E-cigarette UseNCT05949034
Effects of E-Cigarettes in Menthol Smokers
A study testing JUUL E-Cigarette Device in people with E-cigarette Use and Smoking Behaviors, run by University of Southern California at 1 site in United States.
Trial summary
The current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- E-cigarette Use, Smoking Behaviors
- What is being tested?
- JUUL E-Cigarette Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 14 Nov 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
- Daily cigarette smoking for at least the past 2 years
- Interest in trying e-cigarettes
- Report smoking mentholated cigarettes
Who cannot join
- -- Pregnancy and/or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
The current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers.
- Conditions
- E-cigarette Use, Smoking Behaviors
- Being tested
- JUUL E-Cigarette Device
- Keywords
- menthol, cigarette, smoking
- Medical subject headings
- Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUUL E-Cigarette DeviceDevice
We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.
| Study group | Role | What they receive |
|---|---|---|
| E-Cigarette Flavor 1 Condition | Experimental | Participants will self-administer a flavored e-cigarette. Receives: Device: JUUL E-Cigarette Device |
| E-Cigarette Flavor 2 Condition | Experimental | Participants will self-administer a flavored e-cigarette. Receives: Device: JUUL E-Cigarette Device |
| E-Cigarette Flavor 3 Condition | Experimental | Participants will self-administer a flavored e-cigarette. Receives: Device: JUUL E-Cigarette Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference Ratings
Self-report measures of product preference will be completed following the e-cigarette self-administration. Scores can range from 0 to 100 for the preference rating, with lower scores representing less preference and higher scores representing higher preference.
Measured: 1 hour
Mood - Positive Affect Negative Affect Schedule
This measure is obtained through the completion of the Positive Affect Negative Affect Schedule. A total score will be calculated for both Positive and Negative Affect. Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
Measured: 4 hours
Mood - Profile of Mood States
This measure is obtained through the completion of the Profile of Mood States. A total score will be calculated. Scores can range from 10 to 260, with the lower scores representing lower levels of mood disturbance and higher scores representing higher levels of mood disturbance.
Measured: 4 hours
Cigarette Craving
This measure is obtained through the completion of the Brief Questionnaire of Smoking Urges. A total score will be calculated. Scores can range from 10 to 70, with the lower scores representing a lower level of cigarette craving and higher scores representing greater levels of cigarette craving.
Measured: 4 hours
Nicotine Withdrawal - Minnesota Nicotine Withdrawal Scale
This measure is obtained through the completion of the Minnesota Nicotine Withdrawal Scale. A total score will be calculated. Scores can range from 0 to 32, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal.
Measured: 4 hours
Nicotine Withdrawal - Wisconsin Smoking Withdrawal Scale
This measure is obtained through the completion of the Wisconsin Smoking Withdrawal Scale. A total score will be calculated. Scores can range from 0 to 112, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal.
Measured: 4 hours
Smoking Motivation
This measure is obtained through the completion of a computerized behavioral task.
Measured: 2 hours after experimental session outset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Jul 2019
- Primary completion14 Nov 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigarette UseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 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 Leventhal, Ph.D., Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949034
- Sponsor's protocol ID
- HS-19-00325
- Status last verified
- Jul 2023
- First submitted
- 29 May 2019
- Last updated
- 20 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of E-Cigarettes in Menthol Smokers
- ClinicalTrials.gov ID
- NCT05949034
- Acronym / sponsor ID
- HS-19-00325
- Conditions
- E-cigarette Use, Smoking Behaviors
- Keywords
- menthol, cigarette, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 17 Jul 2023 (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 current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E-Cigarette Flavor 1 Condition | Experimental | Device: JUUL E-Cigarette DeviceParticipants will self-administer a flavored e-cigarette. |
| E-Cigarette Flavor 2 Condition | Experimental | Device: JUUL E-Cigarette DeviceParticipants will self-administer a flavored e-cigarette. |
| E-Cigarette Flavor 3 Condition | Experimental | Device: JUUL E-Cigarette DeviceParticipants will self-administer a flavored e-cigarette. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Daily cigarette smoking for at least the past 2 years
- Interest in trying e-cigarettes
- Report smoking mentholated cigarettes
Key exclusion criteria (1 listed)
- -- Pregnancy and/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 |
|---|---|---|
| JUUL E-Cigarette DeviceWe will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions. | Device | E-Cigarette Flavor 1 Condition, E-Cigarette Flavor 2 Condition, E-Cigarette Flavor 3 Condition |
Primary outcome
Preference Ratings
Time frame: 1 hour
Self-report measures of product preference will be completed following the e-cigarette self-administration. Scores can range from 0 to 100 for the preference rating, with lower scores representing less preference and higher scores representing higher preference.
Mood - Positive Affect Negative Affect Schedule
Time frame: 4 hours
This measure is obtained through the completion of the Positive Affect Negative Affect Schedule. A total score will be calculated for both Positive and Negative Affect. Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
Mood - Profile of Mood States
Time frame: 4 hours
This measure is obtained through the completion of the Profile of Mood States. A total score will be calculated. Scores can range from 10 to 260, with the lower scores representing lower levels of mood disturbance and higher scores representing higher levels of mood disturbance.
Cigarette Craving
Time frame: 4 hours
This measure is obtained through the completion of the Brief Questionnaire of Smoking Urges. A total score will be calculated. Scores can range from 10 to 70, with the lower scores representing a lower level of cigarette craving and higher scores representing greater levels of cigarette craving.
Nicotine Withdrawal - Minnesota Nicotine Withdrawal Scale
Time frame: 4 hours
This measure is obtained through the completion of the Minnesota Nicotine Withdrawal Scale. A total score will be calculated. Scores can range from 0 to 32, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal.
Nicotine Withdrawal - Wisconsin Smoking Withdrawal Scale
Time frame: 4 hours
This measure is obtained through the completion of the Wisconsin Smoking Withdrawal Scale. A total score will be calculated. Scores can range from 0 to 112, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal.
Smoking Motivation
Time frame: 2 hours after experimental session outset
This measure is obtained through the completion of a computerized behavioral task.
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 20 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.
Adam Leventhal, Ph.D. study chair
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 JUUL E-Cigarette Device in people with E-cigarette Use and Smoking Behaviors, 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 3 inclusion and 1 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 20 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?
Preference Ratings (time frame: 1 hour). The study lists 7 primary outcomes in all. 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 20 Jul 2023.