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Clinical Trials/NCT04999644
NCT04999644
Completed
Early Phase 1

Reduced Nicotine Cigarette Purchasing Decisions

Johns Hopkins University1 site in 1 country21 target enrollmentFebruary 23, 2022

Overview

Phase
Early Phase 1
Intervention
Reduced Nicotine Cigarettes
Conditions
Tobacco Use Disorder
Sponsor
Johns Hopkins University
Enrollment
21
Locations
1
Primary Endpoint
Demand Intensity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2022
End Date
March 29, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Full Nicotine Expectancy, Reduced Nicotine Dose

Receive reduced nicotine cigarette expecting full

Intervention: Reduced Nicotine Cigarettes

Full Nicotine Expectancy, Reduced Nicotine Dose

Receive reduced nicotine cigarette expecting full

Intervention: Average Nicotine Expectancy

Full Nicotine Expectancy, Full Nicotine Dose

Receive full nicotine cigarette expecting full

Intervention: Full Nicotine Cigarettes

Full Nicotine Expectancy, Full Nicotine Dose

Receive full nicotine cigarette expecting full

Intervention: Average Nicotine Expectancy

Reduced Nicotine Expectancy, Full Nicotine Dose

Receive full nicotine cigarette expecting reduced

Intervention: Full Nicotine Cigarettes

Reduced Nicotine Expectancy, Full Nicotine Dose

Receive full nicotine cigarette expecting reduced

Intervention: Very Low Nicotine Expectancy

Reduced Nicotine Expectancy, Reduced Nicotine Dose

Receive reduced nicotine cigarette expecting reduced

Intervention: Reduced Nicotine Cigarettes

Reduced Nicotine Expectancy, Reduced Nicotine Dose

Receive reduced nicotine cigarette expecting reduced

Intervention: Very Low Nicotine Expectancy

Outcomes

Primary Outcomes

Demand Intensity

Time Frame: Four times over approximately two weeks

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).

Demand Elasticity

Time Frame: Four times over approximately two weeks

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). Values are log-transformed. Data are presented for all subjects with non-zero data (zero data cannot be analyzed with a demand function so elasticity cannot be generated)

Secondary Outcomes

  • Minnesota Nicotine Withdrawal Scale(Post-cigarette administration four times over approximately two weeks)

Study Sites (1)

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