Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Number of choices for CC during preference task
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Heart rate greater than or equal to 115 bpm;
- •Allergy to propylene glycol or vegetable glycerin;
- •Previous adverse reaction when using vaping device or e-liquid;
- •Current or recent alcohol or drug abuse problems;
- •Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months;
- •Literate and able to independently complete and comprehend the consent form and other written study materials and measures.
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)