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.

Study Overview

• Status: Completed
• Conditions: Smoking; Nicotine Dependence; Smoking, Cigarette; E-Cig Use
• Intervention / Treatment: Other: Study e-cigarette; Other: normal nicotine content cigarettes; Other: very low nicotine content 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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study EC + UB CC; Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC)	Other: Study e-cigarette; E-cigarette provided by study
Active Comparator: Study EC + NNC CC; Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC	Other: Study e-cigarette; E-cigarette provided by study; Other: normal nicotine content cigarettes; Investigational combusted cigarettes with normal nicotine content; Other Names: NNC
Experimental: Study EC + VLNC CC; Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC	Other: Study e-cigarette; E-cigarette provided by study; Other: very low nicotine content cigarettes; Investigational combusted cigarettes with very low nicotine content; Other Names: VLNC
No Intervention: Own EC + UB CC; Participants will make choices between their own EC device with their own tobacco flavor and their UB CC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
CO boost	Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value	during preference session, approximately 2 hours
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Francis McClernon, Ph.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Nicotine Reduction; Dual users
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Pro00105539; 5R01DA048454 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No