Substance-Related DisorderNCT04533542
Nicotine Vapor Specific Sensory Measurement
An observational study of Substance-Related Disorder, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorder
- What is being tested?
- Measurement and Questionnaire Administration
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 7 Mar 2023
- Phase
- Observational
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants from general population in the greater Buffalo area and are current daily vapers
Who may be able to join
- Current daily vapers of products containing nicotine
- No concurrent use of other tobacco products
- Self reported general good health
- No allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures
- No self-reported taste or smell deficits
- Not pregnant or lactating
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- No medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
- Passing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
- Access to video-conference or telephone
- Ability to store test products in a secure location away from children
Who cannot join
- Not current daily vapers
- Concurrent use of other tobacco products
- Self-reported fair or poor general health
- Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
- Self-reported taste or smell deficits
- Pregnant or lactating
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- Medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
- Failing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
- No access to video-conference or telephone
- Unable to store test products in a secure location away from children
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Adults unable to consent
- Adults unable to legally purchase tobacco products in New York (NY) state (18-20)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
This trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.
Read the detailed description
PRIMARY OBJECTIVE:
- Study that flavors might be related to the phenomenon of 'indirect' toxicity.
OUTLINE: Participants are randomized to 1 of 2 conditions.
CONDITION I: Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations).
CONDITION II: Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).
- Conditions
- Substance-Related Disorder
- Being tested
- Measurement, Questionnaire Administration
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementOther
Also called Measure, {Measure}
Undergo sensory measurements
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (3 video or telephone conferences) | Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations). Receives: Other: Measurement; Other: Questionnaire Administration | |
| Arm II (2 video or telephone conferences) | Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form). Receives: Other: Measurement; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory response measures
Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely
Measured: 2 years
Sensory response measure
gMLS rating of harshness, throat hit, and pleasantness.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start10 Mar 2021
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisorderStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Richard J O'Connor, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533542
- Sponsor's protocol ID
- I 471719
- Other IDs
- NCI-2019-06972, I 471719, U54CA238110
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2020
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Vapor Specific Sensory Measurement
- ClinicalTrials.gov ID
- NCT04533542
- Acronym / sponsor ID
- I 471719
- Conditions
- Substance-Related Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 31 Aug 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 trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.
Detailed description
PRIMARY OBJECTIVE:
- Study that flavors might be related to the phenomenon of 'indirect' toxicity.
OUTLINE: Participants are randomized to 1 of 2 conditions.
CONDITION I: Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations).
CONDITION II: Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (3 video or telephone conferences) | – | Other: Measurement, Other: Questionnaire AdministrationParticipants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations). |
| Arm II (2 video or telephone conferences) | – | Other: Measurement, Other: Questionnaire AdministrationParticipants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants from general population in the greater Buffalo area and are current daily vapers
Key inclusion criteria (10 listed)
- Current daily vapers of products containing nicotine
- No concurrent use of other tobacco products
- Self reported general good health
- No allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures
- No self-reported taste or smell deficits
Key exclusion criteria (15 listed)
- Not current daily vapers
- Concurrent use of other tobacco products
- Self-reported fair or poor general health
- Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
- Self-reported taste or smell deficits
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 |
|---|---|---|
| MeasurementAlso: Measure, {Measure}Undergo sensory measurements | Other | Arm I (3 video or telephone conferences), Arm II (2 video or telephone conferences) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (3 video or telephone conferences), Arm II (2 video or telephone conferences) |
Primary outcome
Sensory response measures
Time frame: 2 years
Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely
Sensory response measure
Time frame: 2 years
gMLS rating of harshness, throat hit, and pleasantness.
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 5 Apr 2024.
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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.
Richard J O'Connor principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance-Related Disorder, run by Roswell Park Cancer Institute 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 10 inclusion and 15 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 5 Apr 2024. 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?
Sensory response measures (time frame: 2 years). 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?
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 5 Apr 2024.