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

Tracking Information

• First Submitted Date: April 10, 2018
• First Posted Date: April 27, 2018
• Results First Submitted Date: February 4, 2021
• Results First Posted Date: September 5, 2021
• Last Update Posted Date: October 12, 2021
• Actual Study Start Date: May 17, 2018
• Actual Primary Completion Date: May 10, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 8, 2021)

Toxicant Exposure [ Time Frame: 6 weeks ]

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

Original Primary Outcome Measures (submitted: April 18, 2018)

Change in toxicant exposure [ Time Frame: Up to 6 weeks ]

NNAL

Current Secondary Outcome Measures (submitted: October 8, 2021)

• Carbon Monoxide [ Time Frame: 6 weeks ]
  Carbon monoxide at week 6. Breath test (PPM)
• 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
• Lung Function [ Time Frame: 6 weeks ]
  FEF 25%-75%, L/s at week 6 measured by spirometer
• Systolic Blood Pressure [ Time Frame: 6 weeks ]
  Systolic blood pressure at week 6
• Diastolic Blood Pressure [ Time Frame: 6 weeks ]
  Diastolic blood pressure at week 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
• 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

Original Secondary Outcome Measures (submitted: April 18, 2018)

• Carbon monoxide [ Time Frame: Up to 6 weeks ]
  Breath test (PPM)
• Blood pressure [ Time Frame: Up to 6 weeks ]
  Diastolic and systolic
• Lung function [ Time Frame: Up to 6 weeks ]
  Spirometry
• Respiratory symptoms [ Time Frame: Up to 6 weeks ]
  American Thoracic Society Questionnaire
• Tobacco dependence [ Time Frame: Up to 6 weeks ]
  Validated questions from PATH
• Self-efficacy to resist smoking [ Time Frame: Up to 6 weeks ]
  Brief Self Efficacy to Resist Smoking Cigarettes Scale

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
• Official Title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
• Brief Summary: This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• 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

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

Study Arms

• Experimental: E-Cigarette
  6 weeks of JUUL electronic cigarettes
  Intervention: Other: E-Cigarette Vs. Smoking as Usual
• Active Comparator: Assessment Only
  6 weeks of smoking as usual
  Intervention: Other: E-Cigarette Vs. Smoking as Usual

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 11, 2019): 187
• Original Estimated Enrollment (submitted: April 18, 2018): 180
• Actual Study Completion Date: September 26, 2019
• Actual Primary Completion Date: May 10, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03511001
• Other Study ID Numbers: 1119341-85085; 1SC3GM122628 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: California State University, San Marcos
• Original Responsible Party: Same as current
• Current Study Sponsor: California State University, San Marcos
• Original Study Sponsor: Same as current
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Investigators

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

• PRS Account: California State University, San Marcos
• Verification Date: August 2021