Trials Sponsors Conditions Drugs Pricing

Conditions

Abuse Liability Smoking Behaviors Smoking ( Cigarette)Tobacco Use

Outcome Measures

Primary Outcomes (2)

AUC nic 3-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time 3 to 240 minutes after the start of IP use
3 minutes to 240 minutes
Emax PL
maximum PL VAS score after the start of IP use
240 minutes

Study Arms (2)

Product usage order AB

EXPERIMENTAL

Subjects will use each of the 2 products during an evaluation period, followed by a 4 hour Test Session.

Other: Menthol 5%Other: Combustible cigarette

Product usage order BA

EXPERIMENTAL

Subjects will use each of the 2 products during an evaluation period, followed by a 4 hour Test Session.

Other: Menthol 5%Other: Combustible cigarette

Interventions

Menthol 5%Other

Menthol ENDS 5%

Product usage order ABProduct usage order BA

Combustible cigaretteOther

Usual brand filtered menthol combustible cigarette

Product usage order AB

Eligibility Criteria

Age21 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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 male or female, 21 to 60 years of age, inclusive, at the time of consent.

Sponsors & Collaborators

RAI Services Company
Industrylead

MeSH Terms

Conditions

SmokingCigarette SmokingTobacco Use

Interventions

Menthol

Condition Hierarchy (Ancestors)

BehaviorTobacco Smoking

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexane MonoterpenesCyclohexanes

Study Officials

Milly Kanobe
Reynolds American
STUDY DIRECTOR

Central Study Contacts

Emily Smith

CONTACT

3367412396 smithe13@rjrt.com

Kristen Prevette

CONTACT

3364143176

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

October 13, 2026

First Posted

October 20, 2026

Study Start

November 15, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 2026

Estimated

You may not qualify if:

Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study participant unsuitable to participate in this clinical study.
History, presence of, or clinical laboratory test results indicating diabetes.
Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day -1.
Weight of ≤ 110 pounds (≤ 50.0 kg) at Screening.
Hemoglobin level is \< 12.5 g/dL for females or \<13.0 g/dL for males at Screening.
Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at an investigator's discretion.
Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
Must not be a current regular user (i.e., \> 5 times per month) of any tobacco products other than menthol cigarettes or ENDS within the last 6 months prior to screening.
Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), GLP-1 agonists (e.g., Wegovy®, Mounjaro®, and Ozempic®), or lobelia extract within ≤ 30 days prior to the signing of informed consent.
History or presence of bleeding or clotting disorders.
Use of daily aspirin (≥ 325 mg) or other daily anticoagulants.
Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day -1.
NOTE: Participants will be advised against scheduling a whole blood donation for at least 7 days following study completion.
Plasma donation within ≤ 7 days prior to the signing of informed consent and between Screening and check-in Day -1.
+9 more criteria

A Study to Assess Nicotine Uptake From a Menthol Electronic Nicotine Delivery System Product

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Product usage order AB

Product usage order BA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Product usage order AB

Product usage order BA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record