Trial Outcomes & Findings for Palatability of Experimental Cigarettes - Study 2 (NCT NCT01568905)

Last Updated: 2019-11-01

Results Overview

Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Second Visit (Week 1) minus Baseline (Day 1)

Results posted on

2019-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Low Level Nicotine Cigarette Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Arm 2 Intermediate Nicotine Level Cigarette Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	Arm 3 High Level Nicotine Cigarette High level nicotine cigarette: smoke the study cigarette exclusively for one week
Overall Study STARTED	13	11	12
Overall Study COMPLETED	12	11	12
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Palatability of Experimental Cigarettes - Study 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 Low Level Nicotine Cigarette n=12 Participants Low level nicotine cigarette (0.400 mg/g; menthol 0.405 mg/g): smoke the study cigarette exclusively for one week	Arm 2 Intermediate Nicotine Level Cigarette n=11 Participants Intermediate nicotine level cigarette (5.86 mg/g menthol 5.87 mg/g): smoke the study cigarette exclusively for one week	Arm 3 High Level Nicotine Cigarette n=12 Participants High level nicotine cigarette (10.4 mg/g; menthol: 12.3): smoke the study cigarette exclusively for one week	Total n=35 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	35 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	37.0 years STANDARD_DEVIATION 12.4 • n=5 Participants	32.7 years STANDARD_DEVIATION 10.8 • n=7 Participants	43.6 years STANDARD_DEVIATION 9.6 • n=5 Participants	37.9 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	11 participants n=7 Participants	12 participants n=5 Participants	35 participants n=4 Participants
Menthol Menthol	4 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	11 participants n=4 Participants
Menthol Non Menthol	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants
Cigarettes per day	16.8 Cigarettes per day STANDARD_DEVIATION 5.1 • n=5 Participants	16.1 Cigarettes per day STANDARD_DEVIATION 3.5 • n=7 Participants	18.7 Cigarettes per day STANDARD_DEVIATION 4.3 • n=5 Participants	17.2 Cigarettes per day STANDARD_DEVIATION 4.4 • n=4 Participants

PRIMARY outcome

Timeframe: Second Visit (Week 1) minus Baseline (Day 1)

Outcome measures

Outcome measures
Measure	Arm 1 Low Level Nicotine Cigarette n=12 Participants Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Arm 2 Intermediate Nicotine Level Cigarette n=11 Participants Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	Arm 3 High Level Nicotine Cigarette n=12 Participants High level nicotine cigarette: smoke the study cigarette exclusively for one week
Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1	-16.2 nmols/ml Standard Error 5.0	-7.6 nmols/ml Standard Error 4.7	1.3 nmols/ml Standard Error 4.4

SECONDARY outcome

Timeframe: Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)

Modified Cigarette Evaluation Scale \[CES\] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.

Outcome measures

Outcome measures
Measure	Arm 1 Low Level Nicotine Cigarette n=12 Participants Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Arm 2 Intermediate Nicotine Level Cigarette n=11 Participants Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	Arm 3 High Level Nicotine Cigarette n=12 Participants High level nicotine cigarette: smoke the study cigarette exclusively for one week
Responses on Modified Cigarette Evaluation Scale	36.8 units on a scale Standard Error 4.1	54.1 units on a scale Standard Error 4.1	61.4 units on a scale Standard Error 4.1

SECONDARY outcome

Timeframe: Baseline (Day 1) Compared to Second Visit (Week 1)

Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.

Outcome measures

Outcome measures
Measure	Arm 1 Low Level Nicotine Cigarette n=12 Participants Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Arm 2 Intermediate Nicotine Level Cigarette n=11 Participants Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	Arm 3 High Level Nicotine Cigarette n=12 Participants High level nicotine cigarette: smoke the study cigarette exclusively for one week
Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes	56.6 units on a scale Standard Error 4.6	66.7 units on a scale Standard Error 4.6	68.3 units on a scale Standard Error 4.6

SECONDARY outcome

Timeframe: 1 week

Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.

Outcome measures

Outcome measures
Measure	Arm 1 Low Level Nicotine Cigarette n=12 Participants Low level nicotine cigarette: smoke the study cigarette exclusively for one week	Arm 2 Intermediate Nicotine Level Cigarette n=11 Participants Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week	Arm 3 High Level Nicotine Cigarette n=12 Participants High level nicotine cigarette: smoke the study cigarette exclusively for one week
Comparison of Number of Cigarettes Smoked	92.1 cigarettes per week Standard Deviation 15.9	112.8 cigarettes per week Standard Deviation 49.4	157.6 cigarettes per week Standard Deviation 15.2

Adverse Events

Arm 1 Low Level Nicotine Cigarette

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 Intermediate Nicotine Level Cigarette

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3 High Level Nicotine Cigarette

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

Dorohty Hatsukami, Ph.D.

University of Minnesota Tobacco Research Programs

Phone: 612-626-2121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place