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

NCT03294356 | Completed

• 1 other identifier: CSD170304
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 5

Brief Summary

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.

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 (6)

FT210771 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT210771 followed by a 2 day in-clinic period.

Other: FT210771

FT210751 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette FT210751 followed by a 2 day in-clinic period.

Other: FT210751

6T30134157764 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette 6T30134157764 followed by a 2 day in-clinic period.

Other: 6T30134157764

G41A7C071 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette G41A7C071 followed by a 2 day in-clinic period.

Other: G41A7C071

M011161212 Group

EXPERIMENTAL

7 day at-home use of electronic cigarette M011161212 followed by a 2 day in-clinic period.

Other: M011161212

FT21002 Group

EXPERIMENTAL

7 day at-home use of combustible cigarette FT21002 followed by a 2 day in-clinic period.

Other: FT21002

Interventions

FT210771 OTHER

An electronic cigarette

FT210771 Group

FT210751 OTHER

An electronic cigarette

FT210751 Group

6T30134157764 OTHER

An electronic cigarette

6T30134157764 Group

G41A7C071 OTHER

An electronic cigarette

G41A7C071 Group

M011161212 OTHER

An electronic cigarette

M011161212 Group

FT21002 OTHER

A combustible cigarette

FT21002 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 ≥ 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).
• 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.
• 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.
• 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 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.

You may not qualify if:

• 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.
• At risk for heart disease, as determined by the PI.
• 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 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.
• 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.
• 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 \[Coumadin®, Jantoven®\], 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 or who 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
• Covance: collaborator

Study Sites (5)

Clinical Research Consortium (CRC)

Tempe, Arizona, 85283, United States

Location

Central Kentucky Research Associates (CKRA)

Lexington, Kentucky, 40509, United States

Location

St. Louis Clinical Trials (SLCT)

St Louis, Missouri, 63141, United States

Location

Midwest Clinical Research (MCRC)

Dayton, Ohio, 45417, United States

Location

New Orleans Center for Clinical Research (NOCCR)

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• 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)

  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: September 22, 2017
• First Posted: September 27, 2017
• Study Start: September 13, 2017
• Primary Completion: November 2, 2017
• Study Completion: November 2, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)