Trial Outcomes & Findings for Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products (NCT NCT06093659)

NCT ID: NCT06093659

Last Updated: 2025-02-03

Results Overview

Maximum measured plasma nicotine concentration, following the controlled product use session

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use

Results posted on

2025-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Product Use Sequence ABECD Subjects use Product A on Day 1, Product B on Day 2, Product E on Day 3 and Product C on Day 4 and Product D on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Product Use Sequence BCADE Subjects use Product B on Day 1, Product C on Day 2, Product A on Day 3 and Product D on Day 4 and Product E on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Product Use Sequence CDBEA Subjects use Product C on Day 1, Product D on Day 2, Product B on Day 3 and Product E on Day 4 and Product A on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Product Use Sequence DECAB Subjects use Product D on Day 1, Product E on Day 2, Product C on Day 3 and Product A on Day 4 and Product B on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Product Use Sequence EADBC Subjects use Product E on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 and Product C on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).
Overall Study STARTED	5	5	5	5	5
Overall Study COMPLETED	5	5	5	5	5
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Product Use Sequence ABECD n=5 Participants Subjects use Product A on Day 1, Product B on Day 2, Product E on Day 3 and Product C on Day 4 and Product D on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Product Use Sequence BCADE n=5 Participants Subjects use Product B on Day 1, Product C on Day 2, Product A on Day 3 and Product D on Day 4 and Product E on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Product Use Sequence CDBEA n=5 Participants Subjects use Product C on Day 1, Product D on Day 2, Product B on Day 3 and Product E on Day 4 and Product A on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Product Use Sequence DECAB n=5 Participants Subjects use Product D on Day 1, Product E on Day 2, Product C on Day 3 and Product A on Day 4 and Product B on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Product Use Sequence EADBC n=5 Participants Subjects use Product E on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 and Product C on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals).	Total n=25 Participants Total of all reporting groups
Age, Continuous	46.4 years STANDARD_DEVIATION 9.91 • n=5 Participants	39.4 years STANDARD_DEVIATION 8.62 • n=7 Participants	43.2 years STANDARD_DEVIATION 8.70 • n=5 Participants	36.4 years STANDARD_DEVIATION 12.58 • n=4 Participants	37.8 years STANDARD_DEVIATION 6.06 • n=21 Participants	40.6 years STANDARD_DEVIATION 9.38 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	10 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	15 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	25 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	25 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Body Mass Index (BMI)	25.46 kg/m^2 STANDARD_DEVIATION 3.11 • n=5 Participants	25.43 kg/m^2 STANDARD_DEVIATION 1.57 • n=7 Participants	25.63 kg/m^2 STANDARD_DEVIATION 3.85 • n=5 Participants	22.80 kg/m^2 STANDARD_DEVIATION 2.72 • n=4 Participants	26.15 kg/m^2 STANDARD_DEVIATION 3.34 • n=21 Participants	25.10 kg/m^2 STANDARD_DEVIATION 3.00 • n=8 Participants

PRIMARY outcome

Timeframe: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use

Maximum measured plasma nicotine concentration, following the controlled product use session

Outcome measures

Outcome measures
Measure	Product A n=25 Participants All subjects after having used Product A under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product B n=25 Participants All subjects after having used Product B under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product C n=25 Participants All subjects after having used Product C under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product D n=25 Participants All subjects after having used Product D under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product E n=25 Participants All subjects after having used Product E under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Nicotine Cmax	13.00 ng/mL Standard Deviation 9.80	12.97 ng/mL Standard Deviation 7.10	6.00 ng/mL Standard Deviation 3.28	6.87 ng/mL Standard Deviation 3.24	18.51 ng/mL Standard Deviation 10.05

PRIMARY outcome

Timeframe: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use

The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, following the controlled product use session

Outcome measures

Outcome measures
Measure	Product A n=25 Participants All subjects after having used Product A under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product B n=25 Participants All subjects after having used Product B under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product C n=25 Participants All subjects after having used Product C under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product D n=25 Participants All subjects after having used Product D under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product E n=25 Participants All subjects after having used Product E under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Nicotine AUCt	716.3 ng*min/mL Standard Deviation 329.6	777.0 ng*min/mL Standard Deviation 289.4	363.9 ng*min/mL Standard Deviation 123.8	382.5 ng*min/mL Standard Deviation 145.0	1144.0 ng*min/mL Standard Deviation 427.9

SECONDARY outcome

Timeframe: 10 minutes prior to the start of the product use session

The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'.

Outcome measures

Outcome measures
Measure	Product A n=25 Participants All subjects after having used Product A under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product B n=25 Participants All subjects after having used Product B under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product C n=25 Participants All subjects after having used Product C under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product D n=25 Participants All subjects after having used Product D under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product E n=25 Participants All subjects after having used Product E under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Urge to Smoke Pre-use	93.6 units on a scale Standard Deviation 10.7	94.0 units on a scale Standard Deviation 8.2	92.9 units on a scale Standard Deviation 8.8	91.9 units on a scale Standard Deviation 13.0	90.0 units on a scale Standard Deviation 17.8

SECONDARY outcome

Timeframe: At 240 minutes following the start of study product use

Outcome measures

Outcome measures
Measure	Product A n=25 Participants All subjects after having used Product A under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product B n=25 Participants All subjects after having used Product B under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product C n=25 Participants All subjects after having used Product C under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product D n=25 Participants All subjects after having used Product D under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product E n=25 Participants All subjects after having used Product E under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Urge to Smoke Post-use	91.4 units on a scale Standard Deviation 13.3	90.7 units on a scale Standard Deviation 11.9	88.7 units on a scale Standard Deviation 15.5	88.3 units on a scale Standard Deviation 18.6	87.6 units on a scale Standard Deviation 18.2

SECONDARY outcome

Timeframe: 10 minutes prior to the start of the product use session and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use.

The subjects self-assess their urge to smoke at defined time points by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'A great deal'. Emax is calculated as the maximum absolute value of change from baseline (pre-use) (i.e., the maximum response) in VAS scores.

Outcome measures

Outcome measures
Measure	Product A n=25 Participants All subjects after having used Product A under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product B n=25 Participants All subjects after having used Product B under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product C n=25 Participants All subjects after having used Product C under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product D n=25 Participants All subjects after having used Product D under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)	Product E n=25 Participants All subjects after having used Product E under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Urge to Smoke Emax	56.0 units on a scale Standard Deviation 29.0	64.4 units on a scale Standard Deviation 29.0	43.0 units on a scale Standard Deviation 31.7	44.3 units on a scale Standard Deviation 28.9	69.2 units on a scale Standard Deviation 28.4

SECONDARY outcome

Timeframe: Hours 2-4 of the 4-hour ad libitum product use session

Population: Topography parameters were only available for subsets of subjects due to technical issues with the puff topography analyser during the data recording process, which resulted in incomplete data capture for some participants.

Number of puffs taken during last 2 hours of the 4-hour ad-libitum product use session