Reduced Nicotine Cigarette Purchasing Decisions

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04999644
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
20
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4
10.2
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Full Nicotine Cigarettes
  • Drug: Reduced Nicotine Cigarettes
  • Behavioral: Average Nicotine Expectancy
  • Behavioral: Very Low Nicotine Expectancy
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Reduced Nicotine Cigarette Purchasing Decisions
Actual Study Start Date :
Feb 23, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reduced Nicotine, Full Expectancy

Receive reduced nicotine cigarette expecting full

Drug: Reduced Nicotine Cigarettes
A reduced nicotine tobacco cigarette that will be smoked by participants

Behavioral: Average Nicotine Expectancy
Participant instructed the cigarette is "the same level of nicotine as your usual brand."

Experimental: Full Nicotine, Full Expectancy

Receive full nicotine cigarette expecting full

Drug: Full Nicotine Cigarettes
A full nicotine tobacco cigarette that will be smoked by participants

Behavioral: Average Nicotine Expectancy
Participant instructed the cigarette is "the same level of nicotine as your usual brand."

Experimental: Full Nicotine, Reduced Expectancy

Receive full nicotine cigarette expecting reduced

Drug: Full Nicotine Cigarettes
A full nicotine tobacco cigarette that will be smoked by participants

Behavioral: Very Low Nicotine Expectancy
Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."

Experimental: Reduced Nicotine, Reduced Expectancy

Receive reduced nicotine cigarette expecting reduced

Drug: Reduced Nicotine Cigarettes
A reduced nicotine tobacco cigarette that will be smoked by participants

Behavioral: Very Low Nicotine Expectancy
Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."

Outcome Measures

Primary Outcome Measures

  1. Demand Intensity [2 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 [2 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).

Secondary Outcome Measures

  1. Minnesota Nicotine Withdrawal Scale [2 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Behavioral Pharmacology Research Unit Baltimore Maryland United States 21224

Sponsors and Collaborators

  • Johns Hopkins University
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Matthew Johnson, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04999644
Other Study ID Numbers:
  • IRB00288837
  • R03DA054098-01
First Posted:
Aug 11, 2021
Last Update Posted:
Jun 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2022