Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Study EC + UB CC Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC) |
Other: Study e-cigarette
E-cigarette provided by study
|
| Active Comparator: Study EC + NNC CC Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC |
Other: normal nicotine content cigarettes
Investigational combusted cigarettes with normal nicotine content
Other Names:
Other: Study e-cigarette
E-cigarette provided by study
|
| Experimental: Study EC + VLNC CC Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC |
Other: very low nicotine content cigarettes
Investigational combusted cigarettes with very low nicotine content
Other Names:
Other: Study e-cigarette
E-cigarette provided by study
|
| No Intervention: Own EC + UB CC Participants will make choices between their own EC device with their own tobacco flavor and their UB CC |
Outcome Measures
Primary Outcome Measures
- Number of choices for CC during preference task [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 Outcome Measures
- Number of choices for EC during preference task [during preference session, approximately 2 hours]
Participants will complete a preference task. The number of choices for EC will be compared across the preference sessions.
- Number of choices to abstain during preference task [during preference session, approximately 2 hours]
Participants will complete a preference task. The number of choices to abstain from any puffs will be compared across the preference sessions.
- Cigarette Evaluation Scale [during preference session, approximately 2 hours]
subjective reactions (e.g., satisfaction, dizziness) to CC product as well as how much a measure of how much they would pay for a day's worth of the product. Scale is administered on a 0-100 scale where 0 is "not at all" and 100 is "extremely"
- Perceived health risk [during preference session, approximately 2 hours]
Participants will rate on a scale from 1 (very low risk) to 7 (very high risk) their perceived risk of developing a variety of health conditions (e.g., lung cancer, heart disease, stroke) as a result of using each product.
- Craving [during preference session, approximately 2 hours]
craving rating on a scale from 1-10 [no urge to extremely strong urge] for CC and EC after product exposure relative to baseline value
- Product Valuation [during preference session, approximately 2 hours]
Participants will be asked how many days per month would they use the CC product they just sampled at a variety of price increments
- CO boost [during preference session, approximately 2 hours]
Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value
- Cross Price Elasticity [during preference session, approximately 2 hours]
the change in demand for the session CC in response to a change in price of the session EC
Eligibility Criteria
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
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Duke University
- National Institutes of Health (NIH)
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Francis McClernon, Ph.D., Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00105539
- 5R01DA048454