Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
21 participants
INTERVENTIONAL
2022-02-23
2023-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Full Nicotine Expectancy, Reduced Nicotine Dose
Receive reduced nicotine cigarette expecting full
Reduced Nicotine Cigarettes
A reduced nicotine tobacco cigarette that will be smoked by participants
Average Nicotine Expectancy
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
Full Nicotine Cigarettes
A full nicotine tobacco cigarette that will be smoked by participants
Average Nicotine Expectancy
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
Full Nicotine Cigarettes
A full nicotine tobacco cigarette that will be smoked by participants
Very Low Nicotine Expectancy
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
Reduced Nicotine Cigarettes
A reduced nicotine tobacco cigarette that will be smoked by participants
Very Low Nicotine Expectancy
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
Reduced Nicotine Cigarettes
A reduced nicotine tobacco cigarette that will be smoked by participants
Average Nicotine Expectancy
Participant instructed the cigarette is "the same level of nicotine as your usual brand."
Very Low Nicotine Expectancy
Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00288837
Identifier Type: -
Identifier Source: org_study_id
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