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OpenTrials
Completed

NCT Number: NCT06554873

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

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.

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Key information

Conditions

Smoking Cessation Behavior Harm Reduction Health Behavior

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rose Research Center, Charlotte, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Nicotine Patch

Nicorette 4Mg Chewing Gum

Drug

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

Other names: Nicotine gum

Nicorette Lozenge Product

Drug

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

Other names: Nicotine lozenge

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.

on!

Other

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

Other names: Nicotine pouch

Primary outcomes

  1. Smoking abstinence - CO

    Time frame: Week 12 and Week 24

    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.

Secondary outcomes

  1. Smoking abstinence - Self report of no smoking

    Time frame: Week 12 and Week 24

    Percent smoking abstinence at 12 weeks and 24 weeks, defined on an intent-to-treat basis as a self-report of no-smoking for the prior 7 days

  2. Reduction in Expired Air CO

    Time frame: Week 12 and Week 24

    Percent of participants achieving a 50% reduction in expired air CO at 12 weeks and 24 weeks relative to baseline.

  3. Usage of Nicotine Products

    Time frame: Week 1 through Week 24, Week 36

    Self-reported usage of nicotine products.

  4. Saliva Cotinine Concentrations

    Time frame: Week 12, Week 24, Week 36

    Saliva cotinine concentrations reflective of nicotine product usage in smoking-abstinent individuals.

Sponsors and collaborators

Lead sponsor

Rose Research Center, LLC

Industry

Collaborators

  • Global Action to End Smoking

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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