Reduced Nicotine Cigarette Purchasing Decisions

NCT04999644 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: IRB00288837R03DA054098-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Minnesota Nicotine Withdrawal Scale

  Post-cigarette administration four times over approximately two weeks

Study Arms (4)

Full Nicotine Expectancy, Reduced Nicotine Dose

EXPERIMENTAL

Receive reduced nicotine cigarette expecting full

Drug: Reduced Nicotine Cigarettes; Behavioral: Average Nicotine Expectancy

Full Nicotine Expectancy, Full Nicotine Dose

EXPERIMENTAL

Receive full nicotine cigarette expecting full

Drug: Full Nicotine Cigarettes; Behavioral: Average Nicotine Expectancy

Reduced Nicotine Expectancy, Full Nicotine Dose

EXPERIMENTAL

Receive full nicotine cigarette expecting reduced

Drug: Full Nicotine Cigarettes; Behavioral: Very Low Nicotine Expectancy

Reduced Nicotine Expectancy, Reduced Nicotine Dose

EXPERIMENTAL

Receive reduced nicotine cigarette expecting reduced

Drug: Reduced Nicotine Cigarettes; Behavioral: Very Low Nicotine Expectancy

Interventions

Full Nicotine Cigarettes DRUG

A full nicotine tobacco cigarette that will be smoked by participants

Full Nicotine Expectancy, Full Nicotine Dose; Reduced Nicotine Expectancy, Full Nicotine Dose

Reduced Nicotine Cigarettes DRUG

A reduced nicotine tobacco cigarette that will be smoked by participants

Full Nicotine Expectancy, Reduced Nicotine Dose; Reduced Nicotine Expectancy, Reduced Nicotine Dose

Average Nicotine Expectancy BEHAVIORAL

Participant instructed the cigarette is "the same level of nicotine as your usual brand."

Full Nicotine Expectancy, Full Nicotine Dose; Full Nicotine Expectancy, Reduced Nicotine Dose

Very Low Nicotine Expectancy BEHAVIORAL

Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."

Reduced Nicotine Expectancy, Full Nicotine Dose; Reduced Nicotine Expectancy, Reduced Nicotine Dose

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Justin Strickland
• Organization: Johns Hopkins University School of Medicine

jstric14@jhmi.edu

4105501975

Study Officials

• Matthew Johnson

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 11, 2021
• Study Start: February 23, 2022
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: February 9, 2024
• Results First Posted: February 9, 2024

Record last verified: 2024-02

Locations

US (1)