SmokingNCT02210754
Characterization of Nicotine Exposure and Urge-to-Smoke Following Use of Electronic and Conventional Cigarettes
A study of Smoking, run by Lorillard Tobacco Company at 1 site in United States.
Trial summary
This trial was the initial characterization of the blu™ products being studied, with the purpose of gaining an understanding of the exposure to nicotine and craving reduction attained following use of blu™ e-cigarettes by adult smokers. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2014
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male and female smokers
- 21 to 65 years of age, inclusive, at Screening.
- Smoker for at least 12 months prior to Check-in
- Currently smoked an average of 10 or more manufactured cigarettes per day (no restriction on brand-style, king size [ approx. 83 - 85 mm] and 100s [approximately 98 - 100 mm] only)
- A history of e-cigarette use was allowed.
- Females of childbearing potential agreed to use a PI-approved method of contraception
Who cannot join
- Use of tobacco- or nicotine-containing products other than manufactured cigarettes and e-cigarettes (e.g., roll-your-own cigarettes, bidis, snuff, snus, tablets, inhalers, pipes, cigars, chewing tobacco, nicotine replacement therapies [e.g., gum, patches, lozenges, nasal spray, or inhalers]) within 28 days prior to Day 1 product administration or during the study.
- Use of any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Day 1 product administration and throughout the study.
- Known hypersensitivity to menthol, glycerol, or propylene glycol (PG).
- Exhaled CO ≤ 10 ppm at Screening.
- Self-reported puffers (i.e., smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
- Use of medications known to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, and methoxsalen) within 3 months prior to Day 1 product administration.
- History of drug or alcohol abuse within 24 months of Day 1 product administration
- Female subjects who were pregnant, lactating, or intended to become pregnant from Screening through completion of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Nicotine Exposure and Urge-to-Smoke Following a Single Controlled Administration and Short-Term Ad Lib Use of Electronic Cigarettes and Conventional Cigarettes in Adult Smokers
This trial was the initial characterization of the blu™ products being studied, with the purpose of gaining an understanding of the exposure to nicotine and craving reduction attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were utilized: a single controlled administration and a short-term ad lib use. As smoking behaviors vary from smoker to smoker, a controlled administration allows for some standardization of nicotine "dose" for each of the study products to better understand their uptake characteristics as well as urge reduction achieved under controlled conditions. Further evaluation under ad lib product use conditions provides insight into product self-administration behaviors that will allow subjects to achieve acceptable levels of urge reduction. Comparisons were made to evaluate differences between blu™ formulations as well as to the market-leading conventional cigarette, Marlboro Gold King Size ("Marlboro cigarette').
Read the detailed description
This was a randomized, partially single-blinded, 6-period crossover study of 24 subjects.
The primary objectives of this study were to:
- characterize the rate and extent of nicotine exposure following a single controlled administration and ad lib use of blu™ e-cigarettes,
- characterize smoking urge following a single controlled administration and ad lib use of blu™ e cigarettes.
The secondary objectives of this study were to:
- Compare the pharmacokinetic (PK) profile of nicotine between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following a single controlled administration and ad lib use of each study product.
- Compare changes in smoking urge within and between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following a single controlled administration and ad lib use of each study product.
- Compare the changes in exhaled carbon monoxide (CO) within and between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following use of each study product.
- Assess the tolerability of each study product following short-term use.
Subjects were provided blu™ Classic Tobacco and Magnificent Menthol products containing 2.4% nicotine, glycerin vehicle for 1 week prior to participation in the study to familiarize themselves with the use of the products. Subjects were confined to the clinic for the entire study duration and abstained from use of nicotine containing products for a period of at least 36 hours prior to each product administration. Each product administration included a controlled product administration and a 1 hour ad lib use of the study products. The controlled product administration consisted of 50 inhalations of the assigned e-cigarette product (5-second inhalations at 30-second intervals) or smoking one Marlboro cigarette (30-second intervals with the subjects' normal inhalation duration) with inhalations monitored by the clinical staff. The start of the ad lib product use was 30 minutes following the start of the controlled product use. During ad lib use, subjects were allowed to self-administer the e-cigarette product as desired for the entire hour and were responsible for maintaining their own inhalation counts. During the ad lib cigarette product use, subjects requested the product from the staff as desired and maintained their own inhalation counts.
Pharmacokinetics: Blood samples for the measurement of plasma nicotine concentrations were taken by direct venipuncture at 10 minutes prior to, and 5, 10, 15, 20, 25, 30, 45, 60, 75, and 90 minutes following the start of the controlled product administration. Non-compartmental PK parameters such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve were calculated from the plasma nicotine concentration-time data.
Pharmacodynamics: Smoking urge was assessed using a 100 mm visual analog scale (VAS). Assessments occurred within 1 minute prior to the -10 (pre-product administration), 5, 15, 25, 30, 60, and 90-minute PK blood draws. The following non-compartmental Pharmacodynamic parameters were calculated from the smoking urge change-from-baseline data: Emax0-30, Emaxreduction0-30, AUEC0-30, tEmax0-30, AUEC30-90, and E90.
Other Measurements: Exhaled CO measurements occurred at approximately 20 minutes prior to the start of the controlled product use and at approximately 15 minutes following the end of the ad lib product use.
Tolerability: Adverse events, physical examinations, vital signs, ECGs, and laboratory safety tests were assessed to evaluate enrolment criteria and subject safety during the study.
- Conditions
- Smoking
- Being tested
- blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle), blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle), blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle), blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle), blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)
- Keywords
- Nicotine, Pharmacokinetics, Pharmacodynamics, blu e-cigs, Tolerability, Safety, Smoke urge
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)Other
electronic cigarettes
blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)Other
electronic cigarettes
blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)Other
electronic cigarettes
blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)Other
electronic cigarettes
blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)Other
electronic cigarettes
Marlboro CigaretteOther
cigarettes
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette 1 | Experimental | blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle) Receives: Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle); Other: Marlboro Cigarette |
| E-cigarette 2 | Experimental | blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/propylene glycol (PG) vehicle) Receives: Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle); Other: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle); Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle); Other: Marlboro Cigarette |
| E-cigarette 3 | Experimental | blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle) Receives: Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle); Other: Marlboro Cigarette |
| E-cigarette 4 | Experimental | blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle) Receives: Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle); Other: Marlboro Cigarette |
| E-cigarette 5 | Experimental | blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle) Receives: Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle); Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle); Other: Marlboro Cigarette |
| Combustible Cigarette | Active comparator | Marlboro Cigarette Receives: Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle); Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle); Other: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle); Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle); Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes
Measure plasma nicotine PK outcome measures such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve.
Measured: 6 months
Secondary outcomes (1)
Assess smoking urge scores on the Visual Analog Scale following use of electronic and regular cigarettes
Smoking urge was assessed using a 100 mm visual analog scale (VAS). Assessments occurred within 1 minute prior to the -10 (pre-product administration), 5, 15, 25, 30, 60, and 90-minute PK blood draws on Days 1, 3, 5, 7, 9, and 11. The 30-minute assessment was intended to coincide with the start of the ad lib product use. The following non-compartmental pharmacodynamic parameters were calculated from the smoking urge change-from-baseline data: Maximum smoking urge reduction and change-from-baseline from time zero to 30 minutes, area under the effect curve (smoking urge change-from-baseline) from time 0 to 30 minutes and 30 to 90 minutes,time of the maximum (positive or negative) smoking urge change-from-baseline from time 0 to 30 minutes and Observed smoking urge change-from-baseline at 90 minutes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionJul 2014
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 SmokingStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lorillard Tobacco Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael R. Gartner, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210754
- Sponsor's protocol ID
- Galileo
- Status last verified
- Aug 2014
- First submitted
- 30 Jul 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Ruiz CD, Graff DW, Yan XS. Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes. BMC Public Health. 2015 Sep 30;15:991. doi: 10.1186/s12889-015-2349-2.
PubMed 26424091
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Nicotine Exposure and Urge-to-Smoke Following a Single Controlled Administration and Short-Term Ad Lib Use of Electronic Cigarettes and Conventional Cigarettes in Adult Smokers
- ClinicalTrials.gov ID
- NCT02210754
- Acronym / sponsor ID
- Galileo
- Conditions
- Smoking
- Keywords
- Nicotine, Pharmacokinetics, Pharmacodynamics, blu e-cigs, Tolerability, Safety, Smoke urge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lorillard Tobacco CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Aug 2014 (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 trial was the initial characterization of the blu™ products being studied, with the purpose of gaining an understanding of the exposure to nicotine and craving reduction attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were utilized: a single controlled administration and a short-term ad lib use. As smoking behaviors vary from smoker to smoker, a controlled administration allows for some standardization of nicotine "dose" for each of the study products to better understand their uptake characteristics as well as urge reduction achieved under controlled conditions. Further evaluation under ad lib product use conditions provides insight into product self-administration behaviors that will allow subjects to achieve acceptable levels of urge reduction. Comparisons were made to evaluate differences between blu™ formulations as well as to the market-leading conventional cigarette, Marlboro Gold King Size ("Marlboro cigarette').
Detailed description
This was a randomized, partially single-blinded, 6-period crossover study of 24 subjects.
The primary objectives of this study were to:
- characterize the rate and extent of nicotine exposure following a single controlled administration and ad lib use of blu™ e-cigarettes,
- characterize smoking urge following a single controlled administration and ad lib use of blu™ e cigarettes.
The secondary objectives of this study were to:
- Compare the pharmacokinetic (PK) profile of nicotine between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following a single controlled administration and ad lib use of each study product.
- Compare changes in smoking urge within and between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following a single controlled administration and ad lib use of each study product.
- Compare the changes in exhaled carbon monoxide (CO) within and between selected blu™ formulations and between the blu™ products and Marlboro cigarettes following use of each study product.
- Assess the tolerability of each study product following short-term use.
Subjects were provided blu™ Classic Tobacco and Magnificent Menthol products containing 2.4% nicotine, glycerin vehicle for 1 week prior to participation in the study to familiarize themselves with the use of the products. Subjects were confined to the clinic for the entire study duration and abstained from use of nicotine containing products for a period of at least 36 hours prior to each product administration. Each product administration included a controlled product administration and a 1 hour ad lib use of the study products. The controlled product administration consisted of 50 inhalations of the assigned e-cigarette product (5-second inhalations at 30-second intervals) or smoking one Marlboro cigarette (30-second intervals with the subjects' normal inhalation duration) with inhalations monitored by the clinical staff. The start of the ad lib product use was 30 minutes following the start of the controlled product use. During ad lib use, subjects were allowed to self-administer the e-cigarette product as desired for the entire hour and were responsible for maintaining their own inhalation counts. During the ad lib cigarette product use, subjects requested the product from the staff as desired and maintained their own inhalation counts.
Pharmacokinetics: Blood samples for the measurement of plasma nicotine concentrations were taken by direct venipuncture at 10 minutes prior to, and 5, 10, 15, 20, 25, 30, 45, 60, 75, and 90 minutes following the start of the controlled product administration. Non-compartmental PK parameters such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve were calculated from the plasma nicotine concentration-time data.
Pharmacodynamics: Smoking urge was assessed using a 100 mm visual analog scale (VAS). Assessments occurred within 1 minute prior to the -10 (pre-product administration), 5, 15, 25, 30, 60, and 90-minute PK blood draws. The following non-compartmental Pharmacodynamic parameters were calculated from the smoking urge change-from-baseline data: Emax0-30, Emaxreduction0-30, AUEC0-30, tEmax0-30, AUEC30-90, and E90.
Other Measurements: Exhaled CO measurements occurred at approximately 20 minutes prior to the start of the controlled product use and at approximately 15 minutes following the end of the ad lib product use.
Tolerability: Adverse events, physical examinations, vital signs, ECGs, and laboratory safety tests were assessed to evaluate enrolment criteria and subject safety during the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| E-cigarette 1 | Experimental | Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle), Other: Marlboro Cigaretteblu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle) |
| E-cigarette 2 | Experimental | Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle), Other: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle), Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle), Other: Marlboro Cigaretteblu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/propylene glycol (PG) vehicle) |
| E-cigarette 3 | Experimental | Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle), Other: Marlboro Cigaretteblu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle) |
| E-cigarette 4 | Experimental | Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle), Other: Marlboro Cigaretteblu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle) |
| E-cigarette 5 | Experimental | Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle), Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle), Other: Marlboro Cigaretteblu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle) |
| Combustible Cigarette | Active comparator | Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle), Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle), Other: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle), Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle), Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)Marlboro Cigarette |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult male and female smokers
- 21 to 65 years of age, inclusive, at Screening.
- Smoker for at least 12 months prior to Check-in
- Currently smoked an average of 10 or more manufactured cigarettes per day (no restriction on brand-style, king size [ approx. 83 - 85 mm] and 100s [approximately 98 - 100 mm] only)
- A history of e-cigarette use was allowed.
Key exclusion criteria (8 listed)
- Use of tobacco- or nicotine-containing products other than manufactured cigarettes and e-cigarettes (e.g., roll-your-own cigarettes, bidis, snuff, snus, tablets, inhalers, pipes, cigars, chewing tobacco, nicotine replacement therapies [e.g., gum, patches, lozenges, nasal spray, or inhalers]) within 28 days prior to Day 1 product administration or during the study.
- Use of any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Day 1 product administration and throughout the study.
- Known hypersensitivity to menthol, glycerol, or propylene glycol (PG).
- Exhaled CO ≤ 10 ppm at Screening.
- Self-reported puffers (i.e., smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
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 |
|---|---|---|
| blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)electronic cigarettes | Other | Combustible Cigarette, E-cigarette 2 |
| blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)electronic cigarettes | Other | Combustible Cigarette, E-cigarette 1, E-cigarette 3, E-cigarette 5 |
| blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)electronic cigarettes | Other | Combustible Cigarette, E-cigarette 2 |
| blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)electronic cigarettes | Other | Combustible Cigarette, E-cigarette 5 |
| blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)electronic cigarettes | Other | Combustible Cigarette, E-cigarette 2, E-cigarette 4 |
| Marlboro Cigarettecigarettes | Other | E-cigarette 1, E-cigarette 2, E-cigarette 3, E-cigarette 4, E-cigarette 5 |
Primary outcome
Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes
Time frame: 6 months
Measure plasma nicotine PK outcome measures such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve.
1 secondary outcome
Assess smoking urge scores on the Visual Analog Scale following use of electronic and regular cigarettes
Time frame: 6 months
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 7 Aug 2014.
- Derived from this study: PubMed 26424091D'Ruiz CD, Graff DW, Yan XS. Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes. BMC Public Health. 2015 Sep 30;15:991. doi: 10.1186/s12889-015-2349-2.
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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.
Michael R. Gartner, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Smoking, run by Lorillard Tobacco Company 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 6 inclusion and 8 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 7 Aug 2014. 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?
Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes (time frame: 6 months). 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 NCT02210754, 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 7 Aug 2014.