Trial Outcomes & Findings for Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II (NCT NCT00734617)
NCT ID: NCT00734617
Last Updated: 2014-07-15
Results Overview
Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.
COMPLETED
PHASE3
479 participants
May 2009
2014-07-15
Participant Flow
Recruitment start date: 8/20/2007 Recruitment end date: 3/19/2008 Recruitment locations: Duke Center for Nicotine \& Smoking Cessation Research offices located in Charlotte, Durham, Raleigh and Winston-Salem NC.
Participants were excluded for the following reasons: DID NOT MEET INCLUSION CRITERIA: 78 MET EXCLUSION CRITERIA: 74 UNABLE TO MEET STUDY REQUIREMENTS: 9 REFUSED TO PARTICIPATE: 18 LOST TO CONTACT (PRIOR TO V1): 30 LAB RESULTS: 64 MD/PA REFUSAL: 179 30 DAYS PAST PHYSICAL SCREENING: 1
Participant milestones
| Measure |
Less Dependent
|
More Dependent
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
230
|
|
Overall Study
COMPLETED
|
142
|
128
|
|
Overall Study
NOT COMPLETED
|
107
|
102
|
Reasons for withdrawal
| Measure |
Less Dependent
|
More Dependent
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
103
|
95
|
Baseline Characteristics
Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
Baseline characteristics by cohort
| Measure |
Less Dependent
n=249 Participants
|
More Dependent
n=230 Participants
|
Total
n=479 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
|
|
Age, Categorical
Between 18 and 65 years
|
249 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
479 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
44.34 years
STANDARD_DEVIATION 10.92 • n=7 Participants
|
43.53 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
249 participants
n=5 Participants
|
230 participants
n=7 Participants
|
479 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: May 2009Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.
Outcome measures
| Measure |
Less Dependent
n=249 Participants
|
More Dependent
n=230 Participants
|
|---|---|---|
|
Continuous Abstinence From Smoking at Ten Weeks Post-quit
21mg Nicotine Patch
|
31 participants
|
21 participants
|
|
Continuous Abstinence From Smoking at Ten Weeks Post-quit
42mg Nicotine Patch
|
17 participants
|
26 participants
|
Adverse Events
Less Dependent
More Dependent
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jed E. Rose, Ph.D.
Duke Center for Nicotine & Smoking Cessation Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place