Clinical trial NCT03511001: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Official title: Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toxicant Exposure
Lead sponsor: California State University, San Marcos
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-04-27
Enrollment: 187
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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

Primary outcomes:
measure: Toxicant Exposure
timeFrame: 6 weeks
Secondary outcomes:
measure: Carbon Monoxide
timeFrame: 6 weeks
measure: Respiratory Symptoms
timeFrame: 6 weeks
measure: Lung Function
timeFrame: 6 weeks
measure: Systolic Blood Pressure
timeFrame: 6 weeks
measure: Diastolic Blood Pressure
timeFrame: 6 weeks
measure: Tobacco Dependence
timeFrame: 6 weeks
measure: Self-efficacy to Resist Smoking
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: California State University San Marcos
state: California
city: Kansas City
country: United States
facility: Swope Health Central
state: Missouri
Study officials:
affiliation: Associate Professor
name: Kim Pulvers, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.