Trial Outcomes & Findings for Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers (NCT NCT05023096)
NCT ID: NCT05023096
Last Updated: 2026-04-22
Results Overview
Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Randomization and Week 6
Results posted on
2026-04-22
Participant Flow
Participant milestones
| Measure |
Menthol+Tobacco
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Tobacco
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Unflavored
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
24
|
|
Overall Study
COMPLETED
|
21
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers
Baseline characteristics by cohort
| Measure |
Menthol+Tobacco
n=24 Participants
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Tobacco
n=23 Participants
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Unflavored
n=24 Participants
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
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Age, Continuous
|
44.0 years
STANDARD_DEVIATION 13.6 • n=60 Participants
|
44.6 years
STANDARD_DEVIATION 10.6 • n=56 Participants
|
48.0 years
STANDARD_DEVIATION 10.6 • n=116 Participants
|
45.5 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=60 Participants
|
10 Participants
n=56 Participants
|
10 Participants
n=116 Participants
|
32 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=60 Participants
|
13 Participants
n=56 Participants
|
14 Participants
n=116 Participants
|
39 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=60 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=60 Participants
|
21 Participants
n=56 Participants
|
24 Participants
n=116 Participants
|
68 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=60 Participants
|
22 Participants
n=56 Participants
|
22 Participants
n=116 Participants
|
68 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
2 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=60 Participants
|
23 participants
n=56 Participants
|
24 participants
n=116 Participants
|
71 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Randomization and Week 6Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Outcome measures
| Measure |
Menthol+Tobacco
n=24 Participants
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Tobacco
n=23 Participants
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Unflavored
n=24 Participants
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
|---|---|---|---|
|
Average Daily Cigarette Use
Randomization (Week 0)
|
10.3 number of cigarettes per day
Standard Deviation 5.8
|
17.3 number of cigarettes per day
Standard Deviation 14.1
|
12.3 number of cigarettes per day
Standard Deviation 8.0
|
|
Average Daily Cigarette Use
Week 6
|
5.3 number of cigarettes per day
Standard Deviation 4.5
|
5.9 number of cigarettes per day
Standard Deviation 6.5
|
5.6 number of cigarettes per day
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: Randomization and Week 6A biomarker of combusted cigarette use collected from exhaled breath.
Outcome measures
| Measure |
Menthol+Tobacco
n=24 Participants
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Tobacco
n=23 Participants
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Unflavored
n=24 Participants
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
|---|---|---|---|
|
Carbon Monoxide Exposure
Randomization (Week 0)
|
19.5 ppm
Standard Deviation 9.6
|
25.5 ppm
Standard Deviation 14.8
|
21.5 ppm
Standard Deviation 19.0
|
|
Carbon Monoxide Exposure
Week 6
|
17.7 ppm
Standard Deviation 13.6
|
25.0 ppm
Standard Deviation 17.6
|
20.4 ppm
Standard Deviation 14.9
|
PRIMARY outcome
Timeframe: Week 6CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios involving their own brand cigarettes and condition-specific ENDS. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a their conditions-specific ENDS they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each ENDS puff cost $0.10. The outcome of the task is the willingness to pay in USD for each ENDS puff.
Outcome measures
| Measure |
Menthol+Tobacco
n=21 Participants
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Tobacco
n=21 Participants
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Unflavored
n=23 Participants
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
|---|---|---|---|
|
Willingness to Substitute From Cigarettes to ENDS
|
.41 % change in dollars
Standard Deviation .027
|
-.054 % change in dollars
Standard Deviation .028
|
-.055 % change in dollars
Standard Deviation .026
|
Adverse Events
Menthol+Tobacco
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Tobacco
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Unflavored
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menthol+Tobacco
n=24 participants at risk
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Tobacco
n=23 participants at risk
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Unflavored
n=24 participants at risk
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Hallucinations
|
4.2%
1/24 • Number of events 1 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
0.00%
0/23 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
0.00%
0/24 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
4.2%
1/24 • Number of events 1 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
0.00%
0/23 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
0.00%
0/24 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
Other adverse events
| Measure |
Menthol+Tobacco
n=24 participants at risk
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Tobacco
n=23 participants at risk
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
Unflavored
n=24 participants at risk
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Tobacco product administration and assessment: Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
16.7%
4/24 • Number of events 4 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
21.7%
5/23 • Number of events 5 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
41.7%
10/24 • Number of events 10 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Vital capacity abnormal
|
83.3%
20/24 • Number of events 20 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
91.3%
21/23 • Number of events 21 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
70.8%
17/24 • Number of events 17 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Forced expiratory volume
|
70.8%
17/24 • Number of events 17 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
69.6%
16/23 • Number of events 16 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
79.2%
19/24 • Number of events 19 • From Screening/Enrollment to Follow-up (~2.5 months)
Study personnel may learn of the occurrence of an AE in a variety of ways: AE Trigger Questions collected at each visit; the participant self-reports reports the AE at a scheduled study visit; AE triggered by study-related biomeasures (blood pressure or pulmonary function test critical value observed) and/or unscheduled reporting.
|
Additional Information
Caroline Cobb, Associate Professor
Virginia Commonwealth University
Phone: 804-828-1867
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place