E-Cigarettes: Dynamic Patterns of Use and Health Effects

Smoking Clinical Trial

Official title:

E-Cigarettes: Dynamic Patterns of Use and Health Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527980
• Other study ID #: 2015-0575
• Secondary ID: A534252SMPH\MEDI
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: July 31, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Tobacco Use Disorder

Intervention

Other:
• No intervention: observation only
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.

Locations

Country	Name	City	State
United States	CTRI Monroe	Madison	Wisconsin
United States	CTRI Milwaukee	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Piper ME, Baker TB, Benowitz NL, Jorenby DE. Changes in Use Patterns OVER ONE YEAR Among Smokers and Dual Users of Combustible and electronic cigarettes. Nicotine Tob Res. 2019 May 6. pii: ntz065. doi: 10.1093/ntr/ntz065. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize patterns of ecig and CC use	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).	2 years