Clinical trial NCT02527980: E-Cigarettes: Dynamic Patterns of Use and Health Effects
Official title: E-Cigarettes: Dynamic Patterns of Use and Health Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Nicotine Dependence
Keywords: electronic cigarettes
nicotine dependence
smoking
tobacco use
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-08-19
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 groups: regular users of electronic cigarettes and commercial cigarettes and regular exclusive users of commercial cigarettes

Brief summary: The proposed research will provide in-depth, longitudinal data, based on real-time reports, which will address key priorities for the FDA including, increased understanding of the relations between electronic cigarette (e-cig) use and 1) nicotine dependence, 2) reductions in combustible cigarette (CC) use, 3) attempts to quit CC use and the success of those attempts, and 4) health-related outcomes such as biomarkers of exposure and carcinogenicity.

Detailed description: Primary Aim: Characterize e-cig use patterns both acutely and over 2 years and relate them to patterns of CC use (including reduced CC use), nicotine dependence and related variables (e.g., withdrawal suppression), and attempts and success in quitting CC use. Investigators will use ecological momentary assessment (EMA) to obtain fine grained, real-time data on e-cig and CC use. These data will be used to test the hypotheses that increasing and higher levels of e-cig use, measured in real-time, will be negatively related to CC use, nicotine dependence, and CC withdrawal severity and positively related to CC quit attempts and CC cessation success.

Secondary Aim 1: Determine how the use of e-cigs is related to biomarkers of tobacco exposure and cancer risk, and to acute and chronic pulmonary health outcomes. Investigators will examine the relation between e-cig use and cancer biomarkers, exposure biomarkers, and pulmonary function.

Secondary Aim 2: Identify person factors, contextual variables, and patterns of behaviors and symp-toms that predict e-cig and CC use patterns and key outcomes (e.g., CC cessation, health-related outcomes), and identify variables that moderate relations between e-cig use and such outcomes. Investigators will attempt to identify contextual variables and person factors that predict increased e-cig use, decreased CC use (including cessation), reduced nicotine dependence, and significant changes in biomarkers and health outcomes. Further, investigators will identify variables that moderate such relations, revealing factors and events that make changes in e-cig and CC use, and associated outcomes, especially likely.

Eligibility criteria: Inclusion Criteria:

* Specific eligibility requirements are:

  1. ≥ 18 years old
  2. able to read and write English
  3. no plans to quit smoking and/or e-cig use in the next 30 days
  4. not currently taking smoking cessation medication
  5. not currently in treatment for psychosis or bipolar disorder
  6. participants must report either that they have:
* smoked at least 5 cigarettes per day for the past 6 months and not used e-cigs within the last 3 months ("exclusive smokers")
* used nicotine-containing e-cigs at least once a week for the past month and have smoked at least 5 CCs/day for the last 3 months ("dual users").

Exclusion Criteria:

* Individuals not meeting any one of the inclusion criteria. Those not meeting any one (or more) of criteria 1-5 and either criterion 6a or 6b will be excluded.

Primary outcomes:
measure: Characterize patterns of ecig and CC use
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: CTRI Monroe
state: Wisconsin
city: Milwaukee
country: United States
facility: CTRI Milwaukee
state: Wisconsin
Study officials:
affiliation: UW-CTRI
name: Megan E Piper, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piper ME, Baker TB, Benowitz NL, Jorenby DE. Changes in Use Patterns Over 1 Year Among Smokers and Dual Users of Combustible and Electronic Cigarettes. Nicotine Tob Res. 2020 Apr 21;22(5):672-680. doi: 10.1093/ntr/ntz065.