CSD170301: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Four Different Electronic Cigarettes

NCT03105804 | Completed

• 1 other identifier: CSD170301
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four different marketed electronic cigarettes. Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.

Conditions

Smoking

Outcome Measures

Primary Outcomes (2)

• Cmax (Maximum baseline-adjusted nicotine plasma concentration)

  To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.

  -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes

• AUCnic0-60

  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.

  -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes

Secondary Outcomes (2)

• Tmax and AUCnic0-15

  -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes

• PLoverall

  13 Minutes

Study Arms (4)

FT21039 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT21039 followed by a 2 day in-clinic period.

Other: FT21039

FT21041 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT21041 followed by a 2 day in-clinic period.

Other: FT21041

FT21044 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT21044 followed by a 2 day in-clinic period.

Other: FT21044

FT21042 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT21042 followed by a 2 day in-clinic period.

Other: FT21042

Interventions

FT21039 OTHER

An electronic cigarette

FT21039 Group

FT21041 OTHER

An electronic cigarette

FT21041 Group

FT21044 OTHER

An electronic cigarette

FT21044 Group

FT21042 OTHER

An electronic cigarette

FT21042 Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
• Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit.
• Subjects must meet one (a or b) of the following tobacco use conditions:
• Exclusive cigarette smoker who self-reports smoking at least (≥) 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 Investigator.
• Dual user of combustible cigarettes and ECs who self-reports: 1. Smoking at least (≥) 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 Investigator and 2. 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.
• Willing to be confined overnight and abstain from tobacco- and nicotine- containing product use for 12 hours prior to IP use through Study Discharge.
• Willing to use assigned IP during the study according to protocol.
• Expired breath carbon monoxide (ECO) level is ≥10 parts per million (ppm) at the Screening Visit and Study Day 1.
• Positive urine cotinine test at the Screening Visit and Study Day 1.
• No intent to quit smoking or vaping from Screening to Study Day 2.
• Females of childbearing age must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit.

You may not qualify if:

• Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the Screening Visit, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, diabetes, asthma or other 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.
• At risk for heart disease, as determined by the Investigator.
• Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥ 95 mmHg, measured after being seated for 5 minutes.
• Weight of ≤ 110 pounds.
• Poor peripheral venous access.
• Use of medicine for treatment of depression or asthma (e.g., paroxetine \[Paxil®\], montelukast \[Singulair®\], albuterol \[Proventil® HFA\]), as deemed clinically significant by the Investigator.
• 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.
• History or presence of hemophilia or other bleeding disorders.
• History or presence of clotting disorders with concomitant use of anticoagulants (e.g., clopidogrel \[Plavix®\], warfarin \[Coumadin®, Jantoven®\] and aspirin \[\> 325 mg/day\]).
• 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.
• Positive test for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibody (anti-HCV).
• 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.
• A positive urine drug screen without disclosure of corresponding concomitant medication(s) at the Screening Visit or on Study Day 1.
• A positive alcohol breathalyzer result at Screening Visit or on Study Day 1.

Sponsors & Collaborators

• RAI Services Company: lead
• Inflamax Research Incorporated: collaborator
• Davita Clinical Research: collaborator

Study Sites (2)

Inflamax Research, Inc.

Neptune City, New Jersey, 07753, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Frank Lee, MD

  Inflamax Research Incorporated

  PRINCIPAL INVESTIGATOR

• Margarita Nunez, MD

  High Point Clinical Trial Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: March 29, 2017
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)