Tobacco UseNCT03186911
The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers
A study testing E-liquid sampling and preference assessment in people with Tobacco Use, run by Wake Forest University Health Sciences.
Trial summary
Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- E-liquid sampling and preference assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Sep 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Daily cigarette smoking
- Have tried vaping devices on a minimum of one lifetime occasion
Who cannot join
- Unwilling to use a vaping device during the session
- Break alcohol level > 0.01 (g/dL)
- Pregnant, trying to become pregnant, or breastfeeding
- Systolic BP greater than or equal to 160 mm/Hg or below 90 mm/Hg
- Diastolic BP greater than or equal to 100 mm/Hg or below 50 mm/Hg
- Heart rate greater than or equal to 105 bpm or lower than 45 bpm
- A current upper respiratory infection, recent cardiac event (in the last year), Buerger disease, irregular heartbeat or arrhythmia within the last year, previous allergic or adverse reaction to nicotine
About this study
Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Participants will then sample two e-liquids that vary in nicotine content from little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the subjective effects of each one. Participants will then complete a preference assessment where they choose between the two e-liquids. Participants will be blind to the nicotine contents.
- Conditions
- Tobacco Use
- Being tested
- E-liquid sampling and preference assessment
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-liquid sampling and preference assessmentBehavioural
Participants will sample two different e-liquids that vary in nicotine content, complete questionnaires about each one, and then choose between the two e-liquids in a preference assessment task.
| Study group | Role | What they receive |
|---|---|---|
| E-liquid Group | Other | Participants will sample two different e-liquids. Receives: Behavioral: E-liquid sampling and preference assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Evaluation Questionnaire
Ratings of the two e-liquids on a self-report questionnaire
Measured: One Day
Secondary outcomes (3)
Preference Assessment
Choices of each of the two e-liquids on a preference assessment
Measured: One Day
Perceived Health Risk Questionnaire
Personal Health Risk Ratings about each of the two e-liquids
Measured: One Day
Vaping Purchase Task
Hypothetical estimates of consumption of each of the e-liquids across a variety of prices
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startJul 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Study team decided not to move forward with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Eric C Donny, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186911
- Sponsor's protocol ID
- U54 DA031659-06 Pilot
- Other IDs
- 1U54DA031659-01
- Status last verified
- Oct 2018
- First submitted
- 8 Jun 2017
- Last updated
- 5 Aug 2019
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers
- ClinicalTrials.gov ID
- NCT03186911
- Acronym / sponsor ID
- U54 DA031659-06 Pilot
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study team decided not to move forward with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 14 Jun 2017 (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.
Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Participants will then sample two e-liquids that vary in nicotine content from little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the subjective effects of each one. Participants will then complete a preference assessment where they choose between the two e-liquids. Participants will be blind to the nicotine contents.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-liquid Group | Other | Behavioral: E-liquid sampling and preference assessmentParticipants will sample two different e-liquids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Daily cigarette smoking
- Have tried vaping devices on a minimum of one lifetime occasion
Key exclusion criteria (7 listed)
- Unwilling to use a vaping device during the session
- Break alcohol level > 0.01 (g/dL)
- Pregnant, trying to become pregnant, or breastfeeding
- Systolic BP greater than or equal to 160 mm/Hg or below 90 mm/Hg
- Diastolic BP greater than or equal to 100 mm/Hg or below 50 mm/Hg
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-liquid sampling and preference assessmentParticipants will sample two different e-liquids that vary in nicotine content, complete questionnaires about each one, and then choose between the two e-liquids in a preference assessment task. | Behavioural | E-liquid Group |
Primary outcome
Product Evaluation Questionnaire
Time frame: One Day
Ratings of the two e-liquids on a self-report questionnaire
3 secondary outcomes
Preference Assessment
Time frame: One Day
Perceived Health Risk Questionnaire
Time frame: One Day
Vaping Purchase Task
Time frame: One Day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- 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.
Eric C Donny, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing E-liquid sampling and preference assessment in people with Tobacco Use, run by Wake Forest University Health Sciences.
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 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: withdrawn, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Product Evaluation Questionnaire (time frame: One Day). 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 Aug 2019.