Trial Outcomes & Findings for Human Laboratory Study Of Varenicline in Smokers (NCT NCT00709696)
NCT ID: NCT00709696
Last Updated: 2017-12-27
Results Overview
Scale is equal to days subject did not smoke Scale is 0-5 0 being no days 5 being did not quit at all
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
21 days
Results posted on
2017-12-27
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo Varenicline
Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
|
Varenicline
Varenicline
Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human Laboratory Study Of Varenicline in Smokers
Baseline characteristics by cohort
| Measure |
Placebo Varenicline
n=4 Participants
Placebo Varenicline
Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
|
Varenicline
n=3 Participants
Varenicline
Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
|
Total
n=7 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
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 5.69 • n=93 Participants
|
38.3 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
32.0 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Treatment-seeking smokers
Scale is equal to days subject did not smoke Scale is 0-5 0 being no days 5 being did not quit at all
Outcome measures
| Measure |
Placebo Varenicline
n=4 Participants
Placebo Varenicline
Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
|
Varenicline
n=3 Participants
Varenicline
Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
|
|---|---|---|
|
Nicotine Withdrawal Scale
|
3.3 units on a scale
Standard Deviation 5.3
|
0.3 units on a scale
Standard Deviation 3.8
|
Adverse Events
Placebo Varenicline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Varenicline
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