Trial Outcomes & Findings for Measuring Smoking Behaviors While Using Varenicline (NCT NCT00948155)

Results Overview

Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

Days 1-21 of each of 2 study periods

Results posted on

2014-12-16

Participant Flow

Recruitment occurred in a research laboratory in a school of medicine. Dates of recruitment: first participant first visit March 31, 2009; last participants last visit December 02, 2010

48 participants signed consents and were enrolled in the study. Medical clearance was achieved by 41; 29 returned for the first laboratory visit which is the first day drug/placebo was administered. The 12 who did not return for the Day 1 visit were not included further in the study. There was a minimum 14 washout period between drug conditions.

Participant milestones

Participant milestones
Measure	Placebo Then Varenicline Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.	Varenicline Before Placebo Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
First Intervention 21 Days STARTED	14	15
First Intervention 21 Days COMPLETED	12	13
First Intervention 21 Days NOT COMPLETED	2	2
Washout 14 Days STARTED	12	13
Washout 14 Days COMPLETED	11	11
Washout 14 Days NOT COMPLETED	1	2
Second Intervention 21 Days STARTED	11	11
Second Intervention 21 Days COMPLETED	9	8
Second Intervention 21 Days NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Then Varenicline Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.	Varenicline Before Placebo Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
First Intervention 21 Days Lost to Follow-up	2	2
Washout 14 Days Lost to Follow-up	1	2

Baseline Characteristics

Measuring Smoking Behaviors While Using Varenicline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then Varenicline n=14 Participants Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.	Varenicline Before Placebo n=15 Participants Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.	Total n=29 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	14 Participants n=5 Participants	15 Participants n=7 Participants	29 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 13.7 • n=5 Participants	37.6 years STANDARD_DEVIATION 12.8 • n=7 Participants	39.9 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1-21 of each of 2 study periods

Population: All those participants who completed both study periods were included in the analysis.

Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.

Outcome measures

Outcome measures
Measure	Placebo Then Varenicline n=9 Participants Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.	Varenicline Before Placebo n=8 Participants Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
Smoking Topography: Total Puff Volume	523.4 milliliters Standard Error 41	684.6 milliliters Standard Error 33

PRIMARY outcome

Timeframe: Days 1, 7, 21 of each of two 21 day study periods

Population: All participants who completed the task were included in the analysis

Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.

Outcome measures

Outcome measures
Measure	Placebo Then Varenicline n=9 Participants Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.	Varenicline Before Placebo n=8 Participants Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.	12 number of puffs chosen of a maximum 24 Standard Error 4.5	11.5 number of puffs chosen of a maximum 24 Standard Error 5.1

PRIMARY outcome

Timeframe: Two 21 day study periods

Average of the number of cigarettes smoked per day