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

Not Applicable

Completed

• Conditions: Smoking, Cigarette; Nicotine Dependence; Smoking; E-Cig Use
• Interventions: Other: very low nicotine content cigarettes; Other: normal nicotine content cigarettes; Other: Study e-cigarette

• Registration Number: NCT05473585
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-26
• Study Start: 2022-10-12
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

1. Unstable medical conditions as determined by the licensed medical professional;

2. Unstable psychiatric conditions as determined by the licensed medical professional or PI;

3. Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy;

4. Serious quit attempt of either or both products in the past 3 months resulting in >30 days of abstinence;

5. Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide;

6. Plans to quit use of either EC or CC, or all tobacco products in the next 45 days;

7. Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid;

8. Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):

   1. Systolic blood pressure (BP) greater than or equal to 160 mm/hg
   2. Diastolic BP greater than or equal to 100 mm/hg
   3. Heart rate greater than or equal to 115 bpm;

9. Allergy to propylene glycol or vegetable glycerin;

10. Previous adverse reaction when using vaping device or e-liquid;

11. Current or recent alcohol or drug abuse problems;

12. Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months;

13. Literate and able to independently complete and comprehend the consent form and other written study materials and measures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study EC + NNC CC	Study e-cigarette	Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC
Study EC + VLNC CC	very low nicotine content cigarettes	Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC
Study EC + NNC CC	normal nicotine content cigarettes	Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC
Study EC + UB CC	Study e-cigarette	Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC)
Study EC + VLNC CC	Study e-cigarette	Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC

Primary Outcome Measures

Name	Time	Method
Number of choices for CC during preference task	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 Outcome Measures

Name	Time	Method
Perceived health risk	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.
Craving	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
Number of choices to abstain during preference task	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.
Cigarette Evaluation Scale	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"
Product Valuation	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
Number of choices for EC during preference task	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.
CO boost	during preference session, approximately 2 hours	Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value
Cross Price Elasticity	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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States