Characterization of Product Use in Smokers Switching From Cigarettes to a RELX Electronic Nicotine Delivery System

NCT04708106 | Completed

• 1 other identifier: RELX-003
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 5

Brief Summary

The study will assess product use behaviors, biomarkers of exposure, subjective effects, and safety in smokers who switch to a RELX ENDS over 8-weeks.

Conditions

Electronic Cigarette Use

Keywords

Electronic Nicotine Delivery System; Biomarkers; Subjective Effects; Topography; E-cigarette

Outcome Measures

Primary Outcomes (3)

• Weekly RELX ENDS product use

  Self-reported number of RELX ENDS pods started each week.

  56 days

• Daily number of cigarettes smoked

  Self-reported number of cigarettes smoked daily by study week.

  56 days

• Number of puffs from the RELX ENDS each day

  Self-reported number of puffs from the RELX ENDS daily by study week (0, \< 100, ≥ 100 per day).

  56 days

Secondary Outcomes (17)

• Biomarkers of exposure measured in blood

  Baseline, Day 28, and Day 56

• Biomarkers of tobacco exposure measured in urine

  Baseline, Day 28, and Day 56

• Subjective effects as measured by the Penn State [Electronic] Cigarette Dependence Index (PS[E]CDI)

  Baseline, Day 14, Day 28, Day 42, and Day 56

• Subjective effects as measured by the Cough Questionnaire

  Baseline, Day 14, Day 28, Day 42, and Day 56

• Subjective effects as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)

  Baseline, Day 14, Day 28, Day 42, and Day 56

Study Arms (4)

RELX ENDS Tobacco Flavor

EXPERIMENTAL

Switch from combustible cigarettes to RELX ENDS Tobacco Flavor for 56 days

Other: RELX ENDS Tobacco Flavor

RELX ENDS Menthol Flavor

EXPERIMENTAL

Switch from combustible cigarettes to RELX ENDS Menthol Flavor for 56 days

Other: RELX ENDS Menthol Flavor

RELX ENDS Tobacco and Menthol Flavors

EXPERIMENTAL

Switch from combustible cigarettes to RELX ENDS Tobacco and Menthol Flavor for 56 days

Other: RELX ENDS Tobacco and Menthol Flavors

Continue-smoking

NO INTERVENTION

Continue smoking combustible cigarettes for 56 days

Interventions

RELX ENDS Tobacco Flavor OTHER

Ad libitum use of the RELX ENDS Tobacco Flavor product

RELX ENDS Tobacco Flavor

RELX ENDS Menthol Flavor OTHER

Ad libitum use of the RELX ENDS Menthol product

RELX ENDS Menthol Flavor

RELX ENDS Tobacco and Menthol Flavors OTHER

Ad libitum use of the RELX ENDS Tobacco and Menthol Flavor products

RELX ENDS Tobacco and Menthol Flavors

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides voluntary consent to participate in the study as documented on the signed informed consent form (ICF).
• Is 22 to 65 years of age, inclusive, at the time of consent.
• Is willing to comply with the requirements of the study.
• Reports typically smoking 5 or more combustible CPD at Screening.
• Has been a daily smoker for at least 12 months prior to Screening. Brief periods of non-smoking (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) ≥ 56 days prior to Screening will be permitted at the discretion of the Investigator.
• Has a positive urine cotinine test (≥ 200 ng/mL) at Screening and Test Visit 1.
• Has an exhaled carbon monoxide (ECO) value \> 10 ppm at Screening and Test Visit 1.
• Has daily access to a cell phone for daily product use reporting.
• If female, meets one of the following criteria:
• If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first product use and during the study. An acceptable method of contraception includes one of the following:
• Abstinence from heterosexual intercourse
• Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
• Intrauterine device (with or without hormones) OR agrees to use a double barrier method (e.g. condom and spermicide) during the study.
• If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels.

You may not qualify if:

• Has a history or presence of clinically significant uncontrolled gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the Investigator.
• Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
• Has a positive COVID-19 test at Screening or during the study.
• Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Test Visit 1.
• Has a fever (\> 100.5°F) at Screening or Test Visit 1.
• Has a body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
• Has a systolic blood pressure \< 90 mmHg or \> 150 mmHg, diastolic blood pressure \< 40 mmHg or \> 95 mmHg, or heart rate \< 40 bpm or \> 99 bpm at Screening.
• Has a post-bronchodilator forced expiratory volume in 1 second:forced vital capacity (FEV1:FVC) ratio \< 0.7 and FEV1 \< 50% of predicted at Screening.
• Has a post-bronchodilator FEV1 increase ≥ 12% and \> 200 mL from pre- to post-bronchodilator at Screening.
• Has used an ENDS product on \>7 days during each of the 3 months prior to Screening or any use from Screening to Test Visit 1 other than as may be required for this study.
• Reports use of a very-low nicotine content cigarette (e.g., Moonlight, Spectrum, VLN) as usual brand.
• Has used nicotine-containing products other than manufactured cigarettes (e.g., ENDS products (e-cigarettes), roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Test Visit 1.
• Has used any products for the purpose of smoking cessation, including, but not limited to, nicotine replacement therapies, varenicline (Chantix), or buproprion (Zyban) from 30 days prior to Screening through the duration of the study.
• Is a self-reported puffer (i.e., draws smoke from the cigarette into the mouth and throat but does not inhale).

Sponsors & Collaborators

• Cheerain HK Limited: lead

Study Sites (5)

Pillar Clinical Research

Bentonville, Arkansas, 72712, United States

Location

AMR - Lexington

Lexington, Kentucky, 40509, United States

Location

QPS

Springfield, Missouri, 65802, United States

Location

AMR - Las Vegas

Las Vegas, Nevada, 89119, United States

Location

AMR - Knoxville

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Donald Graff, PharmD

  Sponsor Representative

  STUDY DIRECTOR

• Mark Adams, MD

  AMR - Lexington

  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: January 8, 2021
• First Posted: January 13, 2021
• Study Start: October 15, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 7, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (5)