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

Conditions

Toxicant Exposure

Brief summary

This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.

Nicole L. Nollen, Eleanor L.S. Leavens, Jasjit S. Ahluwalia, Myra Rice, Matthew S. Mayo et al. (6 authors)

Tobacco Control2022-03-2914 citations

10.1136/tobaccocontrol-2021-057180

“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

Kim Pulvers, Myra Rice, Jasjit S. Ahluwalia, Michael J. Arnold, Crystal Marez et al. (6 authors)

Harm Reduction Journal2021-09-166 citations

10.1186/s12954-021-00543-y

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

Michael J. Arnold, Nicole L. Nollen, Matthew S. Mayo, Jasjit S. Ahluwalia, Eleanor L.S. Leavens et al. (8 authors)

Nicotine & Tobacco Research2021-04-0532 citations

10.1093/ntr/ntab069

Effect of Pod e-Cigarettes vs Cigarettes on Carcinogen Exposure Among African American and Latinx Smokers

Kim Pulvers, Nicole L. Nollen, Myra Rice, Christopher H. Schmid, Kexin Qu et al. (7 authors)

JAMA Network Open2020-11-1896 citations

10.1001/jamanetworkopen.2020.26324

Interventions

OTHERE-Cigarette Vs. Smoking as Usual

6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* \> 21 years of age * Smoked cigarettes on \> 25 of past 30 days * Smoked \> 5 cigarettes per day on days smoked * Smoked cigarettes \> 6 months * Carbon monoxide \> 5 PPM at baseline * Hispanic/Latino or African American/Black * Fluent in English or Spanish * Willing to switch from smoking cigarettes to ECs for 6 weeks * Regular access to telephone * Transportation to attend appointments (KC Only)

Exclusion criteria

* Primary use of other tobacco products or equal use of cigarettes and other tobacco products * Electronic cigarette use on \> 4 of the past 30 days * Currently in a smoking cessation program or another clinical trial * Use of nicotine replacement therapy or medication which aids smoking cessation in the past 30 days * Hospitalization for a psychiatric issue in the past 30 days * Heart-related event in the past 30 days. Examples include heart attack, stroke, severe angina (i.e. chest pain), ischemic heart disease, and vascular disease * Uncontrolled blood pressure at baseline * Planning to move out of San Diego or Kansas City in the next 6 weeks * Another person in the household enrolled in the study * Women: pregnant, breastfeeding, or planning to become pregnant in the next six months * Unstable mental status or health status

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Carbon Monoxide	6 weeks	Carbon monoxide at week 6. Breath test (PPM)
Lung Function	6 weeks	FEF 25%-75%, L/s at week 6 measured by spirometer
Systolic Blood Pressure	6 weeks	Systolic blood pressure at week 6
Respiratory Symptoms	6 weeks	Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes
Tobacco Dependence	6 weeks	Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes
Self-efficacy to Resist Smoking	6 weeks	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
Diastolic Blood Pressure	6 weeks	Diastolic blood pressure at week 6

Countries

United States

Participant flow

Participants by arm

Arm	Count
E-Cigarette 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	125
Assessment Only 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	61
Total	186

Baseline characteristics

Characteristic	Assessment Only	Total	E-Cigarette
200% federal poverty level or lower	45 Participants	138 Participants	93 Participants
Age, Continuous	41.7 years STANDARD_DEVIATION 11.9	43.3 years STANDARD_DEVIATION 12.5	44.1 years STANDARD_DEVIATION 12.7
Carbon monoxide, ppm	17 ppm	17 ppm	16 ppm
Cigarettes per day in past 7 days	11.5 cigarettes per day STANDARD_DEVIATION 6.1	12.1 cigarettes per day STANDARD_DEVIATION 7.2	12.4 cigarettes per day STANDARD_DEVIATION 7.7
Days smoked in past 7 days	6.7 days STANDARD_DEVIATION 0.9	6.8 days STANDARD_DEVIATION 0.6	6.9 days STANDARD_DEVIATION 0.5
Days used e-cigarettes in past 7 days	0.08 days STANDARD_DEVIATION 0.33	0.05 days STANDARD_DEVIATION 0.3	0.03 days STANDARD_DEVIATION 0.28
Diastolic blood pressure	83 mm Hg	82 mm Hg	81 mm Hg
Duration smoking in years	15.5 years STANDARD_DEVIATION 12.5	16.8 years STANDARD_DEVIATION 12.7	17.5 years STANDARD_DEVIATION 12.8
E-cigarette uses in past 7 days	0.09 uses per day STANDARD_DEVIATION 0.36	0.06 uses per day STANDARD_DEVIATION 0.45	0.05 uses per day STANDARD_DEVIATION 0.48
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants	94 Participants	63 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants	92 Participants	62 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
High school education or less	34 Participants	102 Participants	68 Participants
History of asthma	10 Participants	41 Participants	31 Participants
History of chronic obstructive pulmonary disorder	0 Participants	10 Participants	10 Participants
History of mental health diagnosis	30 Participants	107 Participants	77 Participants
History of substance abuse	24 Participants	88 Participants	64 Participants
Lung function, FEF 25%-75%, L/s	2.8 L/s	3.0 L/s	3.0 L/s
Menthol smoker	34 Participants	102 Participants	68 Participants
Never married	31 Participants	90 Participants	59 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants	12 Participants	8 Participants
Race (NIH/OMB) Asian	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Black or African American	30 Participants	96 Participants	66 Participants
Race (NIH/OMB) More than one race	2 Participants	11 Participants	9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	3 Participants	3 Participants
Race (NIH/OMB) White	24 Participants	60 Participants	36 Participants
Region of Enrollment United States	61 participants	186 participants	125 participants
Respiratory symptoms, number	8 units on a scale	10 units on a scale	11 units on a scale
Sex: Female, Male Female	26 Participants	75 Participants	49 Participants
Sex: Female, Male Male	35 Participants	111 Participants	76 Participants
Systolic blood pressure	129 mm Hg	129 mm Hg	130 mm Hg
Time to first cigarette 30 minutes or less	44 Participants	135 Participants	91 Participants
Urine cotinine, ng/mL	1061 ng/mL	998 ng/mL	928 ng/mL
Urine NNAL, pg/mL	88 pg/mL	110 pg/mL	124 pg/mL

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 114	0 / 54
other Total, other adverse events	46 / 114	22 / 54
serious Total, serious adverse events	0 / 114	0 / 54

Outcome results

Primary

Toxicant Exposure

Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Time frame: 6 weeks