Reduced Nicotine Cigarette Purchasing Decisions

Johns Hopkins University

Status and phase: Completed; Early Phase 1

Conditions: Tobacco Use Disorder

Treatments: Drug: Full Nicotine Cigarettes; Behavioral: Average Nicotine Expectancy; Drug: Reduced Nicotine Cigarettes; Behavioral: Very Low Nicotine Expectancy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04999644

IRB00288837

R03DA054098-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 4 patient groups

Full Nicotine Expectancy, Reduced Nicotine Dose

Experimental group

Description:

Receive reduced nicotine cigarette expecting full

Treatment:

Behavioral: Average Nicotine Expectancy

Drug: Reduced Nicotine Cigarettes

Full Nicotine Expectancy, Full Nicotine Dose

Experimental group

Description:

Receive full nicotine cigarette expecting full

Treatment:

Drug: Full Nicotine Cigarettes

Behavioral: Average Nicotine Expectancy

Reduced Nicotine Expectancy, Full Nicotine Dose

Experimental group

Description:

Receive full nicotine cigarette expecting reduced

Treatment:

Drug: Full Nicotine Cigarettes

Behavioral: Very Low Nicotine Expectancy

Reduced Nicotine Expectancy, Reduced Nicotine Dose

Experimental group

Description:

Receive reduced nicotine cigarette expecting reduced

Treatment:

Behavioral: Very Low Nicotine Expectancy

Drug: Reduced Nicotine Cigarettes