CSD170302: Study to Assess Nicotine Uptake in Smokers From Electronic Cigarettes

NCT03233997 | Completed

• 1 other identifier: CSD170302
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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 (3)

• Tmax

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

• AUCnic0-15

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

• PLoverall

  13 Minutes

Study Arms (4)

FT21018 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT21018 followed by a 2 day in-clinic period.

Other: FT21018

FT21033 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT21033 followed by a 2 day in-clinic period.

Other: FT21033

FT21034 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT21034 followed by a 2 day in-clinic period.

Other: FT21034

FT21035 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT21035 followed by a 2 day in-clinic period.

Other: FT21035

Interventions

FT21018 OTHER

An electronic cigarette

FT21018 Group

FT21033 OTHER

An electronic cigarette

FT21033 Group

FT21034 OTHER

An electronic cigarette

FT21034 Group

FT21035 OTHER

An electronic cigarette

FT21035 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 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 electronic cigarettes (EC) who self-reports:
• i. 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 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.
• 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 the Screening Visit to Study Day 2.
• Females 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 \> 160 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, 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.
• 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 \[Coumadin®, Jantoven®\] or 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.

Sponsors & Collaborators

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

Study Sites (1)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Elizabeth Yoon, MSN, FNP-C

  Davita Clinical Research

  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: July 25, 2017
• First Posted: July 31, 2017
• Study Start: July 18, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)