Trial Outcomes & Findings for Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation (NCT NCT00364156)
NCT ID: NCT00364156
Last Updated: 2018-02-28
Results Overview
To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
568 participants
Primary outcome timeframe
End of Treatment (week 24)
Results posted on
2018-02-28
Participant Flow
Participants were recruited using mass media advertising from the the Greater Philadelphia area from June 2004 to April 2008.
Once participants were enrolled and were eligible at the medical screening visit they were randomized to receiving either 8 weeks of 21 mg nicotine patch or 6 months of 21 mg nicotine patch treatment
Participant milestones
| Measure |
Extended Patch Treatment
Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
|
Standard Patch Treatment
Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
|
|---|---|---|
|
Overall Study
STARTED
|
282
|
286
|
|
Overall Study
COMPLETED
|
203
|
205
|
|
Overall Study
NOT COMPLETED
|
79
|
81
|
Reasons for withdrawal
| Measure |
Extended Patch Treatment
Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
|
Standard Patch Treatment
Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
73
|
80
|
|
Overall Study
Protocol Violation
|
6
|
1
|
Baseline Characteristics
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Extended Patch Treatment
n=282 Participants
Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
|
Standard Patch Treatment
n=286 Participants
Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
|
Total
n=568 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
281 Participants
n=93 Participants
|
286 Participants
n=4 Participants
|
567 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
44.9 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
44.8 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=93 Participants
|
129 Participants
n=4 Participants
|
254 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=93 Participants
|
157 Participants
n=4 Participants
|
314 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
282 participants
n=93 Participants
|
286 participants
n=4 Participants
|
568 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (week 24)Population: Intention to Treat analysis (ITT)
To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.
Outcome measures
| Measure |
Extended Patch Treatment
n=282 Participants
Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
|
Standard Patch Treatment
n=286 Participants
Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
|
|---|---|---|
|
Biochemically Verified 7-day Point Prevalence Abstinence
|
89 Participants
|
58 Participants
|
Adverse Events
Extended Patch Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Standard Patch Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extended Patch Treatment
n=282 participants at risk
Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
|
Standard Patch Treatment
n=286 participants at risk
Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/282 • 4 years
|
0.35%
1/286 • Number of events 1 • 4 years
|
Other adverse events
| Measure |
Extended Patch Treatment
n=282 participants at risk
Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
|
Standard Patch Treatment
n=286 participants at risk
Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
|
|---|---|---|
|
Psychiatric disorders
Agressive Thoughts
|
0.35%
1/282 • Number of events 1 • 4 years
|
0.00%
0/286 • 4 years
|
|
Nervous system disorders
Seizure during Blood Draw
|
0.35%
1/282 • Number of events 1 • 4 years
|
0.00%
0/286 • 4 years
|
|
Cardiac disorders
Hypertension
|
0.71%
2/282 • Number of events 2 • 4 years
|
0.00%
0/286 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place