Trial Outcomes & Findings for Pre to Postoperative Smoking Cessation (NCT NCT02683161)
NCT ID: NCT02683161
Last Updated: 2018-07-17
Results Overview
Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Assessed starting in week 2 of 12 weekly study visits
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
Open-label Trial
Open label trial of varenicline, administered as clinically indicated, for smoking cessation in patients prior to and after surgery.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre to Postoperative Smoking Cessation
Baseline characteristics by cohort
| Measure |
Open-label Trial
n=5 Participants
Open label trial of varenicline, administered as clinically indicated, for smoking cessation in patients prior to and after surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed starting in week 2 of 12 weekly study visitsSmoking abstinence is defined the change in number of self-reported cigarettes smoked per week
Outcome measures
| Measure |
Open-label Group
n=5 Participants
Participants received clinically-indicated dose of varenicline for smoking cessation.
|
|---|---|
|
Change in Smoking Status
Week 2
|
7.4 Mean cigarettes per/day
Standard Deviation 4.1
|
|
Change in Smoking Status
Week 3
|
5.9 Mean cigarettes per/day
Standard Deviation 2.3
|
|
Change in Smoking Status
Week 4
|
6.0 Mean cigarettes per/day
Standard Deviation 2.1
|
|
Change in Smoking Status
Week 5
|
4.9 Mean cigarettes per/day
Standard Deviation 1.3
|
|
Change in Smoking Status
Week 6
|
0.8 Mean cigarettes per/day
Standard Deviation 0.7
|
|
Change in Smoking Status
Week 7
|
0 Mean cigarettes per/day
Standard Deviation 0
|
|
Change in Smoking Status
Week 8
|
0 Mean cigarettes per/day
Standard Deviation 0
|
|
Change in Smoking Status
Week 9
|
0 Mean cigarettes per/day
Standard Deviation 0
|
|
Change in Smoking Status
Week 11
|
0 Mean cigarettes per/day
Standard Deviation 0
|
|
Change in Smoking Status
Week 12
|
0 Mean cigarettes per/day
Standard Deviation 0
|
|
Change in Smoking Status
Week 10
|
0.3 Mean cigarettes per/day
Standard Deviation 0.6
|
Adverse Events
Open-label Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place