Trial Outcomes & Findings for Efficacy of Varenicline in Ambivalent Smokers (NCT NCT00595868)
NCT ID: NCT00595868
Last Updated: 2011-12-02
Results Overview
A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.
COMPLETED
PHASE2
220 participants
6 months
2011-12-02
Participant Flow
Enrolled sample size of 220; 2 were excluded because found to be ineligible after enrollment
Participant milestones
| Measure |
Varenicline
2 milligrams varenicline once per day for 2-8 weeks
|
Placebo
Placebo once per day for 2-8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
111
|
|
Overall Study
COMPLETED
|
62
|
61
|
|
Overall Study
NOT COMPLETED
|
45
|
50
|
Reasons for withdrawal
| Measure |
Varenicline
2 milligrams varenicline once per day for 2-8 weeks
|
Placebo
Placebo once per day for 2-8 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
45
|
50
|
Baseline Characteristics
Efficacy of Varenicline in Ambivalent Smokers
Baseline characteristics by cohort
| Measure |
Varenicline
n=107 Participants
2 milligrams varenicline once per day for 2-8 weeks
|
Placebo
n=111 Participants
Placebo once per day for 2-8 weeks
|
Total
n=218 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
|
99 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age Continuous
|
44 years
STANDARD_DEVIATION 14 • n=5 Participants
|
41 years
STANDARD_DEVIATION 15 • n=7 Participants
|
42 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
42 participants
n=5 Participants
|
47 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
64 participants
n=5 Participants
|
63 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=5 Participants
|
111 participants
n=7 Participants
|
218 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsA quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.
Outcome measures
| Measure |
Varenicline
n=107 Participants
2 milligrams varenicline once per day for 2-8 weeks
|
Placebo
n=111 Participants
Placebo once per day for 2-8 weeks
|
|---|---|---|
|
Number of Participants With a Quit Attempt
|
55 participants
|
36 participants
|
SECONDARY outcome
Timeframe: 6 months7 day point prevalent abstinence 6 months after enrolling in the study was determined by two steps: (1) A report of no days of smoking for the 7 days prior to the 6 month on the Time Line Follow Back obtained at a telephone call 6 months after enrollment; (2) Those who reported no smoking for the prior 7 days came to our lab for breath carbon monoxide (CO) measurement to confirm abstinence. Breath CO had to be less than 10 parts per million for the participant to be classified as abstinent.
Outcome measures
| Measure |
Varenicline
n=107 Participants
2 milligrams varenicline once per day for 2-8 weeks
|
Placebo
n=111 Participants
Placebo once per day for 2-8 weeks
|
|---|---|---|
|
7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million
|
15 participants
|
8 participants
|
Adverse Events
Varenicline
Placebo
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