Electronic Cigarette UseNCT04399031
Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1
A study testing E-cigarette e-liquid in people with Electronic Cigarette Use and Cigarette Use, Electronic, run by University of Southern California at 1 site in United States.
Trial summary
This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use, Cigarette Use, Electronic, Vaping
- What is being tested?
- E-cigarette e-liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 1 Mar 2020
- 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
- Vapers/E-cigarette Users
- E-cigarette/vaping device use at least three days per week for at least 2 months
- Regular use of e-cigarettes/vaping devices containing nicotine
- Cigarette Smokers
- Daily cigarette smoking for at least two years
- Currently smoke at least four cigarettes per day
- Interested in trying an e-cigarette or current use of an e-cigarette
Who cannot join
- Vapers/E-cigarette Users
- Pregnant or breastfeeding
- Desire to cut down on use of e-cigarette/vaping device
- Cigarette Smokers
- Pregnant or breastfeeding
- Current daily use of other combustible tobacco products (such as cigars)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For this substudy, young adult vapers (N=100) and adult smokers (N=100) will attend one laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, nicotine formulation).
- Being tested
- E-cigarette e-liquid
- Medical subject headings
- Vaping, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarette e-liquidDrug
Participants will self-administer an experimenter-provided e-cigarette.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette e-liquid 1 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 2 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 3 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 4 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 5 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 6 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 7 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 8 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 9 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 10 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 11 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 12 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 13 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 14 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 15 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 16 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 17 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 18 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 19 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
| E-cigarette e-liquid 20 | Experimental | Participants will self-administer an e-cigarette e-liquid. Receives: Drug: E-cigarette e-liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Appeal
Self-report measures of product appeal will be completed following e-cigarette self-administration.
Measured: 1 hour
Sensory Appeal
Self-report measures of product appeal will be completed following e-cigarette self-administration.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Dec 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Leventhal, University of Southern California
- Investigators
- Adam M Leventhal, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399031
- Sponsor's protocol ID
- HS-18-00839 Substudy 1
- Status last verified
- Jul 2023
- First submitted
- 18 May 2020
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tackett AP, Dai HD, Han DH, Vogel EA, Coreas SI, Jafarzadeh N, Gonzalez Anaya MJ, Patel D, Peraza N, Mason TB, Leventhal AM. Appeal of e-cigarette flavors: Differences between never and ever use of combustible cigarettes. Drug Alcohol Depend. 2023 May 1;246:109849. doi: 10.1016/j.drugalcdep.2023.109849. Epub 2023 Mar 23.
PubMed 37028103Leventhal AM, Madden DR, Peraza N, Schiff SJ, Lebovitz L, Whitted L, Barrington-Trimis J, Mason TB, Anderson MK, Tackett AP. Effect of Exposure to e-Cigarettes With Salt vs Free-Base Nicotine on the Appeal and Sensory Experience of Vaping: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2032757. doi: 10.1001/jamanetworkopen.2020.32757.
PubMed 33433597
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1
- ClinicalTrials.gov ID
- NCT04399031
- Acronym / sponsor ID
- HS-18-00839 Substudy 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 22 May 2020 (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.
This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For this substudy, young adult vapers (N=100) and adult smokers (N=100) will attend one laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, nicotine formulation).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| E-cigarette e-liquid 1 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 2 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 3 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 4 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 5 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 6 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 7 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 8 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 9 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 10 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 11 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 12 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 13 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 14 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 15 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 16 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 17 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 18 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 19 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
| E-cigarette e-liquid 20 | Experimental | Drug: E-cigarette e-liquidParticipants will self-administer an e-cigarette e-liquid. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Vapers/E-cigarette Users
- E-cigarette/vaping device use at least three days per week for at least 2 months
- Regular use of e-cigarettes/vaping devices containing nicotine
- Cigarette Smokers
- Daily cigarette smoking for at least two years
Key exclusion criteria (6 listed)
- Vapers/E-cigarette Users
- Pregnant or breastfeeding
- Desire to cut down on use of e-cigarette/vaping device
- Cigarette Smokers
- Pregnant or breastfeeding
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 |
|---|---|---|
| E-cigarette e-liquidParticipants will self-administer an experimenter-provided e-cigarette. | Drug | E-cigarette e-liquid 1, E-cigarette e-liquid 10, E-cigarette e-liquid 11, E-cigarette e-liquid 12, E-cigarette e-liquid 13, E-cigarette e-liquid 14, E-cigarette e-liquid 15, E-cigarette e-liquid 16, E-cigarette e-liquid 17, E-cigarette e-liquid 18, E-cigarette e-liquid 19, E-cigarette e-liquid 2, E-cigarette e-liquid 20, E-cigarette e-liquid 3, E-cigarette e-liquid 4, E-cigarette e-liquid 5, E-cigarette e-liquid 6, E-cigarette e-liquid 7, E-cigarette e-liquid 8, E-cigarette e-liquid 9 |
Primary outcome
Subjective Appeal
Time frame: 1 hour
Self-report measures of product appeal will be completed following e-cigarette self-administration.
Sensory Appeal
Time frame: 1 hour
Self-report measures of product appeal will be completed following e-cigarette self-administration.
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 11 Jul 2023.
- Derived from this study: PubMed 37028103Tackett AP, Dai HD, Han DH, Vogel EA, Coreas SI, Jafarzadeh N, Gonzalez Anaya MJ, Patel D, Peraza N, Mason TB, Leventhal AM. Appeal of e-cigarette flavors: Differences between never and ever use of combustible cigarettes. Drug Alcohol Depend. 2023 May 1;246:109849. doi: 10.1016/j.drugalcdep.2023.109849. Epub 2023 Mar 23.
- Derived from this study: PubMed 33433597Leventhal AM, Madden DR, Peraza N, Schiff SJ, Lebovitz L, Whitted L, Barrington-Trimis J, Mason TB, Anderson MK, Tackett AP. Effect of Exposure to e-Cigarettes With Salt vs Free-Base Nicotine on the Appeal and Sensory Experience of Vaping: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2032757. doi: 10.1001/jamanetworkopen.2020.32757.
- 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.
Adam M Leventhal, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette e-liquid in people with Electronic Cigarette Use and Cigarette Use, Electronic, run by University of Southern California 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 7 inclusion and 6 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 11 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?
Subjective Appeal (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399031, which also lists 2 linked publications.
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 11 Jul 2023.