Reduced Nicotine Cigarette Purchasing Decisions

Tobacco Use Disorder Clinical Trial

Official title:

Reduced Nicotine Cigarette Purchasing Decisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04999644
• Other study ID #: IRB00288837
• Secondary ID: R03DA054098-01
• Status: Completed
• Phase: Early Phase 1
• Start date: February 23, 2022
• Est. completion date: March 29, 2023

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• 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

Behavioral:
• 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."

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Four times over approximately two weeks
Primary	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). 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)	Four times over approximately two weeks
Secondary	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).	Post-cigarette administration four times over approximately two weeks