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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Reduced Nicotine Cigarettes; Behavioral: Average Nicotine Expectancy; Drug: Full Nicotine Cigarettes; Behavioral: Very Low Nicotine Expectancy

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Behavioral Pharmacology Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full Nicotine Expectancy, Reduced Nicotine Dose; 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 Expectancy, Full Nicotine Dose; Receive full nicotine cigarette expecting full	Behavioral: Average Nicotine Expectancy; Participant instructed the cigarette is "the same level of nicotine as your usual brand."; Drug: Full Nicotine Cigarettes; A full nicotine tobacco cigarette that will be smoked by participants
Experimental: Reduced Nicotine Expectancy, Full Nicotine Dose; 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 Expectancy, Reduced Nicotine Dose; 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Matthew Johnson, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: IRB00288837; R03DA054098-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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