Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders

NCT06554873 | Completed Phase 3 FDA Drug

• 1 other identifier: ATS2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence.

Conditions

Harm Reduction; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Smoking abstinence - CO

  To determine whether maintained use of nicotine products can help sustain smoking abstinence rates for early responders. An expired air CO reading of ≤ 5 ppm at 24 weeks.

  Week 12 and Week 24

Secondary Outcomes (4)

• Smoking abstinence - Self report of no smoking

  Week 12 and Week 24

• Reduction in Expired Air CO

  Week 12 and Week 24

• Usage of Nicotine Products

  Week 1 through Week 24, Week 36

• Saliva Cotinine Concentrations

  Week 12, Week 24, Week 36

Study Arms (3)

Nicotine Non-Responders

EXPERIMENTAL

Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.

Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: NJOY e-cigarette; Other: on!

Nicotine Responders - Group 1

EXPERIMENTAL

Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period).

Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: NJOY e-cigarette; Other: on!

Nicotine Responders - Group 2

EXPERIMENTAL

Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).

Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: NJOY e-cigarette; Other: on!

Interventions

Nicorette 4Mg Chewing Gum DRUG

4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 24 weeks.

Also known as: Nicotine gum

Nicotine Non-Responders; Nicotine Responders - Group 1; Nicotine Responders - Group 2

Nicorette Lozenge Product DRUG

4mg Nicorette mint lozenge; as needed maximum usage 24 weeks.

Also known as: Nicotine lozenge

Nicotine Non-Responders; Nicotine Responders - Group 1; Nicotine Responders - Group 2

NJOY e-cigarette OTHER

Each NJOY Classic Tobacco and Menthol pod is pre-filled with 1.9 mL of e-liquid with 5% nicotine (by weight); as needed maximum usage 24 weeks.

Nicotine Non-Responders; Nicotine Responders - Group 1; Nicotine Responders - Group 2

on! OTHER

4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 24 weeks.

Also known as: Nicotine pouch

Nicotine Non-Responders; Nicotine Responders - Group 1; Nicotine Responders - Group 2

Nicoderm DRUG

Depending on responder status and group assignment the maximum amount of time nicotine patches will be used is 24 weeks. The final four weeks of nicotine patch treatment will comprise 2 weeks of 14 mg patches and two weeks of 7 mg patches.

Also known as: Nicotine Patch

Nicotine Non-Responders; Nicotine Responders - Group 1; Nicotine Responders - Group 2

Eligibility Criteria

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

You may qualify if:

• Healthy, adult smoker of combustible cigarettes.
• Age 22 to 65 years at time of screening (verified by government issued ID).
• Smoke cigarettes for ≥12 months prior to screening.
• Currently smokes at least 10 tobacco cigarettes per day.
• Screening eCO ≥ 10 ppm.
• Voluntarily provides consent for participation by signing the informed consent form (ICF).
• Willing and able to comply with study requirements.

You may not qualify if:

• Unable to read, speak or understand English
• Has a history or presence of clinically significant medical or psychiatric disease, or any other condition that would in the PI's judgement jeopardize the safety of the participant, impair the participant's ability to comply with study procedures, or impact the validity of the study results.
• Has used nicotine-containing e-cigarettes (or vapes) or any nicotine replacement therapy (nicotine patch, nicotine gum, nicotine spray, nicotine inhaler, nicotine lozenge) or prescription smoking cessation medications, including, but not limited to, varenicline (Chantix\*) or bupropion (Zyban®) within the past 30 days.
• If female, participant is pregnant, nursing, or intends to become pregnant during the time period from screening through the end of study.
• Has participated in a research study about tobacco products or ENDS within the past 30 days.
• Has participated in a smoking cessation or nicotine switching research study in the past year.
• Smokes or vapes cannabis more than once a week.
• Cannabis Use Disorder Identification Test-Revised (CUDIT-R) score of 8 or greater.
• Heterosexually active participants of Childbearing Potential (not sterilized by tubal ligation, oophorectomy, hysterectomy, or other surgical methods, or post-menopausal) that do not agree to practice medically appropriate methods of birth control (or remain abstinent) during the course of the trial. Medically acceptable methods of birth control include: vasectomy, vaginal diaphragm with spermicide, intrauterine device, hormonal birth control (oral, injected, or implanted), condom with spermicide, or sponge with spermicide.
• Subgroup enrollment is complete.

Sponsors & Collaborators

• Global Action to End Smoking: collaborator
• Rose Research Center, LLC: lead

Study Sites (2)

Rose Research Center

Charlotte, North Carolina, 28262, United States

Location

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Harm Reduction

Interventions

Nicotine; Tobacco Use Cessation Devices; Nicotine Chewing Gum; Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Exudates; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 15, 2024
• Study Start: August 29, 2024
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (2)