Cigarette Smoking Clinical Trial
Official title:
Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type
| Verified date | June 2023 |
| Source | Virginia Polytechnic Institute and State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | June 12, 2023 |
| Est. primary completion date | June 12, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | Inclusion Criteria: - Provide informed consent - Be at least 21 years of age or older - Provide a breath sample for measuring carbon monoxide (CO = 8 ppm) - Stable tobacco use patterns for at least three months - Be willing to sample NVPs, HTPs, and NPPs - For exclusive cigarette smokers: smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month) - For dual cigarette/NVP users: smoke at least 5 cigarettes daily and use NVPs for at least 3 times in a week (report use of closed nicotine salt system) Exclusion Criteria: - Have plans to move out of the area - Have a serious or unstable physical or mental health condition - Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement - Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study |
| Country | Name | City | State |
|---|---|---|---|
| United States | Fralin Biomedical Research Institute | Roanoke | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Virginia Polytechnic Institute and State University | Medical University of South Carolina, National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Nicotine/tobacco products substitution | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed.
To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product. |
1 day | |
| Primary | Cigarette demand | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed.
To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0*10k(exp(-aQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and a is the demand elasticity. |
1 day |
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