Reduced Nicotine Cigarette Purchasing Decisions

Study Overview
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Brief Summary
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The goal of this project is to experimentally evaluate how expectations about reduced-nicotine cigarettes as well as actual nicotine content interact to determine behavioral and subjective response for these novel products.

Official Title
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Reduced Nicotine Cigarette Purchasing Decisions

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Full Nicotine Cigarettes
* Drug: Reduced Nicotine Cigarettes
* Behavioral: Average Nicotine Expectancy
* Behavioral: Very Low Nicotine Expectancy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 21 years or older Smoke five or more cigarettes per day for the past six months Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 8 ppm and a urinary cotinine level of more than 100 ng per milliliter at screening Exclusion criteria: Intention to quit smoking in the next 30 days Weekly use of nicotine-containing products other than machine-manufactured combustible cigarettes Serious medical or psychiatric disorder precluding participation by study physician guidance Positive urine screening for illicit drugs other than cannabis or current substance use disorder Women who are pregnant, plan to become pregnant, or are breast-feeding Medical contraindications to receiving tobacco products

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced Nicotine, Full Expectancy<br>Receive reduced nicotine cigarette expecting full | Drug: Reduced Nicotine Cigarettes<br>* A reduced nicotine tobacco cigarette that will be smoked by participants<br>Behavioral: Average Nicotine Expectancy<br>* Participant instructed the cigarette is the same level of nicotine as your usual brand.<br>|
| Experimental: Full Nicotine, Full Expectancy<br>Receive full nicotine cigarette expecting full | Drug: Full Nicotine Cigarettes<br>* A full nicotine tobacco cigarette that will be smoked by participants<br>Behavioral: Average Nicotine Expectancy<br>* Participant instructed the cigarette is the same level of nicotine as your usual brand.<br>|
| Experimental: Full Nicotine, Reduced Expectancy<br>Receive full nicotine cigarette expecting reduced | Drug: Full Nicotine Cigarettes<br>* A full nicotine tobacco cigarette that will be smoked by participants<br>Behavioral: Very Low Nicotine Expectancy<br>* Participant instructed the cigarette is a very low level of nicotine compared to your usual brand.<br>|
| Experimental: Reduced Nicotine, Reduced Expectancy<br>Receive reduced nicotine cigarette expecting reduced | Drug: Reduced Nicotine Cigarettes<br>* A reduced nicotine tobacco cigarette that will be smoked by participants<br>Behavioral: Very Low Nicotine Expectancy<br>* Participant instructed the cigarette is a very low level of nicotine compared to your usual brand.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demand Intensity | Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome). | 2 weeks | 
| Demand Elasticity | Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome). | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota Nicotine Withdrawal Scale | A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). | 2 weeks |