Smoking Clinical Trial
Official title:
Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Verified date | July 2023 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | May 9, 2023 |
Est. primary completion date | May 9, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: 1. Legal age to purchase tobacco products; 2. Regular user of EC and CC; 3. Owns the e-cigarette device used most often; 4. Agrees to abstain from using all tobacco products for 12 hours prior to each experimental session; 5. Self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid Exclusion Criteria: 1. Unstable medical conditions as determined by the licensed medical professional; 2. Unstable psychiatric conditions as determined by the licensed medical professional or PI; 3. Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy; 4. Serious quit attempt of either or both products in the past 3 months resulting in >30 days of abstinence; 5. Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide; 6. Plans to quit use of either EC or CC, or all tobacco products in the next 45 days; 7. Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid; 8. Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once): 1. Systolic blood pressure (BP) greater than or equal to 160 mm/hg 2. Diastolic BP greater than or equal to 100 mm/hg 3. Heart rate greater than or equal to 115 bpm; 9. Allergy to propylene glycol or vegetable glycerin; 10. Previous adverse reaction when using vaping device or e-liquid; 11. Current or recent alcohol or drug abuse problems; 12. Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months; 13. Literate and able to independently complete and comprehend the consent form and other written study materials and measures. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of choices for CC during preference task | 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. | during preference session, approximately 2 hours | |
Secondary | Number of choices for EC during preference task | Participants will complete a preference task. The number of choices for EC will be compared across the preference sessions. | during preference session, approximately 2 hours | |
Secondary | Number of choices to abstain during preference task | Participants will complete a preference task. The number of choices to abstain from any puffs will be compared across the preference sessions. | during preference session, approximately 2 hours | |
Secondary | Cigarette Evaluation Scale | 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" | during preference session, approximately 2 hours | |
Secondary | Perceived health risk | 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. | during preference session, approximately 2 hours | |
Secondary | Craving | 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 | during preference session, approximately 2 hours | |
Secondary | Product Valuation | Participants will be asked how many days per month would they use the CC product they just sampled at a variety of price increments | during preference session, approximately 2 hours | |
Secondary | CO boost | Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value | during preference session, approximately 2 hours | |
Secondary | Cross Price Elasticity | the change in demand for the session CC in response to a change in price of the session EC | during preference session, approximately 2 hours |
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