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OpenTrials
Completed

NCT Number: NCT04999644

Reduced Nicotine Cigarette Purchasing Decisions

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.

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full Nicotine Cigarettes

Drug

A full nicotine tobacco cigarette that will be smoked by participants

Reduced Nicotine Cigarettes

Drug

A reduced nicotine tobacco cigarette that will be smoked by participants

Average Nicotine Expectancy

Behavioral

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

Very Low Nicotine Expectancy

Behavioral

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

Primary outcomes

  1. 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).

  2. 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

  1. Minnesota Nicotine Withdrawal Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2021
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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