SmokingNCT05473585
Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
A study testing very low nicotine content cigarettes, normal nicotine content cigarettes and Study e-cigarette in people with Smoking and Smoking, Cigarette, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking, Cigarette, E-Cig Use
- What is being tested?
- very low nicotine content cigarettes, normal nicotine content cigarettes and Study e-cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 9 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Smoking, Smoking, Cigarette, E-Cig Use, Nicotine Dependence
- Being tested
- very low nicotine content cigarettes, normal nicotine content cigarettes, Study e-cigarette
- Keywords
- Nicotine Reduction, Dual users
- Medical subject headings
- Smoking, Cigarette Smoking, Vaping, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
very low nicotine content cigarettesOther
Also called VLNC
Investigational combusted cigarettes with very low nicotine content
normal nicotine content cigarettesOther
Also called NNC
Investigational combusted cigarettes with normal nicotine content
Study e-cigaretteOther
E-cigarette provided by study
| Study group | Role | What they receive |
|---|---|---|
| Study EC + UB CC | Active comparator | Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC) Receives: Other: Study e-cigarette |
| Study EC + NNC CC | Active comparator | Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC Receives: Other: normal nicotine content cigarettes; Other: Study e-cigarette |
| Study EC + VLNC CC | Experimental | Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC Receives: Other: very low nicotine content cigarettes; Other: Study e-cigarette |
| Own EC + UB CC | No intervention | Participants will make choices between their own EC device with their own tobacco flavor and their UB CC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during preference session, approximately 2 hours
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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"
Measured: 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.
Measured: 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
Measured: 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
Measured: during preference session, approximately 2 hours
CO boost
Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value
Measured: 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
Measured: during preference session, approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start12 Oct 2022
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Francis McClernon, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473585
- Sponsor's protocol ID
- Pro00105539
- Other IDs
- 5R01DA048454
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of New Standards for Tobacco Products Among Dual E-Cigarette/Combusted Cigarette Users - Project 2
- ClinicalTrials.gov ID
- NCT05473585
- Acronym / sponsor ID
- Pro00105539
- Conditions
- Smoking, Smoking, Cigarette, E-Cig Use, Nicotine Dependence
- Keywords
- Nicotine Reduction, Dual users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will complete 4 experimental sessions. At each session, they will receive a different combination of e-cigarette and combusted cigarette.
| Arm | Type | Receives |
|---|---|---|
| Study EC + UB CC | Active comparator | Other: Study e-cigaretteParticipants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC) |
| Study EC + NNC CC | Active comparator | Other: normal nicotine content cigarettes, Other: Study e-cigaretteParticipants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC |
| Study EC + VLNC CC | Experimental | Other: very low nicotine content cigarettes, Other: Study e-cigaretteParticipants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC |
| Own EC + UB CC | No intervention | –Participants will make choices between their own EC device with their own tobacco flavor and their UB CC |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| very low nicotine content cigarettesAlso: VLNCInvestigational combusted cigarettes with very low nicotine content | Other | Study EC + VLNC CC |
| normal nicotine content cigarettesAlso: NNCInvestigational combusted cigarettes with normal nicotine content | Other | Study EC + NNC CC |
| Study e-cigaretteE-cigarette provided by study | Other | Study EC + NNC CC, Study EC + UB CC, Study EC + VLNC CC |
Primary outcome
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.
8 secondary outcomes
Number of choices for EC during preference task
Time frame: during preference session, approximately 2 hours
Number of choices to abstain during preference task
Time frame: during preference session, approximately 2 hours
Cigarette Evaluation Scale
Time frame: during preference session, approximately 2 hours
Perceived health risk
Time frame: during preference session, approximately 2 hours
Craving
Time frame: during preference session, approximately 2 hours
Product Valuation
Time frame: during preference session, approximately 2 hours
CO boost
Time frame: during preference session, approximately 2 hours
Cross Price Elasticity
Time frame: during preference session, approximately 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis McClernon, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing very low nicotine content cigarettes, normal nicotine content cigarettes and Study e-cigarette in people with Smoking and Smoking, Cigarette, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of choices for CC during preference task (time frame: during preference session, approximately 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.