Reduced Nicotine Cigarette Purchasing Decisions

NCT ID: NCT04999644

Last Updated: 2024-02-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2023-03-29

Brief Summary

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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

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Full Nicotine Expectancy, Reduced Nicotine Dose

Receive reduced nicotine cigarette expecting full

Group Type EXPERIMENTAL

Reduced Nicotine Cigarettes

Intervention Type DRUG

A reduced nicotine tobacco cigarette that will be smoked by participants

Average Nicotine Expectancy

Intervention Type BEHAVIORAL

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

Full Nicotine Expectancy, Full Nicotine Dose

Receive full nicotine cigarette expecting full

Group Type EXPERIMENTAL

Full Nicotine Cigarettes

Intervention Type DRUG

A full nicotine tobacco cigarette that will be smoked by participants

Average Nicotine Expectancy

Intervention Type BEHAVIORAL

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

Reduced Nicotine Expectancy, Full Nicotine Dose

Receive full nicotine cigarette expecting reduced

Group Type EXPERIMENTAL

Full Nicotine Cigarettes

Intervention Type DRUG

A full nicotine tobacco cigarette that will be smoked by participants

Very Low Nicotine Expectancy

Intervention Type BEHAVIORAL

Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."

Reduced Nicotine Expectancy, Reduced Nicotine Dose

Receive reduced nicotine cigarette expecting reduced

Group Type EXPERIMENTAL

Reduced Nicotine Cigarettes

Intervention Type DRUG

A reduced nicotine tobacco cigarette that will be smoked by participants

Very Low Nicotine Expectancy

Intervention Type BEHAVIORAL

Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."

Interventions

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Full Nicotine Cigarettes

A full nicotine tobacco cigarette that will be smoked by participants

Intervention Type DRUG

Reduced Nicotine Cigarettes

A reduced nicotine tobacco cigarette that will be smoked by participants

Intervention Type DRUG

Average Nicotine Expectancy

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

Intervention Type BEHAVIORAL

Very Low Nicotine Expectancy

Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Johnson

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R03DA054098-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00288837

Identifier Type: -

Identifier Source: org_study_id

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