Nicotine Uptake, Measures of Abuse Liability, and Puffing Topography With Use of RELX ENDS Products by Smokers

NCT04640285 | Completed

• 1 other identifier: RELX-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to evaluate nicotine uptake and exposure, the abuse liability, and puffing topography associated with the use of an electronic nicotine delivery system ENDS with tobacco- and menthol-flavored e-liquids in current smokers.

Conditions

Electronic Cigarette Use

Keywords

Electronic Nicotine Delivery System; Nicotine; Pharmacokinetics; Abuse Liability; Topography; E-cigarette

Outcome Measures

Primary Outcomes (2)

• Nicotine Uptake

  PK Session baseline-adjusted maximum plasma nicotine concentration \[Cmax\]

  120 minutes

• Nicotine Uptake

  PK Session baseline-adjusted area under the nicotine concentration-time curve \[AUC(0-120)\]

  120 minutes

Secondary Outcomes (23)

• Nicotine Uptake - PK Session

  15 minutes

• Nicotine Uptake - PK Session

  120 minutes

• Nicotine Uptake - Ad Libitum Session

  480 minutes

• Subjective Effects as measured by the Modified Product Evaluation Scale

  480 minutes

• Subjective effects as measured by the Future Intent to Use questionnaire

  480 minutes

Study Arms (4)

Product Use Sequence 1

EXPERIMENTAL

Period 1 - RELX ENDS Tobacco Flavor Period 2 - RELX ENDS Menthol Flavor Period 3 - Nicorette White Ice Mint Nicotine Polacrilex Gum Period 4 - Usual Brand Cigarette

Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Usual Brand Cigarette; Other: Nicorette White Ice Mint nicotine polacrilex gum

Product Use Sequence 2

EXPERIMENTAL

Period 1 - RELX ENDS Menthol Flavor Period 2 - Usual Brand Cigarette Period 3 - RELX ENDS Tobacco Flavor Period 4 - Nicorette White Ice Mint Nicotine Polacrilex Gum

Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Usual Brand Cigarette; Other: Nicorette White Ice Mint nicotine polacrilex gum

Product Use Sequence 3

EXPERIMENTAL

Period 1 - Usual Brand Cigarette Period 2 - Nicorette White Ice Mint Nicotine Polacrilex Gum Period 3 - RELX ENDS Menthol Flavor Period 4 - RELX ENDS Tobacco Flavor

Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Usual Brand Cigarette; Other: Nicorette White Ice Mint nicotine polacrilex gum

Product Use Sequence 4

EXPERIMENTAL

Period 1 - Nicorette White Ice Mint Nicotine Polacrilex Gum Period 2 - RELX ENDS Tobacco Flavor Period 3 - Usual Brand Cigarette Period 4 - RELX ENDS Menthol Flavor

Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Usual Brand Cigarette; Other: Nicorette White Ice Mint nicotine polacrilex gum

Interventions

RELX ENDS Tobacco Flavor OTHER

Ad libitum use of RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions

Product Use Sequence 1; Product Use Sequence 2; Product Use Sequence 3; Product Use Sequence 4

RELX ENDS Menthol Flavor OTHER

Ad libitum use of RELX ENDS Menthol flavor product during 8-hour and 5-minute use sessions

Product Use Sequence 1; Product Use Sequence 2; Product Use Sequence 3; Product Use Sequence 4

Usual Brand Cigarette OTHER

Ad libitum use of subjects usual brand product during 8-hour and single cigarette use sessions

Product Use Sequence 1; Product Use Sequence 2; Product Use Sequence 3; Product Use Sequence 4

Nicorette White Ice Mint nicotine polacrilex gum OTHER

Ad libitum use of Nicorette White Ice Mint nicotine polacrilex gum product during 8-hour and 30-minute use sessions

Product Use Sequence 1; Product Use Sequence 2; Product Use Sequence 3; Product Use Sequence 4

Eligibility Criteria

• Age: 22 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provides voluntary consent to participate in the study as documented on the signed informed consent form (ICF).
• Is 22 to 59 years of age, inclusive, at the time of consent.
• Has been a smoker for at least 12 months prior to Screening and through check-in. 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) ≥ 30 days prior to Screening will be permitted at the discretion of the Investigator.
• Reports typically smoking 10 combustible cigarettes (king size or 100s) per day at Screening.
• Has a urine cotinine concentration ≥ 200 ng/mL at Screening and Check-in.
• Has an exhaled carbon monoxide (ECO) concentration \> 10 ppm at Screening and Check-in.
• If female, must meet 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, during the study, and for at least 30 days after the last product use. 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 and for at least 30 days after the last product use.
• If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels (≥ 40 mIU/mL).
• Is willing to comply with the requirements of the study.

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 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, ECG, or clinical laboratory results.
• Has a positive test for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb).
• Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Check-in.
• Has a fever (\> 100.5°F) at Screening or Check-in.
• Has a positive COVID-19 test during the screening period, prior to Check-in.
• Has a body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
• Has a history of drug or alcohol abuse within 12 months of Screening.
• Has a systolic BP \< 90 mmHg or \> 150 mmHg, diastolic BP \< 40 mmHg or \> 95 mmHg, or HR \< 40 bpm or \> 99 bpm at Screening.
• Is allergic to or intolerant of components of the product e-liquid, including but not limited to, menthol, propylene glycol or glycerin.
• Is unable to use the CReSS topography device with the vaping device during the training session on Day -1.
• Has an estimated creatinine clearance \< 70 mL/minute (using the Cockcroft Gault equation) at Screening.
• Has a positive urine drug or alcohol test at Screening or Check-in. A positive test result for cannabinoids may be permitted if the result to the cannabis intoxication evaluation is negative at Check-in.
• If female, has a positive pregnancy test, is breastfeeding or lactating, or intends to become pregnant from Screening through Day 5.
• Has been treated for depression, diabetes, asthma, emphysema, or chronic obstructive pulmonary disease within 12 months of Check-in.

Sponsors & Collaborators

• Cheerain HK Limited: lead

Study Sites (1)

Altasciences Clinical Kansas, Inc

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Donald Graff, PharmD

  Sponsor Representative

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: November 3, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 19, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)