Skip to main content
OpenTrials
Completed

NCT Number: NCT05473585

Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2

The purpose of the study is to evaluate how limiting the nicotine content in regular cigarettes affects choices for regular cigarette and e-cigarette products. Eligible participants will be of legal age to purchase tobacco products and regularly use both e-cigarettes and regular cigarettes.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

Participants in this study will undergo an in-person screening session where the study will be explained in detail and participants will answer questions and provide a breath sample. During the screening session, participants will also be asked to complete surveys. Eligible participants will then complete the training procedures during which they will select an e-cigarette device to use for future preference sessions. During the 4 preference sessions, participants will sample puffs from an e-cigarette and regular cigarette and answer questions about their experience with each. They will also complete a task during which they can choose to earn puffs from the e-cigarette or regular cigarette, or choose to not take any puffs. The 4 sessions will be the same except that a different combination of e-cigarette and regular cigarette is used at each session.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Legal age to purchase tobacco products;
  • Regular user of EC and CC;
  • Owns the e-cigarette device used most often;
  • Agrees to abstain from using all tobacco products for 12 hours prior to each experimental session;
  • Self-reporting tobacco flavored e-liquid is preferred or usual flavor e-liquid

Exclusion criteria

  • Unstable medical conditions as determined by the licensed medical professional;
  • Unstable psychiatric conditions as determined by the licensed medical professional or PI;
  • Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy;
  • Serious quit attempt of either or both products in the past 3 months resulting in >30 days of abstinence;
  • Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide;
  • Plans to quit use of either EC or CC, or all tobacco products in the next 45 days;
  • Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid;
  • Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
  • Systolic blood pressure (BP) greater than or equal to 160 mm/hg
  • Diastolic BP greater than or equal to 100 mm/hg
  • Heart rate greater than or equal to 115 bpm;
  • Allergy to propylene glycol or vegetable glycerin;
  • Previous adverse reaction when using vaping device or e-liquid;
  • Current or recent alcohol or drug abuse problems;
  • Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months;
  • Literate and able to independently complete and comprehend the consent form and other written study materials and measures.

Treatment and study plan

Very low nicotine content cigarettes

Other

Investigational combusted cigarettes with very low nicotine content

Other names: VLNC

Normal Nicotine Content Cigarettes

Other

Investigational combusted cigarettes with normal nicotine content

Other names: NNC

Study e-cigarette

Other

E-cigarette provided by study

Primary outcomes

  1. Number of choices for CC during preference task

    Time frame: during preference session, approximately 2 hours

    Participants will complete a preference task during which they will choose to take puffs from the session EC, the session CC, or to abstain from taking any puffs. A total of 10 trials will be completed. The number of choices for CC will be compared across the preference sessions.

Secondary outcomes

  1. Number of choices for EC during preference task

    Time frame: during preference session, approximately 2 hours

    Participants will complete a preference task. The number of choices for EC will be compared across the preference sessions.

  2. Number of choices to abstain during preference task

    Time frame: during preference session, approximately 2 hours

    Participants will complete a preference task. The number of choices to abstain from any puffs will be compared across the preference sessions.

  3. Cigarette Evaluation Scale

    Time frame: during preference session, approximately 2 hours

    subjective reactions (e.g., satisfaction, dizziness) to CC product as well as how much a measure of how much they would pay for a day's worth of the product. Scale is administered on a 0-100 scale where 0 is "not at all" and 100 is "extremely"

  4. Perceived health risk

    Time frame: during preference session, approximately 2 hours

    Participants will rate on a scale from 1 (very low risk) to 7 (very high risk) their perceived risk of developing a variety of health conditions (e.g., lung cancer, heart disease, stroke) as a result of using each product.

  5. Craving

    Time frame: during preference session, approximately 2 hours

    craving rating on a scale from 1-10 [no urge to extremely strong urge] for CC and EC after product exposure relative to baseline value

  6. Product Valuation

    Time frame: during preference session, approximately 2 hours

    Participants will be asked how many days per month would they use the CC product they just sampled at a variety of price increments

  7. CO boost

    Time frame: during preference session, approximately 2 hours

    Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value

  8. Cross Price Elasticity

    Time frame: during preference session, approximately 2 hours

    the change in demand for the session CC in response to a change in price of the session EC

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 26, 2022
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.