Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches

NCT05664672 | Completed Results

• 1 other identifier: ALCS-REG-20-15-OTDN
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on!® NPs. The study intends to determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who completely switch from smoking to use of on!® NP compared to those who continue smoking cigarettes or stop using all tobacco products.

Conditions

Tobacco Use

Keywords

Tobacco; Smoking

Outcome Measures

Primary Outcomes (1)

• NNAL Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days

  Summary of 24-hour urinary creatinine-adjusted total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in subjects using nicotine pouches (NP) for 7 days versus subjects who continue to smoke cigarettes for 7 days and subjects who stopped using any tobacco products for 7 days. Total urine weight (g) collected during 24 hours was converted to 24-hour urine volume using assumed density of 1 g = 1 mL Amount of biomarker was calculated as: Urine Biomarker (unit2/24 hours) = Urine biomarker concentration \[unit1/mL\] × 24h urine volume \[mL\] ÷ 1000, where: unit2 = ng if unit1 = pg; unit2 = μg if unit1 = ng Adjusted Urine biomarker (unit2/g creatinine) = Urine biomarker concentration (unit1/mL) × 100 / Creatinine concentration (mg/dL), where unit2 = ng if unit1 = pg, and unit2 = μg if unit 1 = ng The absolute change from baseline of urine biomarker amount excreted in 24 hours was calculated as follows: Absolute change from baseline = Post Randomization Value - Baseline Value

  Samples collected over 24 hours on Day -1 (baseline) and Day 7

Secondary Outcomes (23)

• NE Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days

  Samples collected over 24 hours on Day -1 (baseline) and Day 7

• 2-AN Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days

  Samples collected over 24 hours on Day -1 (baseline) and Day 7

• 4-ABP Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days

  Samples collected over 24 hours on Day -1 (baseline) and Day 7

• HEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days

  Samples collected over 24 hours on Day -1 (baseline) and Day 7

• CEMA Exposure in Subjects Using Nicotine Pouches for 7 Days Versus Subjects Who Continue to Smoke Cigarettes for 7 Days

  Samples collected over 24 hours on Day -1 (baseline) and Day 7

Study Arms (5)

Group 1 (CC)

NO INTERVENTION

Subjects will be asked to continue smoking their UBCs ad libitum for 7 days.

Group 2 (NP2)

EXPERIMENTAL

Subjects will exclusively use 2 mg NP, using at least 3 pouches per day for 7 days.

Other: OTDN Product 1

Group 3 (NP4)

EXPERIMENTAL

Subjects will exclusively use 4 mg NP, using at least 3 pouches per day for 7 days.

Other: OTDN Product 2

Group 4 (NP8)

EXPERIMENTAL

Subjects will exclusively use 8 mg NP, using at least 3 pouches per day for 7 days.

Other: OTDN Product 3

Group 5 (NT)

EXPERIMENTAL

Subjects will completely stop all tobacco product usage for 7 days.

Other: No Tobacco

Interventions

OTDN Product 1 OTHER

Mint on!® 2 mg nicotine pouches

Group 2 (NP2)

OTDN Product 2 OTHER

Mint on!® 4 mg nicotine pouches

Group 3 (NP4)

OTDN Product 3 OTHER

Mint on!® 8 mg nicotine pouches

Group 4 (NP8)

No Tobacco OTHER

subjects completely stop all tobacco product usage for 7 days

Group 5 (NT)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Not more than 60% of either gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary consent to participate in this study documented on the signed ICF
• Smoking history (self-reported at screening) of an average of at least 10 but no more than 30 factory-manufactured combustible cigarettes (either menthol or non-menthol) daily for at least 12 months prior to screening. Brief periods (ie, up to 7 consecutive days) of non-smoking during the 3 months prior to screening (eg, due to illness or participation in a study where smoking was prohibited) will be permitted
• Positive urine cotinine (≥ 500 ng/mL) at screening
• Female subjects who are heterosexually active and of childbearing potential (eg, neither surgically sterile at least 6 months prior to check-in nor postmenopausal with amenorrhea for at least 12 months prior to check-in with follicle-stimulating hormone \[FSH\] levels consistent with postmenopausal status) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
• Hormonal (eg, oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to check-in, double barrier (ie, condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to check-in, an intrauterine device for at least 4 months prior to check-in
• Exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to check-in
• Female subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study.
• Female subjects who are of nonchildbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to check-in:
• Hysteroscopic sterilization (including Essure® or similar nonsurgical sterilization procedures); bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomy
• Or be postmenopausal with amenorrhea for at least 12 months prior to check-in and have FSH levels consistent with postmenopausal status
• Willing to comply with the requirements of the study
• Willing to use all 3 on!® NP after the Product Trial at check-in
• Willing and able to abstain from cigarettes from Day 1 through the end of the study (EOS)
• Healthy adult males and females, 21 to 65 years of age, inclusive at screening, with subjects aged 46 to 65 years being fully vaccinated for COVID-19 (SARS-CoV-2) at least 14 days before the screening visit.

You may not qualify if:

• Use of any type of tobacco- or nicotine-containing products other than manufactured cigarettes (eg, e-vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) in the 7 days prior to check-in
• Self-reported puffers (ie, adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale)
• Planning to quit smoking in the next 30 days (from screening visit)
• History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory diseases, immunologic, psychiatric, lymphatic, 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
• Clinically significant abnormal findings on the vital signs, physical examination, medical history, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the investigator
• Positive test for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at screening
• History or presence of any type of malignant tumors
• Current evidence or any history of congestive heart failure
• Diabetes mellitus (fasting glucose ≥126 mg/L \[7 mmol/L\]) that is not controlled by diet/exercise alone, in the opinion of the investigator
• An acute illness (eg, upper respiratory infection, viral infection) requiring treatment with prescribed medicines within 2 weeks prior to check-in
• Dentition that prevents subjects from using on!® NP products
• Allergic to or cannot tolerate mint flavoring agents or phenylalanine
• Any planned surgery from the time of screening through EOS
• History of drug or alcohol abuse within 24 months prior to check-in
• Fever (ie, body temperature \>100.5°F) at screening or check-in. One recheck may be performed at the investigator's discretion

Sponsors & Collaborators

• Altria Client Services LLC: lead
• Covance: collaborator

Study Sites (3)

CKRA

Lexington, Kentucky, 40509, United States

Location

QPS

Springfield, Missouri, 65802, United States

Location

NOCCR

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Tobacco Use; Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Functional Director Clinical Research
• Organization: Altria

Jeffery.S.Edmiston@altria.com

8043352366

Study Officials

• William J Howitt, MD

  QPS Holdings LLC

  PRINCIPAL INVESTIGATOR

• William Smith, MD

  NOCCR

  PRINCIPAL INVESTIGATOR

• Mark Adams, MD

  CKRA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: May 11, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)