Trial Outcomes & Findings for Long-term Varenicline Treatment for Smoking Cessation (NCT NCT00828113)
NCT ID: NCT00828113
Last Updated: 2015-11-20
Results Overview
Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
7-day point prevalence
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
Extended Treatment
52-week varenicline therapy + individual smoking cessation counseling
|
Standard Treatment
13 weeks of varenicline therapy + individual smoking cessation counseling
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
30
|
31
|
Reasons for withdrawal
| Measure |
Extended Treatment
52-week varenicline therapy + individual smoking cessation counseling
|
Standard Treatment
13 weeks of varenicline therapy + individual smoking cessation counseling
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
27
|
26
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
Baseline Characteristics
Long-term Varenicline Treatment for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Extended Treatment
n=50 Participants
52-week varenicline therapy + individual smoking cessation counseling
|
Standard Treatment
n=51 Participants
13 weeks of varenicline therapy + individual smoking cessation counseling
|
Total
n=101 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
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 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
|
42.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
101 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-day point prevalencePopulation: Participants randomized at 12 weeks who continued in the study to Week 52 and provided CO-verified smoking status.
Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52
Outcome measures
| Measure |
Extended Treatment
n=33 Participants
52-week varenicline therapy + individual smoking cessation counseling
|
Standard Treatment
n=34 Participants
13 weeks of varenicline therapy + individual smoking cessation counseling
|
|---|---|---|
|
Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52
|
10 participants
|
11 participants
|
Adverse Events
Extended Treatment
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Standard Treatment
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extended Treatment
n=33 participants at risk
52-week varenicline therapy + individual smoking cessation counseling
|
Standard Treatment
n=34 participants at risk
13 weeks of varenicline therapy + individual smoking cessation counseling
|
|---|---|---|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.00%
0/33
Number of participants at risk based upon those available to be randomized at Week 12
|
2.9%
1/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
Renal and urinary disorders
Bladder Surgery
|
3.0%
1/33
Number of participants at risk based upon those available to be randomized at Week 12
|
0.00%
0/34
Number of participants at risk based upon those available to be randomized at Week 12
|
Other adverse events
| Measure |
Extended Treatment
n=33 participants at risk
52-week varenicline therapy + individual smoking cessation counseling
|
Standard Treatment
n=34 participants at risk
13 weeks of varenicline therapy + individual smoking cessation counseling
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33
Number of participants at risk based upon those available to be randomized at Week 12
|
0.00%
0/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
General disorders
General Disorders NOS
|
3.0%
1/33
Number of participants at risk based upon those available to be randomized at Week 12
|
8.8%
3/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Disorder
|
18.2%
6/33
Number of participants at risk based upon those available to be randomized at Week 12
|
8.8%
3/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory NOS
|
0.00%
0/33
Number of participants at risk based upon those available to be randomized at Week 12
|
8.8%
3/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
Metabolism and nutrition disorders
Metabolism NOS
|
6.1%
2/33
Number of participants at risk based upon those available to be randomized at Week 12
|
0.00%
0/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
Infections and infestations
Infection NOS
|
9.1%
3/33
Number of participants at risk based upon those available to be randomized at Week 12
|
5.9%
2/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal NOS
|
9.1%
3/33
Number of participants at risk based upon those available to be randomized at Week 12
|
11.8%
4/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
Vascular disorders
Hypertension
|
6.1%
2/33
Number of participants at risk based upon those available to be randomized at Week 12
|
11.8%
4/34
Number of participants at risk based upon those available to be randomized at Week 12
|
|
Injury, poisoning and procedural complications
Injuries
|
9.1%
3/33
Number of participants at risk based upon those available to be randomized at Week 12
|
2.9%
1/34
Number of participants at risk based upon those available to be randomized at Week 12
|
Additional Information
Douglas E. Jorenby, Ph.D.
University of Wisconsin School of Medicine and Public Health
Phone: 6082627527
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60