Nicotine DependenceNCT01898169
Evaluation of Short-term Safety and Use Patterns of an Electronic Nicotine Delivery System
A study testing NJOY King 26 mg nicotine Electronic Nicotine Delivery System in people with Nicotine Dependence, run by LA Clinical Trials at 1 site in United States.
Trial summary
Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes have gained in popularity over the last several years. The technology used to manufacture ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content, e-liquids and flavorings. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- NJOY King 26 mg nicotine Electronic Nicotine Delivery System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy cigarette smokers
- Not trying or planning to quit
- >10 factory-produced cigarettes/day for previous year
- Breath carbon monoxide level of >10 ppm at screening
Who cannot join
- Pregnancy or lactation
- Abuse of drugs other than tobacco
- Use of any prescription psychoactive medications within 14 days
- Use of ENDS within 14 days
- Use of any nicotine replacement within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Plasma Nicotine, Carbon Monoxide, Heart Rate, Craving and Withdrawal After Acute Use of the NJOY King E-Cigarette in the Clinic, Following a One-Week Actual Use Pilot Study
Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes have gained in popularity over the last several years. The technology used to manufacture ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content, e-liquids and flavorings. Only in the last few years have researchers begun to examine the health risks and benefits, nicotine blood levels, patterns of use, likability, and craving and withdrawal relief of ENDS. These studies have shown great variability in nicotine delivery, effects on heart rate, and relief of craving or withdrawal among various ENDS brands among tobacco cigarette smokers.
This study will test a new generation ENDS, the NJOY King Bold (NJOY, Scottsdale, AZ). It is a single use unit that resembles a traditional cigarette and delivers approximately 150 puffs. The cartridge inside contains 26 milligrams of nicotine.
Read more
Our primary objective is to evaluate the short-term effects of using the NJOY Kings ENDS on heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes and nicotine withdrawal. Our secondary objective is to evaluate the subject's usage patterns for cigarettes and NJOY King ENDS during a one-week period in which they can use each freely.
The study includes three visits to the clinic spaced approximately one week apart. Subjects who pass the screening visit will return to the clinic for Visit 2 in which they will sample the NJOY King ENDS for about 20 minutes before taking home enough to last till Visit 3, one week later. They will be instructed to use as many or as few as they like during the week. Subjects will keep a daily diary of number of tobacco cigarettes smoked and number of e-cigarette puffs taken. Subjects will return to the clinic for Visit 3 after 12 hours of abstinence from any form of nicotine in order to assure that they have no nicotine left in their bloodstream. Eligible subjects will then participate in two series of 10 puffs of NJOY Kings spaced one hour apart. During the 2.5 hours of the testing day, the following will be measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4) craving for cigarettes and nicotine withdrawal symptoms will be assessed.
- Conditions
- Nicotine Dependence
- Being tested
- NJOY King 26 mg nicotine Electronic Nicotine Delivery System
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NJOY King 26 mg nicotine Electronic Nicotine Delivery SystemOther
NJOY® King ENDS, menthol or nonmenthol, ad libitum use for 1 week NJOY® King ENDS, menthol or nonmenthol, 2 series of puffs, with a 30-second interpuff interval in each series and 1 hour between the first puff in each series.
| Study group | Role | What they receive |
|---|---|---|
| NJOY King 26 mg nicotine Electronic Nicotine Delivery System | Experimental | Not described Receives: Other: NJOY King 26 mg nicotine Electronic Nicotine Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood nicotine levels
Note: Visit 3 can occur up to 28 days after the Screening Visit
Measured: Change from baseline at Visit 3 to 5, 10, 15 and 30 minutes after each of two series, spaced one hour, apart of 10 puff from the NJOY King at Visit 3
Change in average cigarettes smoked per day
Subjects will have a one weeks supply of NJOY Kings to use as they like. Mean cigarettes per day during the "actual use week" will be compared to the mean cigarettes per day for the baseline week (which is one week before the "actual use" week)
Measured: The baseline week compared to the week testing the NJOY Kings in the "real world"
Average NJOY Kings puffs used per day
Mean number of puffs per day of NJOY King ENDS used during Day 1 through Day 6 of the actual use week which can begin 1 to 3 weeks after the Screening Visit
Measured: Day 1 through Day 6 of the of testing the NJOY Kings in the "real world"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- LA Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- NJOY, Inc.
- Responsible party
- Principal investigator, Mitchell Nides, Ph.D., LA Clinical Trials
- Investigators
- MITCHELL NIDES, Ph.D., Principal investigator, LA Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898169
- Sponsor's protocol ID
- NJ-001 LACT
- Other IDs
- ISRCTN95345566
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma Nicotine, Carbon Monoxide, Heart Rate, Craving and Withdrawal After Acute Use of the NJOY King E-Cigarette in the Clinic, Following a One-Week Actual Use Pilot Study
- ClinicalTrials.gov ID
- NCT01898169
- Acronym / sponsor ID
- NJ-001 LACT
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- LA Clinical TrialsUniversity, hospital or other
- Collaborators
- NJOY, Inc.
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 12 Jul 2013 (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.
Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes have gained in popularity over the last several years. The technology used to manufacture ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content, e-liquids and flavorings. Only in the last few years have researchers begun to examine the health risks and benefits, nicotine blood levels, patterns of use, likability, and craving and withdrawal relief of ENDS. These studies have shown great variability in nicotine delivery, effects on heart rate, and relief of craving or withdrawal among various ENDS brands among tobacco cigarette smokers.
This study will test a new generation ENDS, the NJOY King Bold (NJOY, Scottsdale, AZ). It is a single use unit that resembles a traditional cigarette and delivers approximately 150 puffs. The cartridge inside contains 26 milligrams of nicotine.
Our primary objective is to evaluate the short-term effects of using the NJOY Kings ENDS on heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes and nicotine withdrawal. Our secondary objective is to evaluate the subject's usage patterns for cigarettes and NJOY King ENDS during a one-week period in which they can use each freely.
The study includes three visits to the clinic spaced approximately one week apart. Subjects who pass the screening visit will return to the clinic for Visit 2 in which they will sample the NJOY King ENDS for about 20 minutes before taking home enough to last till Visit 3, one week later. They will be instructed to use as many or as few as they like during the week. Subjects will keep a daily diary of number of tobacco cigarettes smoked and number of e-cigarette puffs taken. Subjects will return to the clinic for Visit 3 after 12 hours of abstinence from any form of nicotine in order to assure that they have no nicotine left in their bloodstream. Eligible subjects will then participate in two series of 10 puffs of NJOY Kings spaced one hour apart. During the 2.5 hours of the testing day, the following will be measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4) craving for cigarettes and nicotine withdrawal symptoms will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NJOY King 26 mg nicotine Electronic Nicotine Delivery System | Experimental | Other: NJOY King 26 mg nicotine Electronic Nicotine Delivery System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy cigarette smokers
- Not trying or planning to quit
- >10 factory-produced cigarettes/day for previous year
- Breath carbon monoxide level of >10 ppm at screening
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Abuse of drugs other than tobacco
- Use of any prescription psychoactive medications within 14 days
- Use of ENDS within 14 days
- Use of any nicotine replacement within 30 days
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 |
|---|---|---|
| NJOY King 26 mg nicotine Electronic Nicotine Delivery SystemNJOY® King ENDS, menthol or nonmenthol, ad libitum use for 1 week NJOY® King ENDS, menthol or nonmenthol, 2 series of puffs, with a 30-second interpuff interval in each series and 1 hour between the first puff in each series. | Other | NJOY King 26 mg nicotine Electronic Nicotine Delivery System |
Primary outcome
Change in blood nicotine levels
Time frame: Change from baseline at Visit 3 to 5, 10, 15 and 30 minutes after each of two series, spaced one hour, apart of 10 puff from the NJOY King at Visit 3
Note: Visit 3 can occur up to 28 days after the Screening Visit
Change in average cigarettes smoked per day
Time frame: The baseline week compared to the week testing the NJOY Kings in the "real world"
Subjects will have a one weeks supply of NJOY Kings to use as they like. Mean cigarettes per day during the "actual use week" will be compared to the mean cigarettes per day for the baseline week (which is one week before the "actual use" week)
Average NJOY Kings puffs used per day
Time frame: Day 1 through Day 6 of the of testing the NJOY Kings in the "real world"
Mean number of puffs per day of NJOY King ENDS used during Day 1 through Day 6 of the actual use week which can begin 1 to 3 weeks after the Screening Visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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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.
MITCHELL NIDES, Ph.D. principal investigator
LA Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NJOY King 26 mg nicotine Electronic Nicotine Delivery System in people with Nicotine Dependence, run by LA Clinical Trials 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jul 2013. 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?
Results are not available in the source record.
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 blood nicotine levels (time frame: Change from baseline at Visit 3 to 5, 10, 15 and 30 minutes after each of two series, spaced one hour, apart of 10 puff from the NJOY King at Visit 3). The study lists 3 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 12 Jul 2013.