits and phone contacts
|
4.9%
13/267 • Number of events 13 • 6 months
collection of data at all visits and phone contacts
|
3.4%
9/264 • Number of events 9 • 6 months
collection of data at all visits and phone contacts
|
3.1%
8/262 • Number of events 8 • 6 months
collection of data at all visits and phone contacts
|
3.7%
7/189 • Number of events 7 • 6 months
collection of data at all visits and phone contacts
|
|
General disorders
dizziness
|
2.7%
7/262 • Number of events 7 • 6 months
collection of data at all visits and phone contacts
|
1.9%
5/260 • Number of events 5 • 6 months
collection of data at all visits and phone contacts
|
3.4%
9/267 • Number of events 9 • 6 months
collection of data at all visits and phone contacts
|
2.3%
6/264 • Number of events 6 • 6 months
collection of data at all visits and phone contacts
|
5.7%
15/262 • Number of events 15 • 6 months
collection of data at all visits and phone contacts
|
3.2%
6/189 • Number of events 6 • 6 months
collection of data at all visits and phone contacts
|
|
General disorders
Dry mouth
|
0.38%
1/262 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/260 • 6 months
collection of data at all visits and phone contacts
|
0.75%
2/267 • Number of events 2 • 6 months
collection of data at all visits and phone contacts
|
7.6%
20/264 • Number of events 20 • 6 months
collection of data at all visits and phone contacts
|
9.5%
25/262 • Number of events 25 • 6 months
collection of data at all visits and phone contacts
|
1.6%
3/189 • Number of events 3 • 6 months
collection of data at all visits and phone contacts
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
3.8%
10/260 • Number of events 10 • 6 months
collection of data at all visits and phone contacts
|
3.4%
9/267 • Number of events 9 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/264 • 6 months
collection of data at all visits and phone contacts
|
6.1%
16/262 • Number of events 16 • 6 months
collection of data at all visits and phone contacts
|
2.1%
4/189 • Number of events 4 • 6 months
collection of data at all visits and phone contacts
|
|
Infections and infestations
flu
|
3.4%
9/262 • Number of events 9 • 6 months
collection of data at all visits and phone contacts
|
6.2%
16/260 • Number of events 16 • 6 months
collection of data at all visits and phone contacts
|
5.6%
15/267 • Number of events 15 • 6 months
collection of data at all visits and phone contacts
|
2.7%
7/264 • Number of events 7 • 6 months
collection of data at all visits and phone contacts
|
8.4%
22/262 • Number of events 22 • 6 months
collection of data at all visits and phone contacts
|
5.3%
10/189 • Number of events 10 • 6 months
collection of data at all visits and phone contacts
|
|
General disorders
headache
|
9.9%
26/262 • Number of events 26 • 6 months
collection of data at all visits and phone contacts
|
11.2%
29/260 • Number of events 29 • 6 months
collection of data at all visits and phone contacts
|
12.7%
34/267 • Number of events 34 • 6 months
collection of data at all visits and phone contacts
|
8.7%
23/264 • Number of events 23 • 6 months
collection of data at all visits and phone contacts
|
11.5%
30/262 • Number of events 30 • 6 months
collection of data at all visits and phone contacts
|
12.7%
24/189 • Number of events 24 • 6 months
collection of data at all visits and phone contacts
|
|
General disorders
hiccups
|
0.00%
0/262 • 6 months
collection of data at all visits and phone contacts
|
13.5%
35/260 • Number of events 35 • 6 months
collection of data at all visits and phone contacts
|
8.2%
22/267 • Number of events 22 • 6 months
collection of data at all visits and phone contacts
|
0.00%
0/264 • 6 months
collection of data at all visits and phone contacts
|
2.7%
7/262 • Number of events 7 • 6 months
collection of data at all visits and phone contacts
|
0.53%
1/189 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
|
Gastrointestinal disorders
heartburn
|
0.76%
2/262 • Number of events 2 • 6 months
collection of data at all visits and phone contacts
|
11.9%
31/260 • Number of events 31 • 6 months
collection of data at all visits and phone contacts
|
8.2%
22/267 • Number of events 22 • 6 months
collection of data at all visits and phone contacts
|
0.76%
2/264 • Number of events 2 • 6 months
collection of data at all visits and phone contacts
|
8.0%
21/262 • Number of events 21 • 6 months
collection of data at all visits and phone contacts
|
0.53%
1/189 • Number of events 1 • 6 months
collection of data at all visits and phone contacts
|
|
Infections and infestations
nausea
|
9.5%
25/262 • Number of events 25 • 6 months
collection of data at all visits and phone contacts
|
16.9%
44/260 • Number of events 44 • 6 months
collection of data at all visits and phone contacts
|
20.6%
55/267 • Number of events 55 • 6 months
collection of data at all visits and phone contacts
|
7.6%
20/264 • Number of events 20 • 6 months
collection of data at all visits and phone contacts
|
12.6%
33/262 • Number of events 33 • 6 months
collection of data at all visits and phone contacts
|
8.5%
16/189 • Number of events 16 • 6 months
collection of data at all visits and phone contacts
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
32.4%
85/262 • Number of events 85 • 6 months
collection of data at all visits and phone contacts
|
1.2%
3/260 • Number of events 3 • 6 months
collection of data at all visits and phone contacts
|
23.6%
63/267 • Number of events 63 • 6 months
collection of data at all visits and phone contacts
|
4.5%
12/264 • Number of events 12 • 6 months
collection of data at all visits and phone contacts
|
5.7%
15/262 • Number of events 15 • 6 months
collection of data at all visits and phone contacts
|
4.2%
8/189 • Number of events 8 • 6 months
collection of data at all visits and phone contacts
|
|
General disorders
sleep disturbance
|
25.6%
67/262 • Number of events 67 • 6 months
collection of data at all visits and phone contacts
|
6.9%
18/260 • Number of events 18 • 6 months
collection of data at all visits and phone contacts
|
23.6%
63/267 • Number of events 63 • 6 months
collection of data at all visits and phone contacts
|
33.3%
88/264 • Number of events 88 • 6 months
collection of data at all visits and phone contacts
|
26.3%
69/262 • Number of events 69 • 6 months
collection of data at all visits and phone contacts
|
10.6%
20/189 • Number of events 20 • 6 months
collection of data at all visits and phone contacts
|
|
General disorders
throat irritation
|
2.7%
7/262 • Number of events 7 • 6 months
collection of data at all visits and phone contacts
|
6.9%
18/260 • Number of events 18 • 6 months
collection of data at all visits and phone contacts
|
7.9%
21/267 • Number of events 21 • 6 months
collection of data at all visits and phone contacts
|
2.3%
6/264 • Number of events 6 • 6 months
collection of data at all visits and phone contacts
|
6.1%
16/262 • Number of events 16 • 6 months
collection of data at all visits and phone contacts
|
2.6%
5/189 • Number of events 5 • 6 months
collection of data at all visits and phone contacts
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place