Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking
- Sponsor
- Duke University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Number of choices for CC during preference task
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of the study is to evaluate how limiting the nicotine content in regular cigarettes affects choices for regular cigarette and e-cigarette products. Eligible participants will be of legal age to purchase tobacco products and regularly use both e-cigarettes and regular cigarettes.
Detailed Description
Participants in this study will undergo an in-person screening session where the study will be explained in detail and participants will answer questions and provide a breath sample. During the screening session, participants will also be asked to complete surveys. Eligible participants will then complete the training procedures during which they will select an e-cigarette device to use for future preference sessions. During the 4 preference sessions, participants will sample puffs from an e-cigarette and regular cigarette and answer questions about their experience with each. They will also complete a task during which they can choose to earn puffs from the e-cigarette or regular cigarette, or choose to not take any puffs. The 4 sessions will be the same except that a different combination of e-cigarette and regular cigarette is used at each session.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Legal age to purchase tobacco products;
- •Regular user of EC and CC;
- •Owns the e-cigarette device used most often;
- •Agrees to abstain from using all tobacco products for 12 hours prior to each experimental session;
- •Self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid
Exclusion Criteria
- •Unstable medical conditions as determined by the licensed medical professional;
- •Unstable psychiatric conditions as determined by the licensed medical professional or PI;
- •Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy;
- •Serious quit attempt of either or both products in the past 3 months resulting in \>30 days of abstinence;
- •Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide;
- •Plans to quit use of either EC or CC, or all tobacco products in the next 45 days;
- •Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid;
- •Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
- •Systolic blood pressure (BP) greater than or equal to 160 mm/hg
- •Diastolic BP greater than or equal to 100 mm/hg
Outcomes
Primary Outcomes
Number of choices for CC during preference task
Time Frame: during preference session, approximately 2 hours
Participants will complete a preference task during which they will choose to take puffs from the session EC, the session CC, or to abstain from taking any puffs. A total of 10 trials will be completed. The number of choices for CC will be compared across the preference sessions.
Secondary Outcomes
- Perceived health risk(during preference session, approximately 2 hours)
- Craving(during preference session, approximately 2 hours)
- Number of choices to abstain during preference task(during preference session, approximately 2 hours)
- Cigarette Evaluation Scale(during preference session, approximately 2 hours)
- Product Valuation(during preference session, approximately 2 hours)
- Number of choices for EC during preference task(during preference session, approximately 2 hours)
- CO boost(during preference session, approximately 2 hours)
- Cross Price Elasticity(during preference session, approximately 2 hours)