Cigarette SmokerENDSNCT02575885
Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers
A study testing Electronic Cigarette, Laboratory Biomarker Analysis and Pharmacological Study in people with Cigarette Smoker and Current Smoker, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from conventional cigarettes (the participant's own… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Current Smoker, Healthy Subject
- What is being tested?
- Electronic Cigarette, Laboratory Biomarker Analysis and Pharmacological Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2016to 6 Jun 2018
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of medical history
- Current moderate-to-heavy smoker as determined by:
- Has smoked >=10 cigarettes per day regularly for the past year (by history) and (>=5 cigarettes per day Study 2 ONLY)
- Has an expired carbon monoxide (CO) at screening visit of 8 parts per million (ppm) or more (6 ppm or more Study 2 ONLY)
- Nicotine dependence assessed as > 4 with the Fagerstrom Test for Nicotine Dependence
- Willingness to abstain from smoking for 8 hours (overnight abstinence) prior to study visits
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants
- Pregnancy or lactation (by history) or positive pregnancy test at screening visit
- Positive urine drug test at screening visit
- History of serious side effects from nicotine or from any nicotine replacement therapies
- Alcohol or illicit drug dependence within the past 12 months (by history and urine tests)
- Concurrent participation in another clinical trial
Show all 9Show fewer
- Unable to communicate in English
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Nicotine Delivery From Novel Non-tobacco Electronic Systems (ENDS)
This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from conventional cigarettes (the participant's own brand) may help provide information about the use of nicotine-containing products that may help inform/reform current tobacco policy, practice, and harm reduction approaches.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes. (Study 1)
II. Explore the effect of flavorings added to nicotine solution on puffing topography and nicotine delivery and, assess and compare short-term "functional" nicotine effects of the different products by using subjective measures such as relief of craving and withdrawal symptoms. (Study 2)
SECONDARY OBJECTIVES:
- Determine the amounts of nicotine present in various brands and types of ENDS. (Study 3)
II. Determine nicotine yields in vapors from various types of ENDS under laboratory conditions. (Study 4)
TERTIARY OBJECTIVES:
- Develop a standardized testing protocol for ENDS that will reflect users' puffing behavior and product characteristics.
II. Develop and validate the analytical method for analysis of nicotine content in the vapor.
III. Propose a standardized puffing regimen for generating vapors for analytical purposes: Such a testing protocol will reflect the puffing behavior observed among ENDS users and should be specific to ENDS type.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (Study 1): Participants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
ARM II (Study 2): Participants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
- Conditions
- Cigarette Smoker, Current Smoker, Healthy Subject
- Being tested
- Electronic Cigarette, Laboratory Biomarker Analysis, Pharmacological Study, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic CigaretteOther
Also called e-Cigarette, Electronic Nicotine Delivery System
Receive different type of ENDS product at each visit
Electronic CigaretteOther
Also called e-Cigarette, Electronic Nicotine Delivery System
Receive BLU e-cigarette ENDS product
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (different type of ENDS product at each visit) | Experimental | Participants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit. Receives: Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Questionnaire Administration |
| Arm II (BLU e-cigarette ENDS product with different flavors) | Experimental | Participants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit. Receives: Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
The maximum concentration of nicotine in plasma (Cmax) will be determined for each product.
Measured: Up to 1 year
Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
Time to maximum concentration (Tmax) will be determined for each product .
Measured: Up to 1 year
Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
Area under the plasma concentration versus time curve (AUC) will be determined for each product.
Measured: up to 1 year
Changes in withdrawal symptoms
Will be measured with Minnesota Withdrawal Scale
Measured: up to 1 year
Subjective nicotine effect will be analyzed
Will be measured with Drug Effect Questionnaire
Measured: up to 1 year
Changes in feelings and emotions
Will be measured with The Positive Negative Affect Scale
Measured: up to 1 year
Secondary outcomes (2)
Amounts of nicotine present in various brands and types of ENDS (Study 3)
Nicotine content (mean, median, minimum and maximum) will be determined for each product
Measured: Up to 1 year
Nicotine yields in vapors from various types of ENDS under laboratory conditions (Study 4)
Nicotine yield in vapor will be determined for each product.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start16 Mar 2016
- Primary completion6 Jun 2018
- Study completion6 Jun 2018
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 Cigarette SmokerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Martin Mahoney, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575885
- Sponsor's protocol ID
- I 257514
- Other IDs
- NCI-2015-01187, I 257514, P30CA016056, R01DA037446
- Acronym
- ENDS
- Status last verified
- Jun 2018
- First submitted
- 6 Aug 2015
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Voos N, Smith D, Kaiser L, Mahoney MC, Bradizza CM, Kozlowski LT, Benowitz NL, O'Connor RJ, Goniewicz ML. Effect of e-cigarette flavors on nicotine delivery and puffing topography: results from a randomized clinical trial of daily smokers. Psychopharmacology (Berl). 2020 Feb;237(2):491-502. doi: 10.1007/s00213-019-05386-x. Epub 2019 Nov 26.
PubMed 31773209
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Delivery From Novel Non-tobacco Electronic Systems (ENDS)
- ClinicalTrials.gov ID
- NCT02575885
- Acronym / sponsor ID
- ENDS / I 257514
- Conditions
- Cigarette Smoker, Current Smoker, Healthy Subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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 randomized pilot clinical trial studies nicotine delivery from novel non-tobacco electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from conventional cigarettes (the participant's own brand) may help provide information about the use of nicotine-containing products that may help inform/reform current tobacco policy, practice, and harm reduction approaches.
Detailed description
PRIMARY OBJECTIVES:
- Determine the levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes. (Study 1)
II. Explore the effect of flavorings added to nicotine solution on puffing topography and nicotine delivery and, assess and compare short-term "functional" nicotine effects of the different products by using subjective measures such as relief of craving and withdrawal symptoms. (Study 2)
SECONDARY OBJECTIVES:
- Determine the amounts of nicotine present in various brands and types of ENDS. (Study 3)
II. Determine nicotine yields in vapors from various types of ENDS under laboratory conditions. (Study 4)
TERTIARY OBJECTIVES:
- Develop a standardized testing protocol for ENDS that will reflect users' puffing behavior and product characteristics.
II. Develop and validate the analytical method for analysis of nicotine content in the vapor.
III. Propose a standardized puffing regimen for generating vapors for analytical purposes: Such a testing protocol will reflect the puffing behavior observed among ENDS users and should be specific to ENDS type.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (Study 1): Participants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
ARM II (Study 2): Participants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (different type of ENDS product at each visit) | Experimental | Other: Electronic Cigarette, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: Questionnaire AdministrationParticipants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit. |
| Arm II (BLU e-cigarette ENDS product with different flavors) | Experimental | Other: Electronic Cigarette, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: Questionnaire AdministrationParticipants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy on the basis of medical history
- Current moderate-to-heavy smoker as determined by:
- Nicotine dependence assessed as > 4 with the Fagerstrom Test for Nicotine Dependence
- Willingness to abstain from smoking for 8 hours (overnight abstinence) prior to study visits
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Key exclusion criteria (9 listed)
- Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants
- Pregnancy or lactation (by history) or positive pregnancy test at screening visit
- Positive urine drug test at screening visit
- History of serious side effects from nicotine or from any nicotine replacement therapies
- Alcohol or illicit drug dependence within the past 12 months (by history and urine tests)
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 |
|---|---|---|
| Electronic CigaretteAlso: e-Cigarette, Electronic Nicotine Delivery SystemReceive different type of ENDS product at each visit | Other | Arm I (different type of ENDS product at each visit) |
| Electronic CigaretteAlso: e-Cigarette, Electronic Nicotine Delivery SystemReceive BLU e-cigarette ENDS product | Other | Arm II (BLU e-cigarette ENDS product with different flavors) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (different type of ENDS product at each visit), Arm II (BLU e-cigarette ENDS product with different flavors) |
| Pharmacological StudyCorrelative studies | Other | Arm I (different type of ENDS product at each visit), Arm II (BLU e-cigarette ENDS product with different flavors) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (different type of ENDS product at each visit), Arm II (BLU e-cigarette ENDS product with different flavors) |
Primary outcome
Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
Time frame: Up to 1 year
The maximum concentration of nicotine in plasma (Cmax) will be determined for each product.
Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
Time frame: Up to 1 year
Time to maximum concentration (Tmax) will be determined for each product .
Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
Time frame: up to 1 year
Area under the plasma concentration versus time curve (AUC) will be determined for each product.
Changes in withdrawal symptoms
Time frame: up to 1 year
Will be measured with Minnesota Withdrawal Scale
Subjective nicotine effect will be analyzed
Time frame: up to 1 year
Will be measured with Drug Effect Questionnaire
Changes in feelings and emotions
Time frame: up to 1 year
Will be measured with The Positive Negative Affect Scale
2 secondary outcomes
Amounts of nicotine present in various brands and types of ENDS (Study 3)
Time frame: Up to 1 year
Nicotine yields in vapors from various types of ENDS under laboratory conditions (Study 4)
Time frame: Up to 1 year
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 12 Jun 2018.
- Derived from this study: PubMed 31773209Voos N, Smith D, Kaiser L, Mahoney MC, Bradizza CM, Kozlowski LT, Benowitz NL, O'Connor RJ, Goniewicz ML. Effect of e-cigarette flavors on nicotine delivery and puffing topography: results from a randomized clinical trial of daily smokers. Psychopharmacology (Berl). 2020 Feb;237(2):491-502. doi: 10.1007/s00213-019-05386-x. Epub 2019 Nov 26.
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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.
Martin Mahoney 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?
A study testing Electronic Cigarette, Laboratory Biomarker Analysis and Pharmacological Study in people with Cigarette Smoker and Current Smoker, 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 7 inclusion and 9 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 12 Jun 2018. 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?
Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (time frame: Up to 1 year). The study lists 6 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 NCT02575885, 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 12 Jun 2018.