Reduced Nicotine Cigarette Purchasing Decisions

Early Phase 1CompletedNCT04999644

Johns Hopkins University21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Tobacco Use Disorder

Interventions

Full Nicotine CigarettesDRUG

A full nicotine tobacco cigarette that will be smoked by participants

Reduced Nicotine CigarettesDRUG

A reduced nicotine tobacco cigarette that will be smoked by participants

Average Nicotine ExpectancyBEHAVIORAL

Participant instructed the cigarette is "the same level of nicotine as your usual brand."

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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).

Time frame: Four times over approximately two 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). 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)

Time frame: Four times over approximately two weeks

Secondary Outcomes

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).

Time frame: Post-cigarette administration four times over approximately two weeks

Data from ClinicalTrials.gov

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