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

NCT03511001 | Completed Results

• 2 other identifiers: 1119341-850851SC3GM122628
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Toxicant Exposure

Outcome Measures

Primary Outcomes (1)

• Toxicant Exposure

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

  6 weeks

Secondary Outcomes (7)

• Carbon Monoxide

  6 weeks

• Respiratory Symptoms

  6 weeks

• Lung Function

  6 weeks

• Systolic Blood Pressure

  6 weeks

• Diastolic Blood Pressure

  6 weeks

Study Arms (2)

E-Cigarette

EXPERIMENTAL

6 weeks of JUUL electronic cigarettes

Other: E-Cigarette Vs. Smoking as Usual

Assessment Only

ACTIVE COMPARATOR

6 weeks of smoking as usual

Other: E-Cigarette Vs. Smoking as Usual

Interventions

E-Cigarette Vs. Smoking as Usual OTHER

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

Assessment Only; E-Cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• California State University, San Marcos: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (2)

California State University San Marcos

San Marcos, California, 92096, United States

Location

Swope Health Central

Kansas City, Missouri, 64130, United States

Location

Related Publications (4)

• 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. 2023 Nov;32(6):786-789. doi: 10.1136/tobaccocontrol-2021-057180. Epub 2022 Mar 29.

  PMID: 35351805 DERIVED

• 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.

  PMID: 34530834 DERIVED

• 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.

  PMID: 33837422 DERIVED

• 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.

  PMID: 33206193 DERIVED

Results Point of Contact

• Title: Dr. Kim Pulvers
• Organization: California State University San Marcos

kpulvers@csusm.edu

760 750 4127

Study Officials

• Kim Pulvers, PhD, MPH

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 27, 2018
• Study Start: May 17, 2018
• Primary Completion: May 10, 2019
• Study Completion: September 26, 2019
• Last Updated: October 12, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-08

Locations

US (2)