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CSD170304: Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03294356
First Posted: September 27, 2017
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Covance
Information provided by (Responsible Party):
RAI Services Company
  Purpose
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five different marketed electronic cigarettes, or one combustible cigarette (CC). Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.

Condition Intervention
Smoking Other: FT210771 Other: FT210751 Other: 6T30134157764 Other: G41A7C071 Other: M011161212 Other: FT21002

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: CSD170304: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes

Further study details as provided by RAI Services Company:

Primary Outcome Measures:
  • Cmax (Maximum baseline-adjusted nicotine plasma concentration) [ Time Frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes ]
    To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.

  • AUCnic0-60 [ Time Frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes ]
    Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period.


Secondary Outcome Measures:
  • Tmax [ Time Frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes ]
    Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use.

  • AUCnic0-15 [ Time Frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes ]
    Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.

  • PLoverall [ Time Frame: 13 Minutes ]
    Overall product liking (PL) is an additional measure of how much the subject likes the product, and is indicative of their potential willingness to seek out use of the product again at a later point in time; measured 13 minutes after the start of IP use.


Enrollment: 210
Actual Study Start Date: September 13, 2017
Study Completion Date: November 2, 2017
Primary Completion Date: November 2, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FT210771 Group
7 day at-home use of electronic cigarette FT210771 followed by a 2 day in-clinic period.
Other: FT210771
An electronic cigarette
Experimental: FT210751 Group
7 day at-home use of electronic cigarette FT210751 followed by a 2 day in-clinic period.
Other: FT210751
An electronic cigarette
Experimental: 6T30134157764 Group
7 day at-home use of electronic cigarette 6T30134157764 followed by a 2 day in-clinic period.
Other: 6T30134157764
An electronic cigarette
Experimental: G41A7C071 Group
7 day at-home use of electronic cigarette G41A7C071 followed by a 2 day in-clinic period.
Other: G41A7C071
An electronic cigarette
Experimental: M011161212 Group
7 day at-home use of electronic cigarette M011161212 followed by a 2 day in-clinic period.
Other: M011161212
An electronic cigarette
Experimental: FT21002 Group
7 day at-home use of combustible cigarette FT21002 followed by a 2 day in-clinic period.
Other: FT21002
A combustible cigarette

Detailed Description:
This will be a single-center, randomized, open-label, parallel study during which up to 210 healthy adult subjects, consisting of 35 subjects per product group, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of five different marketed ECs or one CC in tobacco consumers who are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e., intermittent EC users).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
  2. Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit.
  3. Subjects must meet one (a or b) of the following tobacco use conditions:

    1. Exclusive cigarette smoker who self-reports smoking ≥ 10 cigarettes per day for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation will be allowed at the discretion of the Principal Investigator (PI).
    2. Dual user of CCs and ECs who self-reports:

    i. Smoking ≥ 10 cigarettes per day for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation will be allowed at the discretion of the PI; and ii. Using a nicotine-containing "cig-a-like" EC or a tank system EC either daily or at least weekly for at least 3 months prior to Screening Visit.

  4. Willing to be confined overnight and abstain from tobacco- and nicotine-containing product use (with the exception of study IP use) for 12 hours prior to IP use through Study Discharge.
  5. Willing to use assigned IP during the study according to protocol.
  6. Expired breath carbon monoxide (ECO) level is ≥ 10 parts per million (ppm) at the Screening Visit and Study Day 1.
  7. Positive urine cotinine test at the Screening Visit and Study Day 1.
  8. No intent to quit smoking or vaping from Screening to Study Day 2.
  9. Females of childbearing age must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit.

Exclusion Criteria:

  1. Presence of clinically significant or unstable/uncontrolled acute or chronic medical condition at the Screening Visit, as determined by the PI, that would preclude a subject from participating safely in the study (e.g.,, uncontrolled hypertension, chronic lung disease, cardiac disease, neurological disease, or psychiatric disorders) based on safety assessments such as clinical laboratory tests, pregnancy tests, medical history, and physical/oral examinations.
  2. At risk for heart disease, as determined by the PI.
  3. Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for 5 minutes.
  4. Weight of ≤ 110 pounds.
  5. Poor peripheral venous access.
  6. 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.
  7. Current on scheduled treatment(s) for asthma within the past consecutive 12 months prior to screening. If potential subject is on an as-needed treatment, such as rescue inhalers, subject may be included at the PI's discretion pending approval from the Medical Monitor.
  8. Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically or cryogenically removed.
  9. Use of any medication or substance that aids in 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 the Screening Visit.
  10. History or presence of hemophilia or other bleeding disorders.
  11. History or presence of clotting disorders with concomitant use of anticoagulants (e.g., clopidogrel [Plavix®], warfarin [Coumadin®, Jantoven®], aspirin [> 325 mg/day]).
  12. Participation in another clinical trial 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 the time of consent of the current study.
  13. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV).
  14. Females who have a positive pregnancy test or who are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
  15. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
  16. A positive urine drug screen without disclosure of prescribed corresponding concomitant medication(s) at the Screening Visit or on Study Day 1.
  17. A positive alcohol breathalyzer result at the Screening Visit or on Study Day 1.
  18. Employed by a tobacco or nicotine-manufacturing company, the study site, or handles tobacco or nicotine-containing products as part of their job.
  19. Determined by the PI to be inappropriate for the study, including a subject who is unable to communicate or unwilling to cooperate with the clinical staff.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294356


Locations
United States, Arizona
Clinical Research Consortium (CRC)
Tempe, Arizona, United States, 85283
United States, Kentucky
Central Kentucky Research Associates (CKRA)
Lexington, Kentucky, United States, 40509
United States, Missouri
St. Louis Clinical Trials (SLCT)
Saint Louis, Missouri, United States, 63141
United States, Ohio
Midwest Clinical Research (MCRC)
Dayton, Ohio, United States, 45417
United States, Tennessee
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
RAI Services Company
Covance
Investigators
Principal Investigator: Corey Anderson, MD Clinical Research Consortium (CRC)
Principal Investigator: Mark Adams, MD Central Kentucky Research Associates (CKRA)
Principal Investigator: Daniel Gruener, MD St. Louis Clinical Trials (SLCT)
Principal Investigator: Otto Dueno, MD Midwest Clinical Research (MCRC)
Principal Investigator: William Smith, MD New Orleans Center for Clinical Research (NOCCR)
  More Information

Responsible Party: RAI Services Company
ClinicalTrials.gov Identifier: NCT03294356     History of Changes
Other Study ID Numbers: CSD170304
First Submitted: September 22, 2017
First Posted: September 27, 2017
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action