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

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

Study Overview

• Status: Completed
• Conditions: Toxicant Exposure
• Intervention / Treatment: Other: E-Cigarette Vs. Smoking as Usual

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Marcos, California, United States, 92096
      • California State University San Marcos
  • Missouri
    • Kansas City, Missouri, United States, 64130
      • Swope Health Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-Cigarette; 6 weeks of JUUL electronic cigarettes	Other: E-Cigarette Vs. Smoking as Usual; 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
Active Comparator: Assessment Only; 6 weeks of smoking as usual	Other: E-Cigarette Vs. Smoking as Usual; 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: California State University, San Marcos
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Kim Pulvers, PhD, MPH, Associate Professor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): September 26, 2019

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1119341-85085; 1SC3GM122628 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No