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Clinical Trials/NCT04999644
NCT04999644CompletedEarly Phase 1

Reduced Nicotine Cigarette Purchasing Decisions

Johns Hopkins University1 site in 1 country21 target enrollmentStarted: February 23, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Demand Intensity

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Full Nicotine Expectancy, Reduced Nicotine Dose

Experimental

Receive reduced nicotine cigarette expecting full

Intervention: Reduced Nicotine Cigarettes (Drug)

Full Nicotine Expectancy, Reduced Nicotine Dose

Experimental

Receive reduced nicotine cigarette expecting full

Intervention: Average Nicotine Expectancy (Behavioral)

Full Nicotine Expectancy, Full Nicotine Dose

Experimental

Receive full nicotine cigarette expecting full

Intervention: Full Nicotine Cigarettes (Drug)

Full Nicotine Expectancy, Full Nicotine Dose

Experimental

Receive full nicotine cigarette expecting full

Intervention: Average Nicotine Expectancy (Behavioral)

Reduced Nicotine Expectancy, Full Nicotine Dose

Experimental

Receive full nicotine cigarette expecting reduced

Intervention: Full Nicotine Cigarettes (Drug)

Reduced Nicotine Expectancy, Full Nicotine Dose

Experimental

Receive full nicotine cigarette expecting reduced

Intervention: Very Low Nicotine Expectancy (Behavioral)

Reduced Nicotine Expectancy, Reduced Nicotine Dose

Experimental

Receive reduced nicotine cigarette expecting reduced

Intervention: Reduced Nicotine Cigarettes (Drug)

Reduced Nicotine Expectancy, Reduced Nicotine Dose

Experimental

Receive reduced nicotine cigarette expecting reduced

Intervention: Very Low Nicotine Expectancy (Behavioral)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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