Effects Among Smokers Who Use and Do Not Use E-Cigarettes

• ClinicalTrials.gov Identifier: NCT03511001
• Recruitment Status: Completed
• First Posted: April 27, 2018
• Results First Posted: September 5, 2021
• Last Update Posted: October 12, 2021
• Sponsor: California State University, San Marcos
• Collaborator: National Institute of General Medical Sciences (NIGMS)
• Information provided by (Responsible Party): California State University, San Marcos

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Toxicant Exposure
• Intervention: Other: E-Cigarette Vs. Smoking as Usual
• Enrollment: 187

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Period Title: Overall Study
Started	126	61
Completers Analyzed	114 [1]	61
Completed	115	54
Not Completed	11	7
[1] 1 participant was excluded post-randomization due to not meeting race/ethnicity inclusion criteria.

Baseline Characteristics

Arm/Group Title		E-Cigarette	Assessment Only	Total
Arm/Group Description		6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	Total of all reporting groups
Overall Number of Baseline Participants		125	61	186
Baseline Analysis Population Description		One post-randomization exclusion from analyses due to not meeting race/ethnicity inclusion criteria
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	125 participants	61 participants	186 participants
		44.1 (12.7)	41.7 (11.9)	43.3 (12.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
	Female	49 39.2%	26 42.6%	75 40.3%
	Male	76 60.8%	35 57.4%	111 59.7%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
	Hispanic or Latino	63 50.4%	31 50.8%	94 50.5%
	Not Hispanic or Latino	62 49.6%	30 49.2%	92 49.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
	American Indian or Alaska Native	8 6.4%	4 6.6%	12 6.5%
	Asian	1 0.8%	1 1.6%	2 1.1%
	Native Hawaiian or Other Pacific Islander	2 1.6%	0 0.0%	2 1.1%
	Black or African American	66 52.8%	30 49.2%	96 51.6%
	White	36 28.8%	24 39.3%	60 32.3%
	More than one race	9 7.2%	2 3.3%	11 5.9%
	Unknown or Not Reported	3 2.4%	0 0.0%	3 1.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	125 participants	61 participants	186 participants
		125	61	186
High school education or less; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		68 54.4%	34 55.7%	102 54.8%
200% federal poverty level or lower; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		93 74.4%	45 73.8%	138 74.2%
Never married; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		59 47.2%	31 50.8%	90 48.4%
Menthol smoker; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		68 54.4%	34 55.7%	102 54.8%
Duration smoking in years; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	125 participants	61 participants	186 participants
		17.5 (12.8)	15.5 (12.5)	16.8 (12.7)
Time to first cigarette 30 minutes or less [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		91 72.8%	44 72.1%	135 72.6%
		[1] Measure Description: Participants were asked how soon after waking they typically smoked first cigarette of the day. Response options included within 30 minutes of waking or after 30 minutes of waking.
Days smoked in past 7 days; Mean (Standard Deviation); Unit of measure: Days
	Number Analyzed	125 participants	61 participants	186 participants
		6.9 (0.5)	6.7 (0.9)	6.8 (0.6)
Cigarettes per day in past 7 days; Mean (Standard Deviation); Unit of measure: Cigarettes per day
	Number Analyzed	125 participants	61 participants	186 participants
		12.4 (7.7)	11.5 (6.1)	12.1 (7.2)
Days used e-cigarettes in past 7 days; Mean (Standard Deviation); Unit of measure: Days
	Number Analyzed	125 participants	61 participants	186 participants
		0.03 (0.28)	0.08 (0.33)	0.05 (0.30)
E-cigarette uses in past 7 days; Mean (Standard Deviation); Unit of measure: Uses per day
	Number Analyzed	125 participants	61 participants	186 participants
		0.05 (0.48)	0.09 (0.36)	0.06 (0.45)
History of chronic obstructive pulmonary disorder; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		10 8.0%	0 0.0%	10 5.4%
History of asthma; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		31 24.8%	10 16.4%	41 22.0%
History of mental health diagnosis; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		77 61.6%	30 49.2%	107 57.5%
History of substance abuse; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	125 participants	61 participants	186 participants
		64 51.2%	24 39.3%	88 47.3%
Urine cotinine, ng/mL; Median (Inter-Quartile Range); Unit of measure: ng/mL
	Number Analyzed	125 participants	61 participants	186 participants
		928; (463 to 1476)	1061; (534 to 1720)	998; (480 to 1653)
Urine NNAL, pg/mL; Median (Inter-Quartile Range); Unit of measure: pg/mL
	Number Analyzed	125 participants	61 participants	186 participants
		124; (45 to 197)	88; (58 to 197)	110; (52 to 197)
Carbon monoxide, ppm; Median (Inter-Quartile Range); Unit of measure: Ppm
	Number Analyzed	125 participants	61 participants	186 participants
		16; (11 to 22)	17; (11 to 25)	17; (11 to 23)
Lung function, FEF 25%-75%, L/s; Median (Inter-Quartile Range); Unit of measure: L/s
	Number Analyzed	125 participants	61 participants	186 participants
		3.0; (2.1 to 4.1)	2.8; (2.1 to 4.0)	3.0; (2.1 to 4.1)
Respiratory symptoms, number [1]; Median (Inter-Quartile Range); Unit of measure: Units on a scale
	Number Analyzed	125 participants	61 participants	186 participants
		11; (5 to 18)	8; (4 to 13)	10; (5 to 17)
		[1] Measure Description: American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes
Systolic blood pressure; Median (Inter-Quartile Range); Unit of measure: Mm Hg
	Number Analyzed	125 participants	61 participants	186 participants
		130; (115 to 142)	129; (118 to 140)	129; (116 to 142)
Diastolic blood pressure; Median (Inter-Quartile Range); Unit of measure: Mm Hg
	Number Analyzed	125 participants	61 participants	186 participants
		81; (76 to 89)	83; (74 to 88)	82; (76 to 89)

Outcome Measures

1. Primary Outcome

Title	Toxicant Exposure
Description	Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description:	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Overall Number of Participants Analyzed	114	54
Median (Inter-Quartile Range); Unit of Measure: pg/ml
	40; (12 to 101)	97; (39 to 222)

2. Secondary Outcome

Title	Carbon Monoxide
Description	Carbon monoxide at week 6. Breath test (PPM)
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description:	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Overall Number of Participants Analyzed	114	54
Median (Inter-Quartile Range); Unit of Measure: ppm
	7; (3 to 14)	16; (9 to 25)

3. Secondary Outcome

Title	Respiratory Symptoms
Description	Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description:	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Overall Number of Participants Analyzed	114	54
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	7; (3 to 12)	9; (4 to 16)

4. Secondary Outcome

Title	Lung Function
Description	FEF 25%-75%, L/s at week 6 measured by spirometer
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description:	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Overall Number of Participants Analyzed	114	54
Median (Inter-Quartile Range); Unit of Measure: L/sec
	2.8; (1.8 to 4.1)	2.7; (2.1 to 4.1)

5. Secondary Outcome

Title	Systolic Blood Pressure
Description	Systolic blood pressure at week 6
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description:	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Overall Number of Participants Analyzed	114	54
Median (Inter-Quartile Range); Unit of Measure: mmHg
	128; (117 to 142)	133; (122 to 143)

6. Secondary Outcome

Title	Diastolic Blood Pressure
Description	Diastolic blood pressure at week 6
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description:	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Overall Number of Participants Analyzed	114	54
Median (Inter-Quartile Range); Unit of Measure: mmHg
	83; (74 to 89)	83; (75 to 89)

7. Secondary Outcome

Title	Tobacco Dependence
Description	Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description:	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Overall Number of Participants Analyzed	114	54
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	18.5; (15.0 to 36.3)	41.0; (33.8 to 57.5)

8. Secondary Outcome

Title	Self-efficacy to Resist Smoking
Description	Self-efficacy to resist smoking at week 6. Brief Self Efficacy to Resist Smoking Cigarettes Scale; total score ranges from 0-60, higher score reflects better outcome
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114.

Arm/Group Title	E-Cigarette	Assessment Only
Arm/Group Description:	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual	6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Overall Number of Participants Analyzed	114	54
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	43.0; (26.5 to 56.0)	20.0; (12.5 to 30.5)

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	E-Cigarette		Assessment Only
Arm/Group Description	6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual		6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
All-Cause Mortality
	E-Cigarette		Assessment Only
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/114 (0.00%)		0/54 (0.00%)
Serious Adverse Events
	E-Cigarette		Assessment Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0.00%)		0/54 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	E-Cigarette		Assessment Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/114 (40.35%)		22/54 (40.74%)
Cardiac disorders
Rapid Heart Rate †	18/114 (15.79%)	18	12/54 (22.22%)	12
Gastrointestinal disorders
Nauseau and/or Vomiting †	19/114 (16.67%)	19	11/54 (20.37%)	11
Nervous system disorders
Dizziness †	19/114 (16.67%)	19	14/54 (25.93%)	14
Respiratory, thoracic and mediastinal disorders
Dry Mouth/Throat †	46/114 (40.35%)	46	22/54 (40.74%)	22
Irritated Mouth/Throat †	24/114 (21.05%)	24	11/54 (20.37%)	11
† Indicates events were collected by systematic assessment

Limitations and 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.

Results Point of Contact

• Name/Title: Dr. Kim Pulvers
• Organization: California State University San Marcos
• Phone: 760 750 4127
• EMail: kpulvers@csusm.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nollen NL, Leavens ELS, Ahluwalia JS, Rice M, Mayo MS, Pulvers K. Menthol versus non-menthol flavouring and switching to e-cigarettes in black and Latinx adult menthol combustible cigarette smokers: secondary analyses from a randomised clinical trial. Tob Control. 2022 Mar 29:tobaccocontrol-2021-057180. doi: 10.1136/tobaccocontrol-2021-057180. Online ahead of print.

Pulvers K, Rice M, Ahluwalia JS, Arnold MJ, Marez C, Nollen NL. "It is the One Thing that has Worked": facilitators and barriers to switching to nicotine salt pod system e-cigarettes among African American and Latinx people who smoke: a content analysis. Harm Reduct J. 2021 Sep 16;18(1):98. doi: 10.1186/s12954-021-00543-y.

Arnold MJ, Nollen NL, Mayo MS, Ahluwalia JS, Leavens EL, Zhang G, Rice M, Pulvers K. Harm Reduction Associated with Dual Use of Cigarettes and e-Cigarettes in Black and Latino Smokers: Secondary Analyses from a Randomized Controlled e-Cigarette Switching Trial. Nicotine Tob Res. 2021 Oct 7;23(11):1972-1976. doi: 10.1093/ntr/ntab069.

Pulvers K, Nollen NL, Rice M, Schmid CH, Qu K, Benowitz NL, Ahluwalia JS. Effect of Pod e-Cigarettes vs Cigarettes on Carcinogen Exposure Among African American and Latinx Smokers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2026324. doi: 10.1001/jamanetworkopen.2020.26324.

• Responsible Party: California State University, San Marcos
• ClinicalTrials.gov Identifier: NCT03511001
• Other Study ID Numbers: 1119341-85085; 1SC3GM122628 ( U.S. NIH Grant/Contract )
• First Submitted: April 10, 2018
• First Posted: April 27, 2018
• Results First Submitted: February 4, 2021
• Results First Posted: September 5, 2021
• Last Update Posted: October 12, 2021