Reduced Nicotine Cigarette Purchasing Decisions

Early Phase 1

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: Full Nicotine Cigarettes; Drug: Reduced Nicotine Cigarettes; Behavioral: Average Nicotine Expectancy; Behavioral: Very Low Nicotine Expectancy

• Registration Number: NCT04999644
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-11
• Study Start: 2022-02-23
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29
• Results First Submitted: 2024-01-12
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Results First Posted: 2024-02-09
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Full Nicotine Expectancy, Reduced Nicotine Dose	Average Nicotine Expectancy	Receive reduced nicotine cigarette expecting full
Full Nicotine Expectancy, Full Nicotine Dose	Full Nicotine Cigarettes	Receive full nicotine cigarette expecting full
Full Nicotine Expectancy, Full Nicotine Dose	Average Nicotine Expectancy	Receive full nicotine cigarette expecting full
Reduced Nicotine Expectancy, Full Nicotine Dose	Full Nicotine Cigarettes	Receive full nicotine cigarette expecting reduced
Reduced Nicotine Expectancy, Full Nicotine Dose	Very Low Nicotine Expectancy	Receive full nicotine cigarette expecting reduced
Reduced Nicotine Expectancy, Reduced Nicotine Dose	Reduced Nicotine Cigarettes	Receive reduced nicotine cigarette expecting reduced
Reduced Nicotine Expectancy, Reduced Nicotine Dose	Very Low Nicotine Expectancy	Receive reduced nicotine cigarette expecting reduced
Full Nicotine Expectancy, Reduced Nicotine Dose	Reduced Nicotine Cigarettes	Receive reduced nicotine cigarette expecting full

Primary Outcome Measures

Name	Time	Method
Demand Intensity	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	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 Outcome Measures

Name	Time	Method
Minnesota Nicotine Withdrawal Scale	Post-cigarette administration four times over approximately two weeks	A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome).

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit; 🇺🇸 Baltimore, Maryland, United States