Trial Outcomes & Findings for Cigarette Smoking Among Young Adults (NCT NCT04340947)

NCT ID: NCT04340947

Last Updated: 2025-08-22

Results Overview

total inhalation volume from smoking behavior in the laboratory

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 171 participants
• Primary outcome timeframe: Baseline to week 4
• Results posted on: 2025-08-22

Participant Flow

N= 171 were eligible and enrolled at the first visit. N=143 people attended Visit 2 to smoke their usual brand (UB) cigarette, and n=139 were randomized to the intervention. After visit 2, the intervention began where people smoked a menthol and non-menthol VLNC (order counterbalanced) in two subsequent visits (VLNC 1 visit, VLNC 2 visit). There was a 7-day washout period between VLNC 1 and VLNC 2 smoking. The experimental tobacco marketplace was the final visit.

This is a within-subjects design. Participants were assigned to both smoke menthol and non-menthol very low nicotine cigarettes in visits 3 and 4 and at home for a week prior to each visit. The order of administration of menthol vs non-menthol flavor was counterbalanced to reduce the impact of order effects. The number of people to start a period may not equal the number who completed the previous period due to loss to follow-up.

Participant milestones

Measure	Menthol Very Low Nicotine Cigarette First Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette First Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Usual Brand Smoking (Visit 2) STARTED	69	70
Usual Brand Smoking (Visit 2) COMPLETED	69	70
Usual Brand Smoking (Visit 2) NOT COMPLETED	0	0
VLNC 1 Smoking (Visit 3) STARTED	56	60
VLNC 1 Smoking (Visit 3) COMPLETED	56	60
VLNC 1 Smoking (Visit 3) NOT COMPLETED	0	0
7-day Washout Period STARTED	56	60
7-day Washout Period COMPLETED	51	56
7-day Washout Period NOT COMPLETED	5	4
VLNC 2 Smoking (Visit 4) STARTED	51	56
VLNC 2 Smoking (Visit 4) COMPLETED	51	56
VLNC 2 Smoking (Visit 4) NOT COMPLETED	0	0
Experimental Tobacco Marketplace (Visit) STARTED	49	54
Experimental Tobacco Marketplace (Visit) COMPLETED	49	54
Experimental Tobacco Marketplace (Visit) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Menthol Very Low Nicotine Cigarette First Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette First Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
7-day Washout Period Lost to Follow-up	5	4

Baseline Characteristics

Data on sex missing for 1 person.

Baseline characteristics by cohort

Measure	All Study Participants n=171 Participants Participants will smoke menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one menthol flavored very low nicotine cigarette in the laboratory. Very low nicotine cigarettes: Participants were randomized to smoke menthol and non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory.
Age, Continuous	25.16 years STANDARD_DEVIATION 4.41 • n=171 Participants
Sex: Female, Male Female	84 Participants n=171 Participants • Data on sex missing for 1 person.
Sex: Female, Male Male	87 Participants n=171 Participants • Data on sex missing for 1 person.
Race/Ethnicity, Customized Non-hispanic Black	22 Participants n=171 Participants
Race/Ethnicity, Customized Non-hispanic white	102 Participants n=171 Participants
Race/Ethnicity, Customized Non-hispanic other race	25 Participants n=171 Participants
Race/Ethnicity, Customized Hispanic	22 Participants n=171 Participants
Region of Enrollment United States	171 participants n=171 Participants
Cigarettes/day	8.86 unit of measure "cigarettes per day" STANDARD_DEVIATION 6.58 • n=171 Participants
Time-to-first cigarette Smoke within 5 minutes of waking	36 Participants n=170 Participants • Data missing for n=1
Time-to-first cigarette Smoke within 6 or more minutes after waking	134 Participants n=170 Participants • Data missing for n=1

PRIMARY outcome

Timeframe: Baseline to week 4

Population: Analysis was restricted to individuals who completed at 2 study visits (of 3 visits). Some individuals were excluded from analysis because of missing smoking data that was not captured by the smoking topography device or several participants who erroneously smoked more than 1 cigarette.

total inhalation volume from smoking behavior in the laboratory

Outcome measures

Measure	Usual Brand Cigarette n=111 Participants After baseline, participants are instructed to smoke their usual brand as they would for 7 days and then return to the laboratory and smoke 1 of their usual brand cigarettes in the lab. Participants are then randomly assigned, through counterbalancing, to smoke a menthol very low nicotine and a non-menthol very low nicotine cigarette (order counterbalanced) in the following visits 3 and 4.	Menthol Very Low Nicotine Cigarette n=99 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette n=103 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Puff Topography	1108 mL Standard Deviation 1013.7	1045.2 mL Standard Deviation 1119.4	1084.6 mL Standard Deviation 1141

PRIMARY outcome

Timeframe: Baseline to week 9

Population: Population included participants who completed at two study visits and who did not have any missing data on the outcomes

Subjective response to smoking, as measured by self-reported psychological reward (scale) of the modified Cigarette Evaluation Scale, administered after smoking. The minimum value is 1 and the maximum value is 7; with 7 indicating greater psychological reward.

Outcome measures

Measure	Usual Brand Cigarette n=111 Participants After baseline, participants are instructed to smoke their usual brand as they would for 7 days and then return to the laboratory and smoke 1 of their usual brand cigarettes in the lab. Participants are then randomly assigned, through counterbalancing, to smoke a menthol very low nicotine and a non-menthol very low nicotine cigarette (order counterbalanced) in the following visits 3 and 4.	Menthol Very Low Nicotine Cigarette n=111 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette n=111 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Ratings of Psychological Reward	3.1 score on a scale Standard Deviation 1.30	2.9 score on a scale Standard Deviation 1.40	2.3 score on a scale Standard Deviation 1.30

PRIMARY outcome

Timeframe: Assessed during tobacco purchase tasks completed at week 5

Population: We report raw data on number of non-menthol VLNCs purchased at each price.

Purchasing of non-menthol very low nicotine cigarettes in the Experimental Tobacco Marketplace (ETM) task 1 and 2. Product units purchased per cigarette price displayed in the ETM, displayed as milligrams of nicotine. Prices are $0.12, $0.25, $0.5, $1, $2, $4, $8, and $16 per cigarette. Data are presented as units purchased on a log scale, per recommended best practices.

Outcome measures

Measure	Usual Brand Cigarette n=103 Participants After baseline, participants are instructed to smoke their usual brand as they would for 7 days and then return to the laboratory and smoke 1 of their usual brand cigarettes in the lab. Participants are then randomly assigned, through counterbalancing, to smoke a menthol very low nicotine and a non-menthol very low nicotine cigarette (order counterbalanced) in the following visits 3 and 4.	Menthol Very Low Nicotine Cigarette n=103 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) $0.12	20.40 log (mg of nicotine) Standard Deviation 36.22	6.11 log (mg of nicotine) Standard Deviation 18.38	—
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) $0.25	14.44 log (mg of nicotine) Standard Deviation 26.64	3.66 log (mg of nicotine) Standard Deviation 13.11	—
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) $0.50	10.17 log (mg of nicotine) Standard Deviation 19.25	3.37 log (mg of nicotine) Standard Deviation 12.21	—
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) $1.00	5.68 log (mg of nicotine) Standard Deviation 14.64	1.68 log (mg of nicotine) Standard Deviation 7.21	—
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) $2.00	2.56 log (mg of nicotine) Standard Deviation 7.56	1.18 log (mg of nicotine) Standard Deviation 6.33	—
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) $4.00	1.16 log (mg of nicotine) Standard Deviation 6.04	0.34 log (mg of nicotine) Standard Deviation 1.69	—
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) $8.00	0.44 log (mg of nicotine) Standard Deviation 2.13	0.06 log (mg of nicotine) Standard Deviation 0.43	—
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) $16.00	0.25 log (mg of nicotine) Standard Deviation 1.51	0.02 log (mg of nicotine) Standard Deviation 0.13	—

SECONDARY outcome

Timeframe: Baseline to week 4

Population: Population included individuals who completed at least 2 study visits and who did not have any missing data.

measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm)

Outcome measures

Measure	Usual Brand Cigarette n=92 Participants After baseline, participants are instructed to smoke their usual brand as they would for 7 days and then return to the laboratory and smoke 1 of their usual brand cigarettes in the lab. Participants are then randomly assigned, through counterbalancing, to smoke a menthol very low nicotine and a non-menthol very low nicotine cigarette (order counterbalanced) in the following visits 3 and 4.	Menthol Very Low Nicotine Cigarette n=92 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette n=92 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Exhaled CO Boost Before smoking	4.08 parts per million (ppm) Standard Deviation 5.03	3.72 parts per million (ppm) Standard Deviation 4.16	3.9 parts per million (ppm) Standard Deviation 5.12
Exhaled CO Boost After smoking	9.17 parts per million (ppm) Standard Deviation 9.42	7.65 parts per million (ppm) Standard Deviation 6.84	6.79 parts per million (ppm) Standard Deviation 6.80

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 9

Population: Population included individuals who completed at least 2 study visits and who did not have any missing data.

Symptoms of nicotine withdrawal were measured using the Minnesota Nicotine Withdrawal Scale. Response options range from 0=none to 4=severe; where higher scores indicate more severe nicotine withdrawal.

Outcome measures

Measure	Usual Brand Cigarette n=92 Participants After baseline, participants are instructed to smoke their usual brand as they would for 7 days and then return to the laboratory and smoke 1 of their usual brand cigarettes in the lab. Participants are then randomly assigned, through counterbalancing, to smoke a menthol very low nicotine and a non-menthol very low nicotine cigarette (order counterbalanced) in the following visits 3 and 4.	Menthol Very Low Nicotine Cigarette n=92 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette n=92 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Nicotine Withdrawal Before smoking	0.54 score on a scale Standard Deviation 0.47	0.48 score on a scale Standard Deviation .41	0.47 score on a scale Standard Deviation 0.45
Nicotine Withdrawal After smoking	.26 score on a scale Standard Deviation .29	.27 score on a scale Standard Deviation .30	.30 score on a scale Standard Deviation .29

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 9

Population: Population included individuals who completed at least 2 study visits and who did not have any missing data.

1-item craving measure from the Minnesota Nicotine Withdrawal Scale. Response options range from 0 (none/not at all) to 4 (severe), where 4 indicates higher craving for a cigarette.

Outcome measures

Measure	Usual Brand Cigarette n=92 Participants After baseline, participants are instructed to smoke their usual brand as they would for 7 days and then return to the laboratory and smoke 1 of their usual brand cigarettes in the lab. Participants are then randomly assigned, through counterbalancing, to smoke a menthol very low nicotine and a non-menthol very low nicotine cigarette (order counterbalanced) in the following visits 3 and 4.	Menthol Very Low Nicotine Cigarette n=92 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette n=92 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Change in Cigarette Craving Before and After Smoking	2.18 score on a scale Standard Deviation 1.38	1.92 score on a scale Standard Deviation 1.43	1.85 score on a scale Standard Deviation 1.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 8

Population: Population includes individuals who attended the visit and who completed the questionnaire on perceived health risks of the cigarette flavor they smoked in the previous week.

This scale measures perceptions of risk from smoking one's usual brand or the very low nicotine cigarettes. Participants completed this questionnaire at the beginning of each in-person smoking visit (after a week of smoking the assigned cigarette at home). The measure has 7 questions. Each question has response options ranging from 1 (very low risk of disease) to 10 (very high risk of disease). Higher scores indicate greater perceived risk. The outcome reflects the total score, divided by 7 (the number of questions)

Outcome measures

Measure	Usual Brand Cigarette n=135 Participants After baseline, participants are instructed to smoke their usual brand as they would for 7 days and then return to the laboratory and smoke 1 of their usual brand cigarettes in the lab. Participants are then randomly assigned, through counterbalancing, to smoke a menthol very low nicotine and a non-menthol very low nicotine cigarette (order counterbalanced) in the following visits 3 and 4.	Menthol Very Low Nicotine Cigarette n=111 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette n=107 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Perceived Health Risk Scale	5.30 units on a scale Standard Deviation 2.2	4.45 units on a scale Standard Deviation 2.28	4.45 units on a scale Standard Deviation 2.18

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 4

Population: Population included individuals who completed at least 2 study visits and who did not have any missing data.

Heart rate is measured as beats per minute (BPM); where higher scores indicate higher heart rate.

Outcome measures

Measure	Usual Brand Cigarette n=92 Participants After baseline, participants are instructed to smoke their usual brand as they would for 7 days and then return to the laboratory and smoke 1 of their usual brand cigarettes in the lab. Participants are then randomly assigned, through counterbalancing, to smoke a menthol very low nicotine and a non-menthol very low nicotine cigarette (order counterbalanced) in the following visits 3 and 4.	Menthol Very Low Nicotine Cigarette n=92 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.	Non-menthol Very Low Nicotine Cigarette n=92 Participants Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced.
Heart Rate Before smoking	76.85 beats per minute Standard Deviation 12.38	75.03 beats per minute Standard Deviation 13.62	77.25 beats per minute Standard Deviation 12.77
Heart Rate After smoking	85.73 beats per minute Standard Deviation 14.06	75.72 beats per minute Standard Deviation 14.38	76.42 beats per minute Standard Deviation 13.00

Adverse Events

All Participants

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	All Participants n=171 participants at risk All participants enrolled in the study, n=171
Respiratory, thoracic and mediastinal disorders Respiratory symptoms	0.58% 1/171 • Number of events 1 • 4 months The definition does not differ. Adverse events were collected via a self-report form at the beginning of each in person visit.

Additional Information

Professor of Pediatrics

University of Oklahoma Health Sciences

Phone: 405-271-1903

Email: heal-lab@ouhsc.edu

Results disclosure agreements

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