Back to resultsImpact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Primary Purpose
Smoking, Smoking, Cigarette, E-Cig Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
very low nicotine content cigarettes
normal nicotine content cigarettes
Study e-cigarette
Sponsored by
About this trial
This is an interventional other trial for Smoking focused on measuring Nicotine Reduction, Dual users
Eligibility Criteria
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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
No Intervention
Arm Label
Study EC + UB CC
Study EC + NNC CC
Study EC + VLNC CC
Own EC + UB CC
Arm Description
Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC)
Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC
Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC
Participants will make choices between their own EC device with their own tobacco flavor and their UB CC
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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"
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.
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
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
CO boost
Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value
Cross Price Elasticity
the change in demand for the session CC in response to a change in price of the session EC
Full Information
NCT ID
NCT05473585
First Posted
July 13, 2022
Last Updated
July 17, 2023
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05473585
Brief Title
Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Official Title
Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
May 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Smoking, Cigarette, E-Cig Use, Nicotine Dependence
Keywords
Nicotine Reduction, Dual users
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will complete 4 experimental sessions. At each session, they will receive a different combination of e-cigarette and combusted cigarette.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study EC + UB CC
Arm Type
Active Comparator
Arm Description
Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC)
Arm Title
Study EC + NNC CC
Arm Type
Active Comparator
Arm Description
Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC
Arm Title
Study EC + VLNC CC
Arm Type
Experimental
Arm Description
Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC
Arm Title
Own EC + UB CC
Arm Type
No Intervention
Arm Description
Participants will make choices between their own EC device with their own tobacco flavor and their UB CC
Intervention Type
Other
Intervention Name(s)
very low nicotine content cigarettes
Other Intervention Name(s)
VLNC
Intervention Description
Investigational combusted cigarettes with very low nicotine content
Intervention Type
Other
Intervention Name(s)
normal nicotine content cigarettes
Other Intervention Name(s)
NNC
Intervention Description
Investigational combusted cigarettes with normal nicotine content
Intervention Type
Other
Intervention Name(s)
Study e-cigarette
Intervention Description
E-cigarette provided by study
Primary Outcome Measure Information:
Title
Number of choices for CC during preference task
Description
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.
Time Frame
during preference session, approximately 2 hours
Secondary Outcome Measure Information:
Title
Number of choices for EC during preference task
Description
Participants will complete a preference task. The number of choices for EC will be compared across the preference sessions.
Time Frame
during preference session, approximately 2 hours
Title
Number of choices to abstain during preference task
Description
Participants will complete a preference task. The number of choices to abstain from any puffs will be compared across the preference sessions.
Time Frame
during preference session, approximately 2 hours
Title
Cigarette Evaluation Scale
Description
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"
Time Frame
during preference session, approximately 2 hours
Title
Perceived health risk
Description
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.
Time Frame
during preference session, approximately 2 hours
Title
Craving
Description
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
Time Frame
during preference session, approximately 2 hours
Title
Product Valuation
Description
Participants will be asked how many days per month would they use the CC product they just sampled at a variety of price increments
Time Frame
during preference session, approximately 2 hours
Title
CO boost
Description
Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value
Time Frame
during preference session, approximately 2 hours
Title
Cross Price Elasticity
Description
the change in demand for the session CC in response to a change in price of the session EC
Time Frame
during preference session, approximately 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis McClernon, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
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