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SmokingNCT03126357

CSD170401: Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement

A study testing Product A, Product B and Product C in people with Smoking, run by RAI Services Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine elements of abuse liability (AL) related to potential product adoption of three electronic tobacco vapor products by current smokers relative to high and low AL comparator products (usual brand cigarette and nicotine gum, respectively). 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?
Product A, Product B and Product C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
17 Apr 2017to 25 May 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 male or female, 21 to 60 years of age, inclusive, at the time of consent.
  • Able to safely perform the required study procedures, as determined by the Investigator.
  • Expired breath carbon monoxide level is ≥ 15 ppm and ≤ 100 ppm at Screening and Day 1.
  • Smokes only combustible, filtered, non-menthol cigarettes, 83 mm to 100 mm in length.
  • Agrees to smoke same usual brand (UB) cigarette throughout the study period. Usual brand cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
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  • Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Investigator.
  • Response at Screening to Fagerström Test for Cigarette Dependence (FTCD) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes."
  • Willing to use UB cigarette, electronic tobacco vapor products, and Nicorette gum during the study period.
  • Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each Test Session.
  • Females of childbearing potential must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until study discharge. Examples of acceptable forms of contraception include, but are not limited to, the following.
  • Surgeries:
  • Hysterectomy at least 6 months prior to randomization
  • Oophorectomy at least 6 months prior to randomization
  • Tubal ligation at least 6 months prior to randomization
  • Transcervical sterilization at least 6 months prior to randomization
  • Hormonal birth control at least 3 months prior to randomization
  • Non-hormonal intrauterine device at least 3 months prior to randomization
  • Double barrier methods (e.g., condom and spermicide) at least 14 days prior to randomization
  • Abstinence at least 14 days prior to randomization
  • Vasectomized partner is acceptable birth control for females provided the surgery was performed at least 6 months prior to randomization
  • Postmenopausal at least 1 year prior to randomization and have follicle-stimulating hormone (FSH) levels consistent with postmenopausal status at screening as per Investigator or designee judgment
  • Agrees to in-clinic confinement of 11 days and 10 nights.

Who cannot join

  • Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at Screening or Day 1, as determined by the Investigator, that would preclude the subject from participating safely in the study (e.g., uncontrolled hypertension, lung disease, cardiac disease, neurological disease or psychiatric disorders) based on safety assessments such as clinical laboratory tests, medical history, and physical/oral examinations.
  • History, presence of, or clinical laboratory test results indicating diabetes.
  • History or presence of stomach ulcers.
  • At risk for heart disease that would preclude the subject from participating safely in the study, as determined by the Investigator.
  • Use of medicine for the 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.
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  • 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 diastolic blood pressure of > 95 mmHg at Screening, measured after being seated for at least 5 minutes.
  • Hemoglobin level is < 12 g/dL at Screening.
  • Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
  • History or presence of hemophilia or any other bleeding disorders.
  • History or presence of clotting disorders and/or use of anticoagulants (e.g., clopidogrel [Plavix®], warfarin [Coumadin®, Jantoven®] and aspirin [> 325 mg/day], see Section 7.4 "Concomitant Medications").
  • Whole blood donation within 8 weeks (≤ 56 days) prior to Screening.
  • Plasma donation within (≤) 7 days prior to Screening.
  • Body mass index < 18.5 or > 40.0 kg/m2 at Screening.
  • Weight of ≤ 110 pounds at Screening.
  • Poor peripheral venous access.
  • Postponing a decision to quit smoking (defined as planning a quit attempt within [≤] 30 days of Screening) to participate in this study or previous attempt within (≤) 30 days prior to Screening.
  • Employed by a tobacco company, the study site, or handles unprocessed tobacco as part of his or her job.
  • Use of any medication or supplement that aids smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to Screening.
  • Use of an electronic tobacco vapor product or other tobacco or nicotine-containing product (e.g., lozenges, moist snuff) within (≤) 30 days prior to Screening.
  • Drinks more than 14 servings of alcoholic beverages per week (one 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 who intend to become pregnant during the course of the study.
  • Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
  • A positive urine drug screen without disclosure of corresponding prescribed concomitant medication(s), at Screening or Day 1.
  • A positive alcohol result at Screening or Day 1.
  • Determined by the Investigator to be inappropriate for this study, including a subject who is unable to communicate or unwilling to cooperate with the study staff.
  • Participation in another clinical trial within (≤) 30 days prior to Screening. The 30-day window for each subject will be derived from the date of the last study event in the previous study to Screening of the current study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion, Inc.

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: CSD170401: A Single-Center, Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement

This study will examine elements of abuse liability (AL) related to potential product adoption of three electronic tobacco vapor products by current smokers relative to high and low AL comparator products (usual brand cigarette and nicotine gum, respectively). Changes in subjective measures, speed and amount of nicotine uptake, and maximum changes in physiological effects during and after product use that follows a 12-hour (minimum) tobacco and nicotine abstinence period, will be determined. The electronic tobacco vapor products will not be compared to each other.

Read the detailed description

This is a single-center, randomized, open-label, crossover study, designed to evaluate subjective effects (i.e., Product Liking [PL], Overall Intent to Use Again [OIUA], Product Effects [PE], Urge to Smoke [UTS], and Overall Product Liking [OPL]), plasma nicotine uptake, and physiological measures (blood pressure and heart rate) during and following ad libitum use of the following five IPs by healthy subjects. Subjects will be evaluated in five separate Test Sessions and the active period of each Test Session will last for approximately 4 hours during and following IP use.

Conditions
Smoking
Being tested
Product A, Product B, Product C, Product D, Product E
Medical subject headings
Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Product AOther

    Usual Brand Cigarette

  • Product BOther

    FT21039 an electronic tobacco vapor product

  • Product COther

    FT21092 an electronic tobacco vapor product

  • Product DOther

    FT21018 an electronic tobacco vapor product

  • Product EOther

    4mg nicotine gum

Study groups in NCT03126357
Study groupRoleWhat they receive
Product usage order ABECDExperimentalSubjects will use each of the 5 products (ABECD) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order BCADEExperimentalSubjects will use each of the 5 products (BCADE) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order CDBEAExperimentalSubjects will use each of the 5 products (CDBEA) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order DECABExperimentalSubjects will use each of the 5 products (DECAB) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order EADBCExperimentalSubjects will use each of the 5 products (EADBC) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order DCEBAExperimentalSubjects will use each of the 5 products (DCEBA) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order EDACBExperimentalSubjects will use each of the 5 products (EDACB) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order AEBDCExperimentalSubjects will use each of the 5 products (AEBDC) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order BACEDExperimentalSubjects will use each of the 5 products (BACED) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E
Product usage order CBDAEExperimentalSubjects will use each of the 5 products (CBDAE) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUECPL 15-240

    Area under the product liking (PL) NRS score-versus-time curve from 15 minutes to 240 minutes after the start of investigational product (IP) use.

    Measured: -5, 5, 15, 30, 45, 60, 90, 120, 150, 180, and 240 Minutes

  2. Emax PL

    Maximum response for product effects with regards to PL score after the start of IP use.

    Measured: -5, 5, 15, 30, 45, 60, 90, 120, 150, 180, and 240 Minutes

  3. Eoverall IUA

    Overall intent to use again (IUA), measured at 240 minutes after the start of IP use.

    Measured: 240 Minutes

  4. AUCnic 0-240

    Baseline-adjusted area under the nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use.

    Measured: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes.

  5. Cmax

    Maximum baseline-adjusted plasma concentration.

    Measured: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes.

  6. Tmax

    Time to maximum baseline-adjusted plasma concentration.

    Measured: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start17 Apr 2017
  3. Primary completion25 May 2017
  4. Study completion25 May 2017

Resources

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
Crossover
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126357
Sponsor's protocol ID
CSD170401
Status last verified
Jun 2017
First submitted
19 Apr 2017
Last updated
27 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Product A, Product B and Product C in people with Smoking, run by RAI Services 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 23 inclusion and 28 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 27 Jun 2017. 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?

AUECPL 15-240 (time frame: -5, 5, 15, 30, 45, 60, 90, 120, 150, 180, and 240 Minutes). 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 NCT03126357.

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 27 Jun 2017.

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