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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04620616

Electronic Cigarette Use

COMPLETED NA

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

NCT04640285

Electronic Cigarette Use

COMPLETED NA

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

NCT05134415

Electronic Cigarette Use

COMPLETED NA

CSD231005 Nicotine Pouch Biomarkers of Exposure

NCT06303115

Tobacco Use Smoking

COMPLETED NA

Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Menthol Electronic Cigarettes vs Combustible Menthol Cigarettes and Nicotine Gum

NCT02664012

Smoking

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Electronic Cigarette Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RELX ENDS Tobacco Flavor

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

Group Type EXPERIMENTAL

RELX ENDS Tobacco Flavor

Intervention Type OTHER

Ad libitum use of the RELX ENDS Tobacco Flavor product

RELX ENDS Menthol Flavor

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

Group Type EXPERIMENTAL

RELX ENDS Menthol Flavor

Intervention Type OTHER

Ad libitum use of the RELX ENDS Menthol product

RELX ENDS Tobacco and Menthol Flavors

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

Group Type EXPERIMENTAL

RELX ENDS Tobacco and Menthol Flavors

Intervention Type OTHER

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

Continue-smoking

Continue smoking combustible cigarettes for 56 days

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RELX ENDS Tobacco Flavor

Ad libitum use of the RELX ENDS Tobacco Flavor product

Intervention Type OTHER

RELX ENDS Menthol Flavor

Ad libitum use of the RELX ENDS Menthol product

Intervention Type OTHER

RELX ENDS Tobacco and Menthol Flavors

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Provides voluntary consent to participate in the study as documented on the signed informed consent form (ICF).
2. Is 22 to 65 years of age, inclusive, at the time of consent.
3. Is willing to comply with the requirements of the study.
4. Reports typically smoking 5 or more combustible CPD at Screening.
5. 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.
6. Has a positive urine cotinine test (≥ 200 ng/mL) at Screening and Test Visit 1.
7. Has an exhaled carbon monoxide (ECO) value \> 10 ppm at Screening and Test Visit 1.
8. Has daily access to a cell phone for daily product use reporting.
9. 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.

Exclusion Criteria

1. 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.
2. 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.
3. Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
4. Has a positive COVID-19 test at Screening or during the study.
5. Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Test Visit 1.
6. Has a fever (\> 100.5°F) at Screening or Test Visit 1.
7. Has a body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
8. 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.
9. 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.
10. Has a post-bronchodilator FEV1 increase ≥ 12% and \> 200 mL from pre- to post-bronchodilator at Screening.
11. 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.
12. Reports use of a very-low nicotine content cigarette (e.g., Moonlight, Spectrum, VLN) as usual brand.
13. 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.
14. 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.
15. Is a self-reported puffer (i.e., draws smoke from the cigarette into the mouth and throat but does not inhale).
16. Is postponing a planned smoking quit attempt in order to participate in the study.
17. Has a history of drug or alcohol abuse within 12 months prior to Screening, as determined by the Investigator.
18. Is allergic to PG or glycerin.
19. Has a positive urine drug or alcohol breath test at Screening or Test Visit 1. At the discretion of the investigator, a subject testing positive for tetrahydrocannabinol may be permitted to participate if the subject reports use by routes other than inhalation.
20. If female, the subject is pregnant, breastfeeding, or intends to become pregnant from Screening through the duration of the study.
21. Has been treated for depression, diabetes, asthma, emphysema, or chronic obstructive pulmonary disease within 12 months prior to Test Visit 1.
22. Has previously been diagnosed with any form of cancer, except for basal cell or squamous epithelial carcinomas of the skin that have been resected at least 12 months prior to Screening 1.
23. Has a planned surgery that would occur during study participation.
24. Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Test Visit 1.
25. Is or has a first-degree relative (e.g., spouse, parent, sibling, or child) who is a current or former employee of a tobacco or ENDS manufacturer or is a named party or class representative in litigation with the tobacco or ENDS industry.
26. Is or has a first-degree relative (e.g., spouse, parent, sibling, or child) who is a current employee of the clinic site.
27. Is or has a first-degree relative (e.g., spouse, parent, sibling, or child) who is a current employee of the Sponsor.
28. Has previously taken part in (from completion of any baseline measurements), has been withdrawn from, or has completed this study.
29. In the opinion of the Investigator, the subject should not participate in this study.

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes