Trial Outcomes & Findings for Perceptions of Cigarette Smoking in Young Adults (NCT NCT03953508)

NCT ID: NCT03953508

Last Updated: 2024-12-16

Results Overview

ratings of subjective satisfaction from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. The minimum score is 1and the maximum score is 7.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 199 participants
• Primary outcome timeframe: immediately after smoking usual brand cigarette, at baseline
• Results posted on: 2024-12-16

Participant Flow

The order in which phases occurred differed as a result of COVID-19 restrictions on in-person data collection. Some participants started EMA first and then began laboratory data collection when in-person data collection was allowed. Other participants started laboratory data collection first (when COVID restrictions were lifted), and then did EMA after laboratory data collection. Thus, the participant flow may appear unbalanced.

Participant milestones

Measure	Menthol Status Those who prefer menthol cigarettes	Non-menthol Status Those who prefer non-menthol
Baseline STARTED	95	104
Baseline COMPLETED	92	102
Baseline NOT COMPLETED	3	2
Ecological Momentary Assessment STARTED	65	74
Ecological Momentary Assessment COMPLETED	63	62
Ecological Momentary Assessment NOT COMPLETED	2	12
Laboratory Period STARTED	59	59
Laboratory Period COMPLETED	54	54
Laboratory Period NOT COMPLETED	5	5
6-month Follow-up STARTED	92	102
6-month Follow-up COMPLETED	30	32
6-month Follow-up NOT COMPLETED	62	70

Reasons for withdrawal

Measure	Menthol Status Those who prefer menthol cigarettes	Non-menthol Status Those who prefer non-menthol
Baseline Lost to Follow-up	3	2
6-month Follow-up Lost to Follow-up	62	70

Baseline Characteristics

Perceptions of Cigarette Smoking in Young Adults

Baseline characteristics by cohort

Measure	Menthol Status n=60 Participants Those who prefer menthol cigarettes	Non-menthol Status n=61 Participants Those who prefer non-menthol	Total n=121 Participants Total of all reporting groups
Age, Continuous	23.6 years STANDARD_DEVIATION 2.2 • n=5 Participants	24.2 years STANDARD_DEVIATION 2.0 • n=7 Participants	23.9 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Race/Ethnicity, Customized White	37 Participants n=5 Participants	39 Participants n=7 Participants	76 Participants n=5 Participants
Race/Ethnicity, Customized Non-White	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment United States	60 Participants n=5 Participants	61 Participants n=7 Participants	121 Participants n=5 Participants
Highest level of education High school education or less	24 Participants n=5 Participants	35 Participants n=7 Participants	59 Participants n=5 Participants
Highest level of education Some college education or more	36 Participants n=5 Participants	26 Participants n=7 Participants	62 Participants n=5 Participants
Cigarettes smoked per day	8.1 cigarettes smoked per day STANDARD_DEVIATION 5.4 • n=5 Participants	11.8 cigarettes smoked per day STANDARD_DEVIATION 7.4 • n=7 Participants	10 cigarettes smoked per day STANDARD_DEVIATION 6.7 • n=5 Participants
Past 30-day cigarette smoking frequency	24.0 Number of days smoked cigarettes STANDARD_DEVIATION 8.7 • n=5 Participants	26.5 Number of days smoked cigarettes STANDARD_DEVIATION 7.9 • n=7 Participants	25.2 Number of days smoked cigarettes STANDARD_DEVIATION 8.4 • n=5 Participants

PRIMARY outcome

Timeframe: immediately after smoking usual brand cigarette, at baseline

Population: Young adult menthol and non-menthol smokers, ages 18-26 who completed the baseline/first study visit

ratings of subjective satisfaction from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. The minimum score is 1and the maximum score is 7.

Outcome measures

Measure	Menthol n=60 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=61 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale	4.68 score on a scale Standard Error 0.16	4.50 score on a scale Standard Error 0.16

PRIMARY outcome

Timeframe: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)

Population: Young adult menthol and non-menthol smokers who reported on their daily cigarette smoking during 14-days of ecological momentary assessment

average daily scores of subjective reward from smoking from daily diary surveys, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. Averaged across 14 days.

Outcome measures

Measure	Menthol n=62 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=62 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Average Daily Subjective Response From Smoking	1.68 average daily scores Standard Deviation 0.98	1.79 average daily scores Standard Deviation 0.86

PRIMARY outcome

Timeframe: Lab session 3 (estimated average 1-4 weeks after baseline)

Population: young adult cigarette smokers ages 18-26 who completed the third of three laboratory sessions

Participants completed a choice task assessing willingness to "work" to click targets on a computer screen to earn menthol or non-menthol cigarette puffs. The relative reinforcing value for menthol was defined by the Breakpoint, or the highest trial (out of 10 trials) completed for a menthol cigarette puff.

Outcome measures

Measure	Menthol n=54 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=53 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)	9.2 highest trial competed for menthol puffs Standard Deviation 2.05	0.83 highest trial competed for menthol puffs Standard Deviation 2.47

PRIMARY outcome

Timeframe: 6-month follow-up survey (6-months post-baseline)

Population: Young adult smokers ages 18-26 who completed the 6-month follow-up survey

Number of days smoked cigarettes in the past 30-days

Outcome measures

Measure	Menthol n=24 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=31 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Past 30-day Cigarette Smoking Frequency	20.8 days Standard Deviation 11.9	20.7 days Standard Deviation 11.4

PRIMARY outcome

Timeframe: Laboratory session 1 (up to 4 weeks after baseline)

Population: young adult cigarette smokers ages 18-26 who completed the baseline/visit 1 and provided valid puff topography data

Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1.

Outcome measures

Measure	Menthol n=60 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=61 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Puff Topography	18.7 number of cigarette puffs Standard Deviation 6.1	18.4 number of cigarette puffs Standard Deviation 7.3

SECONDARY outcome

Timeframe: immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline)

Population: Young adult cigarette smokers (ages 18-26) who completed session 3

This outcome represents the total number of clicks (over 10 trials) for the menthol cigarette puff on the behavioral choice task. The reinforcement schedule to click/earn a menthol cigarette puff increased progressively by 25 clicks at each trial such that 25, 50, 75, 100, 125, 150, 175, 200, 225, and 250 clicks of the menthol cigarette image on a computer screen had to be achieved to earn a menthol puff at each trial (maximum possible of 1375 clicks over the task for menthol puffs). All puffs were taken once the entire task was completed (after all 10 trials were done).

Outcome measures

Measure	Menthol n=54 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=53 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task	1244.56 number of clicks for menthol puffs Standard Deviation 326.49	104.11 number of clicks for menthol puffs Standard Deviation 334.44

SECONDARY outcome

Timeframe: 6-month follow-up (6-months post-baseline)

Population: Young adult smokers ages 18-26

Number of tobacco products used in the past 30-days

Outcome measures

Measure	Menthol n=24 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=31 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Quantity of Past 30-day Tobacco Product Use	1.3 tobacco products Standard Deviation 1	2 tobacco products Standard Deviation 0.9

SECONDARY outcome

Timeframe: 6-month follow-up (6-months post-baseline)

Population: Young adult cigarette smokers ages 18-26

Number of participants who self-reported intentions to smoke menthol cigarettes assessed via a questionnaire

Outcome measures

Measure	Menthol n=20 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Number of Participants With Intentions to Smoke Menthol Cigarettes	16 Participants	—

SECONDARY outcome

Timeframe: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)

Daily report of numbers of cigarettes smoked per day, over 14 days

Outcome measures

Measure	Menthol n=62 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=62 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Cigarettes Per Day	9.9 cigarettes per day Standard Deviation 7.6	9.5 cigarettes per day Standard Deviation 7.6

SECONDARY outcome

Timeframe: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)

Average daily cigarette craving, aggregated over 14 days, from a 1-item questionnaire measure that was administered daily. Scores range from 0 = not at all to 4 = extremely, where higher scores indicate greater craving intensity.

Outcome measures

Measure	Menthol n=62 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.	Non-menthol n=62 Participants Participants will smoke and rate puffs of their preferred brand/flavor cigarette.
Average Daily Craving From Smoking	1.55 average daily scores Standard Deviation 0.75	1.53 average daily scores Standard Deviation 0.75

Adverse Events

Menthol Status

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-menthol Status

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Menthol Status n=60 participants at risk Those who prefer menthol cigarettes	Non-menthol Status n=61 participants at risk Those who prefer non-menthol
Gastrointestinal disorders Other	0.00% 0/60 • Adverse events data were collected for the entirety of study participation; approximately 6 months. One participant vomited after smoking a cigarette in the study lab, after smoking a non-menthol Camel Crush cigarette. The participant was instructed to smoke 3 to 5 puffs In a subsequent follow-up (approximately a week later), the participant was feeling fine and wanted to schedule their next session. The participant indicated that they thought they had food poisoning. The adverse event was reported to the IRB and was not considered due to enrollment in the study or the study procedures.	1.6% 1/61 • Number of events 1 • Adverse events data were collected for the entirety of study participation; approximately 6 months. One participant vomited after smoking a cigarette in the study lab, after smoking a non-menthol Camel Crush cigarette. The participant was instructed to smoke 3 to 5 puffs In a subsequent follow-up (approximately a week later), the participant was feeling fine and wanted to schedule their next session. The participant indicated that they thought they had food poisoning. The adverse event was reported to the IRB and was not considered due to enrollment in the study or the study procedures.

Additional Information

Amy Cohn, PhD

University of Oklahoma Health Sciences Center

Phone: 4052711903

Email: amy-cohn@ouhsc.edu

Results disclosure agreements

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