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Completed

NCT Number: NCT02527980

E-Cigarettes: Dynamic Patterns of Use and Health Effects

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CTRI Monroe, Madison, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Specific eligibility requirements are:
  • ≥ 18 years old
  • able to read and write English
  • no plans to quit smoking and/or e-cig use in the next 30 days
  • not currently taking smoking cessation medication
  • not currently in treatment for psychosis or bipolar disorder
  • 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.

Treatment and study plan

No intervention: observation only

Other

For all participants: We will conduct a 2-year longitudinal cohort study comprising participants who smoke exclusively CCs (n=175) and dual users of e-cigs and CCs (n=275). We will use state-of-the-art ecological momentary assessments to determine: 1) dynamic patterns of e-cig and CC use and related outcomes (e.g., dependence, withdrawal symptoms, CC quit attempts and quitting success); 2) episodic (affective, contextual, social) and stable person-factor (lifestyle factors, demographics) variables that covary meaningfully with e-cig and CC use and related outcomes; and 3) biomarkers of tobacco and carcinogen exposure as well as other health-related outcomes (e.g., reduced pulmonary function.

Primary outcomes

  1. Characterize patterns of ecig and CC use

    Time frame: 2 years

    To address the primary aim of understanding dynamic use patterns in an observational cohort, investigators will assess the use of CCs, e-cigs and other tobacco use-related behavior. E-cig attitudinal questions and questions about e-cig use in the environment will be asked. Investigators will assess person factors that may inform understanding of who is using e-cigs and in what manner these may also moderate the effects of e-cig use. Investigators will also use ecological momentary assessment (EMA) to obtain data on e-cig and CC use. Investigators will assess exhaled carbon dioxide, cotinine and polycyclic aromatic hydrocarbons (PAHs). Pulmonary function will be assessed via spirometry conducted in accordance with the American Thoracic Society guidelines. Investigators will also assess prior pulmonary diagnoses. Participants will also complete the St. George Respiratory Questionnaire for chronic obstructive pulmonary disease (SGRQ-C).

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2015
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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