NCT05177848

Brief Summary

This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 26, 2024

Completed
Last Updated

January 30, 2025

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

December 14, 2021

Results QC Date

August 30, 2024

Last Update Submit

January 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Nicotine/Tobacco Products Substitution

    Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product.

    1 day

  • Cigarette Demand

    Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0\*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity.

    1 day

Study Arms (2)

Exclusive cigarette smokers

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.

Other: All nicotine/ tobacco products at market priceOther: Nicotine vaping products at 1/2 market priceOther: Nicotine vaping products at 2x market priceOther: Heated tobacco products at 1/2 market price.Other: Heated tobacco products at 2x market price.Other: Nicotine pouch products at 1/2 market price.Other: Nicotine pouch products at 2x market price.

Dual cigarette/ nicotine vaping product users

EXPERIMENTAL

Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.

Other: All nicotine/ tobacco products at market priceOther: Nicotine vaping products at 1/2 market priceOther: Nicotine vaping products at 2x market priceOther: Heated tobacco products at 1/2 market price.Other: Heated tobacco products at 2x market price.Other: Nicotine pouch products at 1/2 market price.Other: Nicotine pouch products at 2x market price.

Interventions

Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.

Dual cigarette/ nicotine vaping product usersExclusive cigarette smokers

Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Dual cigarette/ nicotine vaping product usersExclusive cigarette smokers

Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Dual cigarette/ nicotine vaping product usersExclusive cigarette smokers

Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Dual cigarette/ nicotine vaping product usersExclusive cigarette smokers

Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Dual cigarette/ nicotine vaping product usersExclusive cigarette smokers

Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Dual cigarette/ nicotine vaping product usersExclusive cigarette smokers

Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Dual cigarette/ nicotine vaping product usersExclusive cigarette smokers

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide informed consent
  • Be at least 21 years of age or older
  • Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
  • Stable tobacco use patterns for at least three months
  • Be willing to sample NVPs, HTPs, and NPPs
  • For exclusive cigarette smokers: smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month)
  • For dual cigarette/NVP users: smoke at least 5 cigarettes daily and use NVPs for at least 3 times in a week (report use of closed nicotine salt system)

You may not qualify if:

  • Have plans to move out of the area
  • Have a serious or unstable physical or mental health condition
  • Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement
  • Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Cigarette SmokingVaping

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Results Point of Contact

Title
Dr. Roberta Freitas-Lemos
Organization
Fralin Biomedical Research Institute at VTC

Study Officials

  • Warren K Bickel, Ph.D.

    Fralin Biomedical Research Institute at VTC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price, market price, and 2x market price).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 5, 2022

Study Start

June 29, 2022

Primary Completion

June 2, 2023

Study Completion

June 7, 2023

Last Updated

January 30, 2025

Results First Posted

September 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

The study team will share de-identified data upon request.

Locations