Impact of New Product Standards for JUUL Among Dual JUUL/Combusted Cigarette Users

NCT04179617 | Withdrawn

• 1 other identifier: Pro00103010
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To date the majority of experimental tobacco regulatory science has focused specifically on the impact of possible tobacco product standards (e.g. limiting e-cigarette flavor) on the use of the single tobacco product targeted by the standard (e.g. e-cigarettes) among individuals who primarily or solely use the targeted product (e.g. vapers). Whereas this "single target" approach has yielded a large amount of actionable evidence, it has also resulted in a significant gap in the regulatory science evidence base for two reasons: First, the focus on single tobacco product users has resulted in very little evidence regarding the impact of possible new product standards among multiple tobacco product (MTP) users. MTP users make up a sizeable proportion (30-40%) of the tobacco using population and individuals who use e-cigarettes (EC) and combusted cigarettes (CC) comprise the largest MTP using group (40% of MTP users). A lack of data on this population means that estimates of the impact of new product standards on public health are incomplete. Despite some data derived from hypothetical tasks, little experimental research exists to evaluate how potential tobacco regulations might impact the use of other tobacco products in addition to the targeted product. It is critical to anticipate how potential restrictions on the EC market may impact EC and other tobacco product-such as CC-use. In the proposed research, we will recruit young adult (age 21-29) dual EC/CC users evaluate the demand for participants' usual brand CC as compared to EC that vary in nicotine content (e.g., 5% vs. 3% pods). Participants will engage in a validated concurrent choice task in which they will work for fixed doses of EC vapor or CC smoke in exchange for expended effort. In addition, we will seek to answer this question in samples of dual EC and CC users-individuals who, because they regularly use both EC and CC, are most vulnerable to changes in the appeal of EC and CC brought about by a product standard limiting EC flavors.

Conditions

Smoking; E-cigarette Use; Cigarette Smoking

Keywords

JUUL; dual use; multiple tobacco product use; nicotine content; tobacco regulatory science

Outcome Measures

Primary Outcomes (7)

• Participant rating of how much they liked the product

  Participants are asked the question: "How much do you like the product?" and asked to rate it on a scale from 0-100 (0 = not at all, 100 = extremely)

  Within 2 minutes of sampling product(s)

• Participant rating of whether or not they would use the product again

  Participants are asked the question: "Would you use it again?" and asked to rate it on a scale from 0-100 (0 = not at all, 100 = definitely)

  Within 2 minutes of sampling product(s)

• Participant rating of how much they would pay for a day's worth of the product

  Participants are asked the question: "How much would you pay for a day's worth?" and asked to rate it on a scale from $0-$100

  Within 2 minutes of sampling product(s)

• Mean puff volume taken when using JUUL

  A topography device will measure the volume of the 4 puffs taken when using JUUL during the Appeal Phase of the study; an average of the volume of these 4 puffs will be calculated

  Measurements taken over the course of a 5-minute window during the Appeal Phase

• Mean puff volume taken when using combusted cigarettes

  A topography device will measure the volume of the 4 puffs taken when using a combusted cigarette during the Appeal Phase of the study; an average of the volume of these 4 puffs will be calculated

  Measurements taken over the course of a 5-minute window during the Appeal Phase

• Number of ratios completed for JUUL

  The number of ratios completed (during a Progressive Ratio Task) to earn a puff of JUUL will be calculated

  The number of ratios completed will be calculated over a 1-hour period during the Reinforcement Phase

• Number of ratios completed for combusted cigarettes

  The number of ratios completed (during a Progressive Ratio Task) to earn a puff of a combusted cigarette will be calculated

  The number of ratios completed will be calculated over a 1-hour period during the Reinforcement Phase

Study Arms (2)

Preferred nicotine content JUUL pod

EXPERIMENTAL

During one experimental visit, participants will have access to a JUUL loaded with a 5% nicotine content pod (their preferred pod)

Other: 5% nicotine content JUUL pod

Low nicotine content JUUL pod

EXPERIMENTAL

During one experimental visit, participants will have access to a JUUL loaded with a 3% nicotine content pod (non-preferred pod)

Other: 3% nicotine content JUUL pod

Interventions

5% nicotine content JUUL pod OTHER

JUUL pods that contain 5% nicotine

Preferred nicotine content JUUL pod

3% nicotine content JUUL pod OTHER

JUUL pods that contain 3% nicotine

Low nicotine content JUUL pod

Eligibility Criteria

• Age: 21 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 21-29 inclusive;
• Combusted cigarette smoker for ≥3 months AND smoke combusted cigarettes ≥1 day/past week;
• Owner and user of JUUL brand e-cigarette for ≥3 months AND use JUUL ≥1 day/ past week;
• Current or previous use of JUUL branded pods;
• Breath alcohol level=0.000;
• Provided contact information for 2 individuals who can corroborate JUUL EC and CC use
• Willing to abstain from EC and CC use for 24 hours prior to Experimental Visits

You may not qualify if:

• Reporting that 3% nicotine content JUUL pods are their preferred nicotine content;
• Reporting that nicotine-free pods are their preferred pod;
• Vaping THC or CBD concentrates (e.g., oils, waxes, shatters, crumbles) in the past 3 months;
• Pregnant, trying to become pregnant, breastfeeding;
• Plans to quit using e-cigarettes or regular cigarettes in the next 30 days;
• Current use of smoking cessation aids or participation in smoking cessation treatment;
• Allergies to propylene glycol or glycerin;
• Lung or breathing problems (e.g., asthma, COPD, bronchitis) within the past 3 months;
• Systolic blood pressure ≥160 mmHg;
• Diastolic blood pressure ≥100 mmHg;
• Heart rate ≥115 bpm

Sponsors & Collaborators

• Duke University: lead
• University of Michigan: collaborator
• Georgetown University: collaborator

MeSH Terms

Conditions

Smoking; Vaping; Cigarette Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Lauren Pacek, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 27, 2019
• Study Start: October 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share