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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05473585
• Other study ID #: Pro00105539
• Secondary ID: 5R01DA048454
• Status: Completed
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: May 9, 2023

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• E-Cig Use
• Nicotine Dependence
• Smoking
• Smoking, Cigarette
• Tobacco Use Disorder

Intervention

Other:
• very low nicotine content cigarettes
Investigational combusted cigarettes with very low nicotine content
• normal nicotine content cigarettes
Investigational combusted cigarettes with normal nicotine content
• Study e-cigarette
E-cigarette provided by study

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of choices for CC during preference task	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.	during preference session, approximately 2 hours
Secondary	Number of choices for EC during preference task	Participants will complete a preference task. The number of choices for EC will be compared across the preference sessions.	during preference session, approximately 2 hours
Secondary	Number of choices to abstain during preference task	Participants will complete a preference task. The number of choices to abstain from any puffs will be compared across the preference sessions.	during preference session, approximately 2 hours
Secondary	Cigarette Evaluation Scale	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"	during preference session, approximately 2 hours
Secondary	Perceived health risk	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.	during preference session, approximately 2 hours
Secondary	Craving	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	during preference session, approximately 2 hours
Secondary	Product Valuation	Participants will be asked how many days per month would they use the CC product they just sampled at a variety of price increments	during preference session, approximately 2 hours
Secondary	CO boost	Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value	during preference session, approximately 2 hours
Secondary	Cross Price Elasticity	the change in demand for the session CC in response to a change in price of the session EC	during preference session, approximately 2 hours