Trial Outcomes & Findings for JUUL vs. Mod E-cigarette Study (NCT NCT04237272)

Last Updated: 2022-12-21

Results Overview

The percentage of choices to smoke the conventional cigarette at the Week 3 visit. Participants chose between smoking a conventional cigarette, using their assigned e-cigarette, and not using any tobacco product. Participants made the choice 10 times. Outcome is calculated as = ((number of choices to smoke / 10)\*100)

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Week 3 visit

Results posted on

2022-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Pod System Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period. Pod System E-cig: Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.	Customizable Tank Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week sampling period. Customizable Tank E-cig: Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week	Control Participants assigned to this arm will not receive any e-cigarette Control: Participants will not receive any e-cigarette
Overall Study STARTED	13	12	6
Overall Study COMPLETED	13	10	3
Overall Study NOT COMPLETED	0	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

JUUL vs. Mod E-cigarette Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pod System n=13 Participants Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period. Pod System E-cig: Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.	Customizable Tank n=12 Participants Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week sampling period. Customizable Tank E-cig: Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week	Control n=6 Participants Participants assigned to this arm will not receive any e-cigarette Control: Participants will not receive any e-cigarette	Total n=31 Participants Total of all reporting groups
Age, Continuous	41.23 Years STANDARD_DEVIATION 12.85 • n=5 Participants	46.25 Years STANDARD_DEVIATION 7.56 • n=7 Participants	52 Years STANDARD_DEVIATION 9.59 • n=5 Participants	45.26 Years STANDARD_DEVIATION 10.90 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	6 participants n=5 Participants	31 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 3 visit

Population: 2 participants in the customizable tank group are missing for this outcome. 1 was lost to follow up after baseline. 1 was unable to finish the Week 3 visit (missing some outcomes for this visit, but not all).

Outcome measures

Outcome measures
Measure	Pod System n=13 Participants Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period. Pod System E-cig: Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.	Customizable Tank n=10 Participants Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week sampling period. Customizable Tank E-cig: Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week	Control n=6 Participants Participants assigned to this arm will not receive any e-cigarette Control: Participants will not receive any e-cigarette
Choices to Smoke	26.15 Percentage of Total Choices Standard Deviation 27.85	30 Percentage of Total Choices Standard Deviation 31.27	38.33 Percentage of Total Choices Standard Deviation 29.27

SECONDARY outcome

Timeframe: Week 3

Population: 1 person was lost to follow up after baseline in the customizable tank group.

Average number of cigarettes smoked per day during Week 3 of sampling

Outcome measures

Outcome measures
Measure	Pod System n=13 Participants Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period. Pod System E-cig: Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.	Customizable Tank n=11 Participants Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week sampling period. Customizable Tank E-cig: Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week	Control n=6 Participants Participants assigned to this arm will not receive any e-cigarette Control: Participants will not receive any e-cigarette
Average Cigarettes Per Day	10.33 Cigarettes per Day Standard Deviation 7.72	9.90 Cigarettes per Day Standard Deviation 7.52	13.99 Cigarettes per Day Standard Deviation 6.67

Adverse Events

Pod System

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Customizable Tank

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pod System n=13 participants at risk Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period. Pod System E-cig: Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.	Customizable Tank n=12 participants at risk Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week sampling period. Customizable Tank E-cig: Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week	Control n=6 participants at risk Participants assigned to this arm will not receive any e-cigarette Control: Participants will not receive any e-cigarette
Respiratory, thoracic and mediastinal disorders Burning in the Throat	7.7% 1/13 • Number of events 1 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	33.3% 4/12 • Number of events 4 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	0.00% 0/6 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	8.3% 1/12 • Number of events 1 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	0.00% 0/6 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	25.0% 3/12 • Number of events 3 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	16.7% 1/6 • Number of events 1 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.
Respiratory, thoracic and mediastinal disorders Increased Phlegm	0.00% 0/13 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	33.3% 4/12 • Number of events 4 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	0.00% 0/6 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.
Gastrointestinal disorders Stomachache	0.00% 0/13 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	8.3% 1/12 • Number of events 1 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	16.7% 1/6 • Number of events 1 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.
Respiratory, thoracic and mediastinal disorders Throat and Mouth Irritation	7.7% 1/13 • Number of events 1 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	0.00% 0/12 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	0.00% 0/6 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.
General disorders Headache	0.00% 0/13 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	8.3% 1/12 • Number of events 1 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.	0.00% 0/6 • 3 Weeks Questionnaire at each visit asking about risks listed in the consent form as well as soliciting other adverse events that were not specifically named.

Additional Information

Dr. Tracy Smith

Medical University of South Carolina

Phone: 843 792 5164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place