E-Cigarettes: Dynamic Patterns of Use and Health Effects

NCT02527980 | Completed

• 4 other identifiers: 2015-0575A534252SMPH\MEDICINE\TOBACCO RE1R01CA190025-01
• Study Type: observational
• Target: 422
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking; Nicotine Dependence

Keywords

electronic cigarettes; nicotine dependence; smoking; tobacco use

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

dual users

Individuals who at the point of study enrollment are using both electronic cigarettes (ecig) and commercial cigarettes (CCs)

Other: No intervention: observation only

commercial cigarette (CC) only users

Individuals who at the point of study enrollment are using exclusively commercial cigarettes

Other: No intervention: observation only

Interventions

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.

commercial cigarette (CC) only users; dual users

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

2 groups: regular users of electronic cigarettes and commercial cigarettes and regular exclusive users of commercial cigarettes

You may qualify if:

• 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").

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

CTRI Monroe

Madison, Wisconsin, 53711, United States

Location

CTRI Milwaukee

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (1)

• 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.

  PMID: 31058284 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples retained for additional analyses

MeSH Terms

Conditions

Smoking; Tobacco Use Disorder; Vaping; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Megan E Piper, Phd

  UW-CTRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 19, 2015
• Study Start: October 1, 2015
• Primary Completion: July 18, 2019
• Study Completion: July 31, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)