Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior

• Sponsor: Yale University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04009850
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), Food and Drug Administration (FDA) (U.S. Fed)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Months): 31
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use	Other: Cigarette Brand Switching; Other: E-cigarette Flavor	N/A

Detailed Description

The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettesWithin-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Nov 9, 2019
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Menthol e-cigarette Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette	Other: Cigarette Brand Switching; Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
Experimental: Tobacco e-cigarette Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette	Other: E-cigarette Flavor; Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes

Outcome Measures

Primary Outcome Measures

1. Total Number of Cigarettes Smoked [Week 6]

   Self-reported total number of cigarettes smoked per day (Timeline Follow Back)

Secondary Outcome Measures

1. E-cigarette Use [Week 6]

   Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)

2. Tobacco Product Satisfaction [Week 6]

   Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction

3. Motivation to Quit Smoking [Week 6]

   Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit

4. Nicotine Dependence [Week 6]

   Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 or older

• Able to read English

• Cigarette smoker

Exclusion Criteria:

• Seeking smoking cessation treatment

• Serious psychiatric or medical condition

• Use of other drugs

• Unable or unwilling to complete study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)
• Food and Drug Administration (FDA)

Investigators

• Principal Investigator: Krysten Bold, Ph.D., Yale University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 16, 2019

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04009850
• Other Study ID Numbers: 2000025572; 2U54DA036151-06
• First Posted: Jul 5, 2019
• Last Update Posted: May 17, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Menthol E-cigarette	Tobacco E-cigarette
Arm/Group Description	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
Period Title: Overall Study
STARTED	3	0
COMPLETED	3	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Menthol E-cigarette	Tobacco E-cigarette	Total
Arm/Group Description	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes	Total of all reporting groups
Overall Participants	3	0	3
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	3 100%	0 NaN	3 100%
>=65 years	0 0%	0 NaN	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.3 (13.6)	43.3 (13.6)
Sex: Female, Male (Count of Participants)
Female	1 33.3%	1 Infinity
Male	2 66.7%	2 Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 NaN
Not Hispanic or Latino	3 100%	3 Infinity
Unknown or Not Reported	0 0%	0 NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN
Asian	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN
Black or African American	1 33.3%	1 Infinity
White	2 66.7%	2 Infinity
More than one race	0 0%	0 NaN
Unknown or Not Reported	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	3 100%	3 Infinity

Outcome Measures

1. Primary Outcome

Title	Total Number of Cigarettes Smoked
Description	Self-reported total number of cigarettes smoked per day (Timeline Follow Back)
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

No participants were enrolled in the tobacco e-cigarette condition.

Arm/Group Title	Menthol E-cigarette	Tobacco E-cigarette
Arm/Group Description	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
Measure Participants	3	0
Mean (Standard Deviation) [cigarettes per day]	19 (16)

2. Secondary Outcome

Title	E-cigarette Use
Description	Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Analyses were not conducted for this outcome examining use by e-cigarette flavor condition because no participants were enrolled in the tobacco e-cigarette condition.

Arm/Group Title	Menthol E-cigarette	Tobacco E-cigarette
Arm/Group Description	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
Measure Participants	0	0

3. Secondary Outcome

Title	Tobacco Product Satisfaction
Description	Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

No participants were enrolled in the tobacco e-cigarette condition.

Arm/Group Title	Menthol E-cigarette	Tobacco E-cigarette
Arm/Group Description	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
Measure Participants	3	0
Mean (Standard Deviation) [units on a scale]	1.7 (1.6)

4. Secondary Outcome

Title	Motivation to Quit Smoking
Description	Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

No participants were enrolled in the tobacco e-cigarette condition.

Arm/Group Title	Menthol E-cigarette	Tobacco E-cigarette
Arm/Group Description	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
Measure Participants	3	0
Mean (Standard Deviation) [units on a scale]	7.7 (2.1)

5. Secondary Outcome

Title	Nicotine Dependence
Description	Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

No participants were enrolled in the tobacco e-cigarette condition.

Arm/Group Title	Menthol E-cigarette	Tobacco E-cigarette
Arm/Group Description	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
Measure Participants	3	0
Mean (Standard Deviation) [score on a scale]	3.8 (1.1)

Adverse Events

Time Frame	Adverse event data were collected for the 10 weeks of study participation.
Adverse Event Reporting Description	No participants were enrolled in the tobacco e-cigarette condition.
Arm/Group Title	Menthol E-cigarette		Tobacco E-cigarette
Arm/Group Description	Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes		Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
All Cause Mortality
	Menthol E-cigarette		Tobacco E-cigarette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)
Serious Adverse Events
	Menthol E-cigarette		Tobacco E-cigarette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Menthol E-cigarette		Tobacco E-cigarette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.