Electronic CigarettesNCT03435562
Assessment of Two New Electronic Cigarettes in Cigarette Smokers
A study testing JUUL electronic cigarette, IQOS electronic cigarette and Own Brand cigarette in people with Electronic Cigarettes, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use an two new electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of cigarettes. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarettes
- What is being tested?
- JUUL electronic cigarette, IQOS electronic cigarette and Own Brand cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2018to 16 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- healthy (determined by self-report)
- between the ages of 18-55
- willing to provide informed consent
- able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
- cigarette smokers
Who cannot join
- Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
- Individuals who weigh less than 110 pounds
- Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Behavioral Pharmacolgy Laboratory
Richmond, Virginia, 23298
About this study
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use an two new electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of cigarettes.
- Conditions
- Electronic Cigarettes
- Being tested
- JUUL electronic cigarette, IQOS electronic cigarette, Own Brand cigarette
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUUL electronic cigaretteOther
Effects of JUUL electronic cigarette use.
IQOS electronic cigaretteOther
Effects of IQOS electronic cigarette use.
Own Brand cigaretteOther
Effects of own brand cigarette use.
| Study group | Role | What they receive |
|---|---|---|
| electronic cigarette vs own brand use | Experimental | Participants will come in for three session. During one session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (the session will be approximately 3 hours). The order of the sessions will be determined randomly and data about session will not be recorded or used in the analysis. Receives: Other: JUUL electronic cigarette; Other: IQOS electronic cigarette; Other: Own Brand cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Nicotine
Change in plasma nicotine level
Measured: Blood will be taken 4 times in each session: at baseline, 5 min after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Secondary outcomes (24)
Carbon Monoxide Levels
Carbon monoxide levels (in parts per mission)
Measured: Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1
This scale is used to assess the extent to which product use reduces the intention to smoke a cigarette, and consists of 5 items that are scored 0 - 7, in which participants clicked seven discrete ratings from 'not at all' to 'extremely'. The items are summed and scores range from 0 to 30 with higher scores indicating higher craving for a cigarette.
Measured: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2
This scale is used to assess the extent to which product use reduces the intention to smoke a cigarette, and consists of 4 items that are scored 0 - 7, in which participants clicked seven discrete ratings from 'not at all' to 'extremely'. The items are summed and scores range from 0 to 24 with higher scores indicating higher craving for a cigarette.
Measured: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Anxious
This scale is used to assess the extent to which product use affects on anxiety and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Craving
This scale is used to assess the extent to which product use affects on craving a cigarette and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Depression
This scale is used to assess the extent to which product use affects on depression and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Difficulty Concentrating
This scale is used to assess the extent to which product use affects having difficulty concentrating and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Drowsy
This scale is used to assess the extent to which product use affects feeling drowsy and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Hunger
This scale is used to assess the extent to which product use affects reducing hunger and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Impatient
This scale is used to assess the extent to which product use affects feeling impatient and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Irritable
This scale is used to assess the extent to which product use affects feeling irritable and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Restless
This scale is used to assess the extent to which product use affects feeling restless and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Desire for Sweets
This scale is used to assess the extent to which product use affects having desire for sweets and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Urge to Smoke
This scale is used to assess the extent to which product use affects having the urge to smoke and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.
Measured: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Awake
One question is used to assess how much product use makes participants feel awake, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Calm
One question is used to assess how much product use makes participants feel calm, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Concentrate
One question is used to assess how much product use helps participants concentrate, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Dizzy
One question is used to assess how much product use makes participants feel dizzy, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Reduce Hunger
One question is used to assess how much product use reduces feeling of hunger, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Sick
One question is used to assess how much product use makes participants feel sick, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Product Use Questionnaire - Pleasant
A single question is used to assess if product use felt pleasant, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approxiamtely 1-hour ad lib use period.
Direct Effects of Product Use Questionnaire - Taste Good
A single question is used to assess if product use tasted good, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approxiamtely 1-hour ad lib use period.
Direct Effects of Product Use Questionnaire - Satisfying
A single question is used to assess if product use felt satisfying, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approxiamtely 1-hour ad lib use period.
Direct Effects of Product Use Questionnaire - Smoke Right Now
A single question is used to assess if product use made them want to use the product again right now, and is scored 0 (not at all) to 100 (extremely).
Measured: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approxiamtely 1-hour ad lib use period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start3 Mar 2018
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Electronic CigarettesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Breland, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435562
- Sponsor's protocol ID
- HM20012013
- Status last verified
- Jul 2020
- First submitted
- 1 Feb 2018
- Last updated
- 3 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Two New Electronic Cigarettes in Cigarette Smokers
- ClinicalTrials.gov ID
- NCT03435562
- Acronym / sponsor ID
- HM20012013
- Conditions
- Electronic Cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use an two new electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of cigarettes.
Study design
- Primary purpose
- Other
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electronic cigarette vs own brand use | Experimental | Other: JUUL electronic cigarette, Other: IQOS electronic cigarette, Other: Own Brand cigaretteParticipants will come in for three session. During one session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (the session will be approximately 3 hours). The order of the sessions will be determined randomly and data about session will not be recorded or used in the analysis. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy (determined by self-report)
- between the ages of 18-55
- willing to provide informed consent
- able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
- cigarette smokers
Key exclusion criteria (3 listed)
- Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
- Individuals who weigh less than 110 pounds
- Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
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 electronic cigaretteEffects of JUUL electronic cigarette use. | Other | electronic cigarette vs own brand use |
| IQOS electronic cigaretteEffects of IQOS electronic cigarette use. | Other | electronic cigarette vs own brand use |
| Own Brand cigaretteEffects of own brand cigarette use. | Other | electronic cigarette vs own brand use |
Primary outcome
Change in Plasma Nicotine
Time frame: Blood will be taken 4 times in each session: at baseline, 5 min after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Change in plasma nicotine level
24 secondary outcomes
Carbon Monoxide Levels
Time frame: Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Anxious
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Craving
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Depression
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Difficulty Concentrating
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Drowsy
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Hunger
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Impatient
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Irritable
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Restless
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Desire for Sweets
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Hughes-Hatsukami Questionnaire - Urge to Smoke
Time frame: Questionnaire will be administered 4 times in each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Awake
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Calm
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Concentrate
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Dizzy
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Reduce Hunger
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Nicotine Questionnaire - Sick
Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.
Direct Effects of Product Use Questionnaire - Pleasant
Time frame: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approxiamtely 1-hour ad lib use period.
Direct Effects of Product Use Questionnaire - Taste Good
Time frame: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approxiamtely 1-hour ad lib use period.
Direct Effects of Product Use Questionnaire - Satisfying
Time frame: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approxiamtely 1-hour ad lib use period.
Direct Effects of Product Use Questionnaire - Smoke Right Now
Time frame: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approxiamtely 1-hour ad lib use period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Alison Breland, PhD principal investigator
Virginia Commonwealth University
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 electronic cigarette, IQOS electronic cigarette and Own Brand cigarette in people with Electronic Cigarettes, run by Virginia Commonwealth University 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 5 inclusion and 3 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 3 Aug 2020. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Plasma Nicotine (time frame: Blood will be taken 4 times in each session: at baseline, 5 min after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.). 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 3 Aug 2020.