Electronic CigarettesNCT03742817
Effects of e-Cigarettes on Perceptions and Behavior
A study testing e-Cigarette in people with Electronic Cigarettes, 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 Cigarettes
- What is being tested?
- e-Cigarette
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 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 use >3 day/week for >2 months
- Report regularly using e-cigarette products with nicotine
- Positive cotinine test via NicAlert test strip
- Smokers
- Daily cigarette smoking for ≥ 2 years
- Currently smoke > 4 cig/day
- Interest in trying an e-cigarette or current use of e-cigarettes
Who cannot join
- Vapers
- Pregnancy/breastfeeding
- Desire to immediately reduce e-cigarette use
- Smokers
- Breath CO < 9ppm at intake
- Pregnancy / breastfeeding
- Current daily use of other combustible tobacco products (e.g., 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 across young adult e-cigarette users and middle-age/older adult smokers with an interest in, but no significant experience with, e-cigarettes; (2) Determine which dimensions of e-cigarette product diversity differentially affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers with an interest in, but no significant experience with, e-cigarettes; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For Aim 1, young adult vapers (N=200) and adult smokers (N=200) 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, pg/vg ratio). For Aim 2, young adults vapers (N=360) and adult smokers (N=360) will administer an e-cigarette product and complete behavioral economic tasks that test the participant's choice of earning money to delay initiation and continued use of: (1) The sampled e-cigarette product (abuse liability; young adult vapers); or (2) Their own brand cigarettes (ability to resist smoking; adult current smokers). A pilot study will establish device and e-liquid parameters (e.g., nicotine concentration) to be used for all aims.
- Conditions
- Electronic Cigarettes
- Being tested
- e-Cigarette
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-CigaretteOther
Participants will self-administer an experimenter-provided e-cigarette.
| Study group | Role | What they receive |
|---|---|---|
| Sweet-Flavor 4.5% Nicotine (Salt) | Experimental | Participants will self-administer a sweet-flavored e-cigarette containing 4.5% nicotine by volume. Receives: Other: e-Cigarette |
| Sweet-Flavor 0 mg/mL Nicotine (Free-Base) | Placebo comparator | Participants will self-administer a sweet-flavored e-cigarette containing 0 mg/mL nicotine. Receives: Other: e-Cigarette |
| Sweet-Flavor 6 mg/mL Nicotine (Free-Base) | Experimental | Participants will self-administer a sweet-flavored e-cigarette containing 6 mg/mL nicotine. Receives: Other: e-Cigarette |
| Usual e-Cigarette | Active comparator | Participants will self-administer either their preferred brand combustible cigarette or e-cigarette with usual nicotine nicotine concentration. Receives: Other: e-Cigarette |
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 the e-cigarette administration.
Measured: 1 hour
Positive Affect Negative Affect Schedule
The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.
Measured: 4 hours
Questionnaire of Vaping Urges
10-item Brief Questionnaire of Vaping Urges will assess desire, intention, urge and need to vape e-cigarettes.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Feb 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 (1)Papers the sponsor has linked to this study.
- Other trials for Electronic CigarettesStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 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
- NCT03742817
- Sponsor's protocol ID
- HS-18-00839 - Pilot Study
- Status last verified
- Jul 2023
- First submitted
- 14 Nov 2018
- 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
Han DH, Wong M, Peraza N, Vogel EA, Cahn R, Mason TB, Kirkpatrick M, Tackett AP, Leventhal AM. Dose-response effects of two nicotine salt formulations on electronic cigarette appeal and sensory attributes. Tob Control. 2023 Jan 2:tobaccocontrol-2022-057553. doi: 10.1136/tc-2022-057553. Online ahead of print.
PubMed 36593119
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
- ClinicalTrials.gov ID
- NCT03742817
- Acronym / sponsor ID
- HS-18-00839 - Pilot Study
- Conditions
- Electronic Cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 Nov 2018 (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 across young adult e-cigarette users and middle-age/older adult smokers with an interest in, but no significant experience with, e-cigarettes; (2) Determine which dimensions of e-cigarette product diversity differentially affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers with an interest in, but no significant experience with, e-cigarettes; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For Aim 1, young adult vapers (N=200) and adult smokers (N=200) 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, pg/vg ratio). For Aim 2, young adults vapers (N=360) and adult smokers (N=360) will administer an e-cigarette product and complete behavioral economic tasks that test the participant's choice of earning money to delay initiation and continued use of: (1) The sampled e-cigarette product (abuse liability; young adult vapers); or (2) Their own brand cigarettes (ability to resist smoking; adult current smokers). A pilot study will establish device and e-liquid parameters (e.g., nicotine concentration) to be used for all aims.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sweet-Flavor 4.5% Nicotine (Salt) | Experimental | Other: e-CigaretteParticipants will self-administer a sweet-flavored e-cigarette containing 4.5% nicotine by volume. |
| Sweet-Flavor 0 mg/mL Nicotine (Free-Base) | Placebo comparator | Other: e-CigaretteParticipants will self-administer a sweet-flavored e-cigarette containing 0 mg/mL nicotine. |
| Sweet-Flavor 6 mg/mL Nicotine (Free-Base) | Experimental | Other: e-CigaretteParticipants will self-administer a sweet-flavored e-cigarette containing 6 mg/mL nicotine. |
| Usual e-Cigarette | Active comparator | Other: e-CigaretteParticipants will self-administer either their preferred brand combustible cigarette or e-cigarette with usual nicotine nicotine concentration. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Vapers
- E-cigarette use >3 day/week for >2 months
- Report regularly using e-cigarette products with nicotine
- Positive cotinine test via NicAlert test strip
- Smokers
Key exclusion criteria (7 listed)
- Vapers
- Pregnancy/breastfeeding
- Desire to immediately reduce e-cigarette use
- Smokers
- Breath CO < 9ppm at intake
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-CigaretteParticipants will self-administer an experimenter-provided e-cigarette. | Other | Sweet-Flavor 0 mg/mL Nicotine (Free-Base), Sweet-Flavor 4.5% Nicotine (Salt), Sweet-Flavor 6 mg/mL Nicotine (Free-Base), Usual e-Cigarette |
Primary outcome
Subjective Appeal
Time frame: 1 hour
Self-report measures of product appeal will be completed following the e-cigarette administration.
Positive Affect Negative Affect Schedule
Time frame: 4 hours
The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.
Questionnaire of Vaping Urges
Time frame: 4 hours
10-item Brief Questionnaire of Vaping Urges will assess desire, intention, urge and need to vape e-cigarettes.
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 36593119Han DH, Wong M, Peraza N, Vogel EA, Cahn R, Mason TB, Kirkpatrick M, Tackett AP, Leventhal AM. Dose-response effects of two nicotine salt formulations on electronic cigarette appeal and sensory attributes. Tob Control. 2023 Jan 2:tobaccocontrol-2022-057553. doi: 10.1136/tc-2022-057553. Online ahead of print.
- 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 in people with Electronic Cigarettes, 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 8 inclusion and 7 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. Some participants in this study may receive a placebo. 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 3 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 NCT03742817, which also lists 1 linked publication.
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.