A Multi Site, Open Label, Parallel Group Study to Assess Changes in Tobacco Related Biomarkers of Exposure Following Switching From Smoking of Combustible Cigarettes to Exclusive Use of Nicotine Pouches in Adult Smokers

RAI Services Company5 sites in 1 country200 target enrollmentAugust 22, 2024

ConditionsTobacco Use Smoking

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tobacco Use
Sponsor: RAI Services Company
Enrollment: 200
Locations: 5
Primary Endpoint: 4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL]
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.

Registry

clinicaltrials.gov

Start Date

August 22, 2024

End Date

January 15, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

RAI Services Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to read, understand, and be willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
•Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
•Smokes combustible, filtered, nonmenthol or menthol cigarettes, 83 mm to 100 mm in length.
•Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke for at least six months prior to Screening. Brief periods of abstinence due to illness, a quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the PI.
•Self-reports that cigarettes are their primary tobacco- or nicotine-containing product use within 30 days of Screening. (Note: occasional use of other tobacco- or nicotine-containing products may be acceptable in consultation with the Sponsor);
•Agrees to use assigned IP throughout the study period.
•Expired breath carbon monoxide (ECO) level ≥ 10 ppm and ≤ 100 ppm at Screening and at CheckIn on Day
•Positive urine cotinine test at Screening.
•Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "630 minutes." (Heatherton, Kozlowski, Frecker, \& Fagerstrom, 1991).
•Willing to switch from current UB cigarette to either nicotine Pouch IP, or abstain from smoking, for approximately 5 days during in-clinic confinement;

Exclusion Criteria

•The 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 the PI, makes the subject unsuitable to participate in this clinical study.
•History, presence of, or clinical laboratory test results indicating diabetes. Fasting plasma glucose \> 126 mg/dL (7 mmol/L) is exclusionary. One recheck may be performed for fasting plasma glucose values \> 126 mg/dL but \< 200 mg/dL.
•Scheduled treatment for asthma currently or within the past 12 consecutive months prior to Screening. As needed treatment, such as inhalers, may be included at the PI's discretion, pending approval from the Medical Monitor.
•Use of any medications that interfere with the cyclooxygenase pathway (e.g., antiinflammatoryanti-inflammatory drugs such as aspirin and ibuprofen) 14 days prior to CheckIn on Day
•Use of medications or substances (other than nicotine) known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 halflives of the medication or substances (whichever is longer) prior to CheckIn on Day
•History or presence of bleeding or clotting disorders.
•Any history of cancer, except for primary cancers of the skin, such as localized basal cell/squamous cell carcinoma, that have been surgically and/or cryogenically removed.
•Systolic blood pressure (BP) of \> 160 mmHg or a diastolic BP of \> 95 mmHg, measured after being seated for 5 minutes at Screening and CheckIn on Day
•Body Mass Index (BMI) \< 18.0 or \>40.0 kg/m2 (weight of ≤ 110 pounds) at Screening.
•Hemoglobin level \< 12.5 g/dL for females or \<13.0 g/dL for males at Screening.

Outcomes

Primary Outcomes

4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL]

Time Frame: 24 hour

Secondary Outcomes

1Aminonaphthalene [1AN](24 hour)
3Hydroxy1methylpropylmercapturic acid [HMPMA](24 hour)
3hydroxybenzo[a]pyrene [3-OH-B[a]P](24 hour)
SPhenyl mercapturic acid [SPMA](24 hour)
4Aminobiphenyl [4ABP](24 hour)
Carboxyhemoglobin [COHb](12 hour)
2Cyanoethyl mercapturic acid [CEMA](24 hour)
2Aminonaphthalene [2AN](24 hour)
3Hydroxypropyl mercapturic acid [3HPMA](24 hour)
1hydroxypyrene [1OHP](24 hour)
Monohydroxybutyl mercapturic acid [MHBMA](24 hour)
Nnitrosonornicotine [NNN] + glucuronides [Total NNN](12 hour)
Total nicotine equivalents (molar sum of nicotine, cotinine, 3hydroxycotinine and their glucuronides) [TNneq](24 hour)