Use Behavior, Nicotine Uptake, and Subjective Effects Comparison of Tobacco and Menthol e-Liquids by ENDS Consumers

NCT05134415 | Completed

• 1 other identifier: RELX-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to evaluate the impact of within-flavor category (tobacco and menthol) differences in e-liquid flavors on product use behaviors, nicotine uptake, and subjective effects by current ENDS consumers when used in a closed-system electronic nicotine delivery system (ENDS).

Conditions

Electronic Cigarette Use

Keywords

Electronic Nicotine Delivery System; Nicotine; Topography; Pharmacokinetics; E-cigarette; Subjective effects

Outcome Measures

Primary Outcomes (1)

• Study product use - daily pod use

  The number of pods used per day during the 14-day ambulatory period

  14 days

Secondary Outcomes (22)

• Study product use - e-liquid consumption per pod

  14 days

• Study product use - e-liquid consumption per day

  14 days

• Puff topography - number of puffs

  5 minutes

• Puff topography - duration of puffs

  5 minutes

• Puff topography - volume of puffs

  5 minutes

Study Arms (4)

Product Use Sequence 1

EXPERIMENTAL

Period 1 - RELX ENDS tobacco flavor 1 Period 2 - RELX ENDS tobacco flavor 2

Other: RELX ENDS Tobacco Flavor 1; Other: RELX ENDS Tobacco Flavor 2

Product Use Sequence 2

EXPERIMENTAL

Period 1 - RELX ENDS tobacco flavor 2 Period 2 - RELX ENDS tobacco flavor 1

Other: RELX ENDS Tobacco Flavor 1; Other: RELX ENDS Tobacco Flavor 2

Product Use Sequence 3

EXPERIMENTAL

Period 1 - RELX ENDS menthol flavor 1 Period 2 - RELX ENDS menthol flavor 2

Other: RELX ENDS Menthol Flavor 1; Other: RELX ENDS Menthol Flavor 2

Product Use Sequence 4

EXPERIMENTAL

Period 1 - RELX ENDS menthol flavor 2 Period 2 - RELX ENDS menthol flavor 1

Other: RELX ENDS Menthol Flavor 1; Other: RELX ENDS Menthol Flavor 2

Interventions

RELX ENDS Tobacco Flavor 1 OTHER

2-week ad libitum use of the RELX ENDS tobacco flavor 1

Product Use Sequence 1; Product Use Sequence 2

RELX ENDS Tobacco Flavor 2 OTHER

2-week ad libitum use of the RELX ENDS tobacco flavor 2

Product Use Sequence 1; Product Use Sequence 2

RELX ENDS Menthol Flavor 1 OTHER

2-week ad libitum use of the RELX ENDS menthol flavor 1

Product Use Sequence 3; Product Use Sequence 4

RELX ENDS Menthol Flavor 2 OTHER

2-week ad libitum use of the RELX ENDS menthol flavor 2

Product Use Sequence 3; Product Use Sequence 4

Eligibility Criteria

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

You may qualify if:

• Is 22 to 65 years of age, inclusive, at the time of consent.
• Has used a closed-system ENDS product on most days during the 60 days prior to Screening (no use on up to 8 days total is allowed). Dual use with open-system products will be allowed provided that the closed-system is the predominant system used (based on self-reported volume of e-liquid used).
• Reports a tobacco or menthol/mint flavored e-liquid as the most commonly used flavor (based on self-reported volume of e-liquid used) during the 30 days prior to screening.
• Agrees to maintain product use described in Criteria 3 and 4 from Screening through Test Visit 1.
• Has a urine cotinine concentration ≥ 200 ng/mL at Screening.
• Has an ECO concentration \< 10 ppm at Screening and Test Visit 1.
• 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 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/occlusion) or in a menopausal state (at least 1 year without menses).
• Is willing to comply with the requirements of the study.
• Provides voluntary consent to participate in the study as documented on the signed ICF.

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 at Screening, including, but not limited to, the following:
• Has a history of drug or alcohol abuse within 12 months of Screening.
• Has a systolic BP \<90 mmHg or \>160 mmHg, diastolic BP \<40 mmHg or \>95 mmHg, or HR \<40 bpm or \>99 bpm at Screening.
• Has previously been diagnosed with any form of cancer, except for basal cell or squamous epithelial carcinomas of the skin that have been resected.
• Has been treated chronically for depression, diabetes, asthma, emphysema, or chronic obstructive pulmonary disease within 12 months of Test Visit 1.
• Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Test Visit 1 that would jeopardize the safety of the subject or impact the validity of the study results.
• Subjects who, in the judgment of the study physician, have recent or active COVID 19 infection, as evidenced by the following:
• Endorsement of symptoms that could indicate COVID-19 during screening and/or
• Body temperature ≥100.4°F and/or
• Laboratory test results suggestive of active or recent exposure to SARS CoV 2.
• Has a BMI greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
• Is allergic to or intolerant of components of the product e-liquid, including but not limited to, menthol, propylene glycol, or glycerin.
• Has a positive urine drug or alcohol test at Screening..
• If female, has a positive pregnancy test, is breastfeeding or lactating, or intends to become pregnant from Screening through Test Visit 3.

Sponsors & Collaborators

• Cheerain HK Limited: lead

Study Sites (1)

Los Angeles Clinical Trials

Burbank, California, 91505, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Donald Graff, PharmD

  RELX International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the specific tobacco or menthol flavor variant used during each study period.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: November 26, 2021
• Study Start: October 12, 2021
• Primary Completion: November 12, 2021
• Study Completion: December 1, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)