E-Cigarettes: Dynamic Patterns of Use and Health Effects
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation, Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 1/12/2019 |
| Start Date: | September 2015 |
| End Date: | December 2019 |
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.
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.
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.
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.
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.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials