Trial Outcomes & Findings for Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation (NCT NCT01622998)
NCT ID: NCT01622998
Last Updated: 2026-08-14
Results Overview
Self-reported continuous abstinence at week 52 post target quit date will be confirmed with a carbon monoxide breath test.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
303 participants
Primary outcome timeframe
Week 52
Results posted on
2026-08-14
Participant Flow
Participant milestones
| Measure |
Standard Transdermal NRT Group (UC)
10 week standard transdermal nicotine replacement therapy patch protocol
|
Titrated Transdermal NRT Group (EXP)
10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
152
|
|
Overall Study
COMPLETED
|
129
|
130
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
Reasons for withdrawal
| Measure |
Standard Transdermal NRT Group (UC)
10 week standard transdermal nicotine replacement therapy patch protocol
|
Titrated Transdermal NRT Group (EXP)
10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
22
|
Baseline Characteristics
149 participants in each group were included in the analysis due to lost to follow up.
Baseline characteristics by cohort
| Measure |
Standard Transdermal NRT Group (UC)
n=149 Participants
10 week standard transdermal nicotine replacement therapy patch protocol
|
Titrated Transdermal NRT Group (EXP)
n=149 Participants
10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable.
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.4 Years
STANDARD_DEVIATION 10.9 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
49.02 Years
STANDARD_DEVIATION 11.6 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
48.2 Years
STANDARD_DEVIATION 11.3 • n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Sex: Female, Male
Female
|
57 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
52 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
109 Participants
n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Sex: Female, Male
Male
|
92 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
97 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
189 Participants
n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Formal Education
|
14.2 Years of formal education
STANDARD_DEVIATION 2.6 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
14.2 Years of formal education
STANDARD_DEVIATION 2.8 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
14.2 Years of formal education
STANDARD_DEVIATION 2.7 • n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Baseline BMI
|
28.0 Kg/m^2
STANDARD_DEVIATION 5.7 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
28.8 Kg/m^2
STANDARD_DEVIATION 5.6 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
28.4 Kg/m^2
STANDARD_DEVIATION 5.7 • n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Household Income
<$20,000 per year
|
23 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
29 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
52 Participants
n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Household Income
$20,000 to $59,999
|
50 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
47 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
97 Participants
n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Household Income
>$60,000
|
61 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
60 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
121 Participants
n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Household Income
Unknown (missing or prefer not to say)
|
15 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
13 Participants
n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
28 Participants
n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Fagerstrom Test for Nicotine Dependence (FTCD) Score
|
6.1 Scores on a scale
STANDARD_DEVIATION 2.1 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
5.8 Scores on a scale
STANDARD_DEVIATION 2.2 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
6.0 Scores on a scale
STANDARD_DEVIATION 2.1 • n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Duration of Smoking
|
29.0 Years
STANDARD_DEVIATION 11.7 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
30.1 Years
STANDARD_DEVIATION 12.3 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
29.5 Years
STANDARD_DEVIATION 12.0 • n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Cigarettes smoked per day in the past month
|
23.3 cigarettes per day
STANDARD_DEVIATION 7.6 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
24.1 cigarettes per day
STANDARD_DEVIATION 9.6 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
23.7 cigarettes per day
STANDARD_DEVIATION 8.6 • n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
|
Number of quit attempts in the past year
|
5.0 quit attempts
STANDARD_DEVIATION 9.1 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
4.3 quit attempts
STANDARD_DEVIATION 5.6 • n=149 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
4.7 quit attempts
STANDARD_DEVIATION 7.5 • n=298 Participants • 149 participants in each group were included in the analysis due to lost to follow up.
|
PRIMARY outcome
Timeframe: Week 52Self-reported continuous abstinence at week 52 post target quit date will be confirmed with a carbon monoxide breath test.
Outcome measures
| Measure |
Standard Transdermal NRT Group (UC)
n=149 Participants
10 week standard transdermal nicotine replacement therapy patch protocol
|
Titrated Transdermal NRT Group (EXP)
n=149 Participants
10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable.
|
|---|---|---|
|
Validated Continuous Abstinence Rate at Week 52
|
17 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: weeks 10, 26Self-reported continuous abstinence rates will be validated with a carbon monoxide breath test at weeks 10 and 26 post target quit date.
Outcome measures
| Measure |
Standard Transdermal NRT Group (UC)
n=149 Participants
10 week standard transdermal nicotine replacement therapy patch protocol
|
Titrated Transdermal NRT Group (EXP)
n=149 Participants
10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable.
|
|---|---|---|
|
Validated Continuous Abstinence Rates at Weeks 10 and 26 Weeks
at 10 weeks
|
68 Participants
|
78 Participants
|
|
Validated Continuous Abstinence Rates at Weeks 10 and 26 Weeks
26 weeks
|
27 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Self-reported seven day point prevalence of abstinence will be validated at week 10, 26 and 52 weeks post target quite date.Outcome measures
| Measure |
Standard Transdermal NRT Group (UC)
n=149 Participants
10 week standard transdermal nicotine replacement therapy patch protocol
|
Titrated Transdermal NRT Group (EXP)
n=149 Participants
10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable.
|
|---|---|---|
|
Self Reported 7-day Point Prevalence at Weeks 10, 26 and 52.
at 10 weeks
|
52 Participants
|
66 Participants
|
|
Self Reported 7-day Point Prevalence at Weeks 10, 26 and 52.
at 26 weeks
|
37 Participants
|
45 Participants
|
|
Self Reported 7-day Point Prevalence at Weeks 10, 26 and 52.
at 52 weeks
|
31 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Week 1 to 52Outcome measures
| Measure |
Standard Transdermal NRT Group (UC)
n=149 Participants
10 week standard transdermal nicotine replacement therapy patch protocol
|
Titrated Transdermal NRT Group (EXP)
n=149 Participants
10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable.
|
|---|---|---|
|
Self-reported Continuous Abstinence at Weeks 10, 26 and 52
at week 52
|
18 Participants
|
32 Participants
|
|
Self-reported Continuous Abstinence at Weeks 10, 26 and 52
at week 10
|
57 Participants
|
51 Participants
|
|
Self-reported Continuous Abstinence at Weeks 10, 26 and 52
at week 26
|
31 Participants
|
39 Participants
|
Adverse Events
Standard Transdermal NRT Group (UC)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Titrated Transdermal NRT Group (EXP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Transdermal NRT Group (UC)
n=149 participants at risk
10 week standard transdermal nicotine replacement therapy patch protocol
|
Titrated Transdermal NRT Group (EXP)
n=149 participants at risk
10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable.
|
|---|---|---|
|
Cardiac disorders
Increased heart rate
|
0.67%
1/149 • Baseline to 52 weeks
|
0.00%
0/149 • Baseline to 52 weeks
|
|
General disorders
Allergic reaction to patch adhesive
|
0.67%
1/149 • Baseline to 52 weeks
|
0.00%
0/149 • Baseline to 52 weeks
|
Additional Information
Dr. Robert Reid
University of Ottawa Heart Institute
Phone: 6136967000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place