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 Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Toxicant Exposure	Other: E-Cigarette Vs. Smoking as Usual	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 187 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
• Actual Study Start Date: May 17, 2018
• Actual Primary Completion Date: May 10, 2019
• Actual Study Completion Date: September 26, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

California State University San Marcos

San Marcos, California, United States, 92096

United States, Missouri

Swope Health Central

Kansas City, Missouri, United States, 64130

Sponsors and Collaborators

California State University, San Marcos

National Institute of General Medical Sciences (NIGMS)

Investigators

• Principal Investigator: Kim Pulvers, PhD, MPH; Associate Professor

  Study Documents (Full-Text)

Documents provided by California State University, San Marcos:

Study Protocol  [PDF] April 23, 2018

No Statistical Analysis Plan (SAP) exists for this study.

More Information

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 Posted: April 27, 2018
• Results First Posted: September 5, 2021
• Last Update Posted: October 12, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No