Back to resultsReduced Nicotine Cigarette Purchasing Decisions
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Full Nicotine Cigarettes
Reduced Nicotine Cigarettes
Average Nicotine Expectancy
Very Low Nicotine Expectancy
Sponsored by
About this trial
This is an interventional basic science trial for Tobacco Use Disorder
Eligibility Criteria
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
Sites / Locations
- Behavioral Pharmacology Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Reduced Nicotine, Full Expectancy
Full Nicotine, Full Expectancy
Full Nicotine, Reduced Expectancy
Reduced Nicotine, Reduced Expectancy
Arm Description
Receive reduced nicotine cigarette expecting full
Receive full nicotine cigarette expecting full
Receive full nicotine cigarette expecting reduced
Receive reduced nicotine cigarette expecting reduced
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT04999644
First Posted
July 15, 2021
Last Updated
April 10, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04999644
Brief Title
Reduced Nicotine Cigarette Purchasing Decisions
Official Title
Reduced Nicotine Cigarette Purchasing Decisions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
March 29, 2023 (Actual)
Study Completion Date
March 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reduced Nicotine, Full Expectancy
Arm Type
Experimental
Arm Description
Receive reduced nicotine cigarette expecting full
Arm Title
Full Nicotine, Full Expectancy
Arm Type
Experimental
Arm Description
Receive full nicotine cigarette expecting full
Arm Title
Full Nicotine, Reduced Expectancy
Arm Type
Experimental
Arm Description
Receive full nicotine cigarette expecting reduced
Arm Title
Reduced Nicotine, Reduced Expectancy
Arm Type
Experimental
Arm Description
Receive reduced nicotine cigarette expecting reduced
Intervention Type
Drug
Intervention Name(s)
Full Nicotine Cigarettes
Intervention Description
A full nicotine tobacco cigarette that will be smoked by participants
Intervention Type
Drug
Intervention Name(s)
Reduced Nicotine Cigarettes
Intervention Description
A reduced nicotine tobacco cigarette that will be smoked by participants
Intervention Type
Behavioral
Intervention Name(s)
Average Nicotine Expectancy
Intervention Description
Participant instructed the cigarette is "the same level of nicotine as your usual brand."
Intervention Type
Behavioral
Intervention Name(s)
Very Low Nicotine Expectancy
Intervention Description
Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."
Primary Outcome Measure Information:
Title
Demand Intensity
Description
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
2 weeks
Title
Demand Elasticity
Description
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).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Minnesota Nicotine Withdrawal Scale
Description
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
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Johnson
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Reduced Nicotine Cigarette Purchasing Decisions
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