Trial Outcomes & Findings for Effectiveness of Varenicline: Testing Individual Differences (NCT NCT01228175)

NCT ID: NCT01228175

Last Updated: 2018-05-09

Results Overview

The number of cigarettes smoked were assessed only on a "smoking day", i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 218 participants
• Primary outcome timeframe: up to 36 weeks
• Results posted on: 2018-05-09

Participant Flow

Participant milestones

Measure	Varenicline Varenicline Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily	Microcrystal Cellulose Microcrystal cellulose placebo Placebo: 25mg look alike riboflavin tablets to match active study medication.
Overall Study STARTED	119	99
Overall Study COMPLETED	53	46
Overall Study NOT COMPLETED	66	53

Reasons for withdrawal

Measure	Varenicline Varenicline Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily	Microcrystal Cellulose Microcrystal cellulose placebo Placebo: 25mg look alike riboflavin tablets to match active study medication.
Overall Study Lost to Follow-up	64	50
Overall Study Withdrawal by Subject	1	2
Overall Study Physician Decision	1	1

Baseline Characteristics

Effectiveness of Varenicline: Testing Individual Differences

Baseline characteristics by cohort

Measure	Varenicline n=119 Participants Varenicline Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily	Microcrystal Cellulose n=99 Participants Microcrystal cellulose placebo Placebo: 25mg look alike riboflavin tablets to match active study medication.	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	119 Participants n=5 Participants	99 Participants n=7 Participants	218 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	64 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Region of Enrollment United States	119 Participants n=5 Participants	99 Participants n=7 Participants	218 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 36 weeks

The number of cigarettes smoked were assessed only on a "smoking day", i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks.

Outcome measures

Measure	Varenicline n=53 Participants Varenicline Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily	Microcrystal Cellulose n=46 Participants Microcrystal cellulose placebo Placebo: 25mg look alike riboflavin tablets to match active study medication.
Cigarettes Per Smoking Day	4.9256 Cigarettes per smoking day Standard Deviation 5.62357	8.4989 Cigarettes per smoking day Standard Deviation 8.53172

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Microcrystal Cellulose

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

Dr. Kent Hutchison

University of Colorado Boulder

Phone: 303-492-8163

Email: kent.hutchison@colorado.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place