SmokingNCT03170674
CSD170501: Study to Assess Biomarkers of Tobacco Exposure in Smokers During In-Clinic Confinement Switch to an Electronic Cigarette
A study testing FT21039, FT21092 and FT21018 in people with Smoking, run by RAI Services Company at 2 sites in United States.
Trial summary
The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of the three electronic cigarettes or abstinence. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- FT21039, FT21092 and FT21018
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2017to 18 Aug 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English;
- Generally healthy males or females, 21 to 60 years of age (inclusive);
- Screening expired carbon monoxide (ECO) level ≥ 12 parts per million (ppm);
- Self-reports that cigarettes are the only tobacco or nicotine-containing product used within 30 days of the Screening Visit (Note: Rare use of other products [e.g., cigar or bridging therapy with NRT] may be acceptable in consultation with the Sponsor);
- Self-reports at the Screening Visit smoking on average at least 10 cigarettes per day that are filtered, non-menthol, 83 mm to 100 mm length and inhaling the smoke for at least 6 months prior to the Screening Visit (Note: Smokers who use menthol cigarette products like Camel Crush are not eligible for the study);
- Positive urine cotinine test at Screening and Enrollment;
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- Willing to switch from current cigarette to one of the Investigational Products or to abstain from smoking for approximately 7 days during in-clinic confinement;
- Females of childbearing potential must be willing to use a form of contraception acceptable to the Investigator from the time of signing the ICF until Study Discharge or be surgically sterile for at least 90 days prior to the Screening Visit;
- Able to safely perform the required study procedures, as determined by the Investigator.
Who cannot join
- Clinically significant or unstable/uncontrolled acute or chronic medical conditions at screening, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., hypertension, chronic lung disease, heart disease, neurological disease, or psychiatric disorders) based on screening assessments such as safety labs, medical history, and physical/oral examinations;
- Self-reports or safety labs that indicate diabetes;
- Use of medicine for treatment of depression, unless on a stable dose for the past 6 months prior to screening and deemed clinically stable by the PI.
- Current scheduled treatment for asthma within the past consecutive 12 months prior to screening. As needed treatment, such as inhalers, may be included at the PIs discretion pending approval from the medical monitor.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for 5 minutes (at Screening or Day -2 Check-in);
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- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV);
- Clinically significant hemoglobin level, < 5% of the Lower Limit of Normal (LLN), as determined by the Investigator at Screening;
- History or presence of hemophilia or any other bleeding or clotting disorders;
- Use of anticoagulants (e.g., clopidogrel [Plavix®], warfarin [Coumadin®, Jantoven®], aspirin [> 325 mg/day]) at least 30 days prior to screening;
- Given a whole blood donation within 8 weeks (≤56 days) prior to enrollment;
- Plasma donation within ≤ 7 days prior to enrollment;
- Weight of ≤ 110 pounds;
- Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of Screening) to participate in this study;
- Employed by a tobacco company, the clinical study site, or handles e-liquids or unprocessed tobacco as part of his/her job;
- Use of any medication or supplement that aids in smoking cessation including, but not limited to, any nicotine replacement therapy (NRT) unless used for short term bridging therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix), bupropion (Wellbutrin, Zyban), or lobelia extract within 30 days of the Screening Visit;
- Use of injectable forms of medication(s) for the duration of the study, unless acceptable in the opinion of the Investigator or with the exception of injectable forms of birth control that are not required to be administered during the study period;
- Self-reports drinking more than 14 servings of alcoholic beverages per week (1 serving = 12 oz of beer, 6 oz of wine, or 1.5 oz of liquor);
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study;
- Females ≥35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy for menopause-related symptoms;
- A positive urine drug screen without disclosure of corresponding prescribed concomitant medication(s) at the Screening Visit or Enrollment;
- A positive alcohol test at Screening or Enrollment;
- Regularly exposed to solvent fumes or gasoline (e.g., painter, auto mechanic);
- Participation in another clinical study within 30 days prior to the time of consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to time of consent of the current study;
- Determined by the Investigator to be inappropriate for this study, including a subject who is unable to communicate or unwilling to cooperate with the clinical staff;
- Unable or unwilling to participate in the in-clinic confinement for the full study duration (total of 10 days).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
About this study
Official title: CSD170501: A Randomized, Controlled Study to Assess Biomarkers of Tobacco Exposure in Smokers During In-Clinic Confinement Switch to an Electronic Cigarette
The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of the three electronic cigarettes or abstinence.
Read the detailed description
This will be a two-center, randomized, controlled, switching, open-label, parallel cohort study. The study will compare biomarkers of tobacco exposure from subjects at baseline levels of biomarkers of tobacco exposure after they have switched to one of three electronic cigarettes or abstinence for 5 days.
- Conditions
- Smoking
- Being tested
- FT21039, FT21092, FT21018
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT21039Other
an electronic cigarette product
FT21092Other
an electronic cigarette product
FT21018Other
an electronic cigarette product
| Study group | Role | What they receive |
|---|---|---|
| FT21039 Product Use Group | Experimental | Subjects will use the electronic cigarette product (FT21039). Receives: Other: FT21039 |
| FT21092 Product Use Group | Experimental | Subjects will use the electronic cigarette product (FT21092). Receives: Other: FT21092 |
| FT21018 Product Use Group | Experimental | Subjects will use the electronic cigarette product (FT21018). Receives: Other: FT21018 |
| Abstinence Group | No intervention | Subjects in the Abstinence Group will not be assigned any products. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5
A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence.
Biomarkers of tobacco exposure in urine include:
- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) (NNAL) + glucuronides
- N'-nitrosonornicotine (NNN) + glucuronides
- 4-aminobiphenyl
- 1-aminonaphthalene
- 2-aminonaphthalene
- o-toluidine
- S-phenyl mercapturic acid (SPMA)
- 3-hydroxy-1-methylpropyl-mercapturic acid (HMPMA)
- 2-cyanoethyl mercapturic acid (CEMA)
- Monohydroxybutyl mercapturic acid (MHBMA)
- 3-hydroxypropyl mercapturic acid (HPMA)
- 3-hydroxy-benzo[a]pyrene
Measured: 5 days
Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5
A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence.
Biomarkers of tobacco exposure in blood include:
- Carboxyhemoglobin
Measured: 5 days
Secondary outcomes (2)
Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5
A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence.
Biomarkers of tobacco exposure in urine include:
- Unconjugated nicotine
- Unconjugated cotinine
- Unconjugated trans-3'-hydroxycotinine
- Nicotine-N-glucuronide
- Cotinine-N-glucuronide
- Trans-3'-hydroxycotinine-O-glucuronide
Measured: 5 days
Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5
A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence.
Biomarkers of tobacco exposure in blood include:
- Plasma nicotine
- Plasma cotinine
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start15 May 2017
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by RAI Services CompanyThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vince & Associates Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Debra Kelsh, MD, Principal investigator, Vince & Associates Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170674
- Sponsor's protocol ID
- CSD170501
- Status last verified
- Sep 2017
- First submitted
- 24 May 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD170501: A Randomized, Controlled Study to Assess Biomarkers of Tobacco Exposure in Smokers During In-Clinic Confinement Switch to an Electronic Cigarette
- ClinicalTrials.gov ID
- NCT03170674
- Acronym / sponsor ID
- CSD170501
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Vince & Associates Clinical Research, Inc.
- Study start
- 15 May 2017 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of the three electronic cigarettes or abstinence.
Detailed description
This will be a two-center, randomized, controlled, switching, open-label, parallel cohort study. The study will compare biomarkers of tobacco exposure from subjects at baseline levels of biomarkers of tobacco exposure after they have switched to one of three electronic cigarettes or abstinence for 5 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FT21039 Product Use Group | Experimental | Other: FT21039Subjects will use the electronic cigarette product (FT21039). |
| FT21092 Product Use Group | Experimental | Other: FT21092Subjects will use the electronic cigarette product (FT21092). |
| FT21018 Product Use Group | Experimental | Other: FT21018Subjects will use the electronic cigarette product (FT21018). |
| Abstinence Group | No intervention | –Subjects in the Abstinence Group will not be assigned any products. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English;
- Generally healthy males or females, 21 to 60 years of age (inclusive);
- Screening expired carbon monoxide (ECO) level ≥ 12 parts per million (ppm);
- Self-reports that cigarettes are the only tobacco or nicotine-containing product used within 30 days of the Screening Visit (Note: Rare use of other products [e.g., cigar or bridging therapy with NRT] may be acceptable in consultation with the Sponsor);
- Self-reports at the Screening Visit smoking on average at least 10 cigarettes per day that are filtered, non-menthol, 83 mm to 100 mm length and inhaling the smoke for at least 6 months prior to the Screening Visit (Note: Smokers who use menthol cigarette products like Camel Crush are not eligible for the study);
Key exclusion criteria (26 listed)
- Clinically significant or unstable/uncontrolled acute or chronic medical conditions at screening, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., hypertension, chronic lung disease, heart disease, neurological disease, or psychiatric disorders) based on screening assessments such as safety labs, medical history, and physical/oral examinations;
- Self-reports or safety labs that indicate diabetes;
- Use of medicine for treatment of depression, unless on a stable dose for the past 6 months prior to screening and deemed clinically stable by the PI.
- Current scheduled treatment for asthma within the past consecutive 12 months prior to screening. As needed treatment, such as inhalers, may be included at the PIs discretion pending approval from the medical monitor.
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
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 |
|---|---|---|
| FT21039an electronic cigarette product | Other | FT21039 Product Use Group |
| FT21092an electronic cigarette product | Other | FT21092 Product Use Group |
| FT21018an electronic cigarette product | Other | FT21018 Product Use Group |
Primary outcome
Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5
Time frame: 5 days
A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in urine include: 1. 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) (NNAL) + glucuronides 2. N'-nitrosonornicotine (NNN) + glucuronides 3. 4-aminobiphenyl 4. 1-aminonaphthalene 5. 2-aminonaphthalene 6. o-toluidine 7. S-phenyl mercapturic acid (SPMA) 8. 3-hydroxy-1-methylpropyl-mercapturic acid (HMPMA) 9. 2-cyanoethyl mercapturic acid (CEMA) 10. Monohydroxybutyl mercapturic acid (MHBMA) 11. 3-hydroxypropyl mercapturic acid (HPMA) 12. 3-hydroxy-benzo[a]pyrene
Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5
Time frame: 5 days
A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in blood include: 1. Carboxyhemoglobin
2 secondary outcomes
Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5
Time frame: 5 days
Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5
Time frame: 5 days
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 8 Sep 2017.
- 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.
Debra Kelsh, MD principal investigator
Vince & Associates Clinical Research, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FT21039, FT21092 and FT21018 in people with Smoking, run by RAI Services Company at 2 sites 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 9 inclusion and 26 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 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5 (time frame: 5 days). The study lists 2 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 8 Sep 2017.