AzTrials
AzTrials

Smoking CessationPhase 3NCT06554873

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

A Phase 3 study testing Nicoderm, Nicorette 4Mg Chewing Gum and Nicorette Lozenge Product in people with Smoking Cessation and Harm Reduction, run by Rose Research Center, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation, Harm Reduction
What is being tested?
Nicoderm, Nicorette 4Mg Chewing Gum and Nicorette Lozenge Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesUnited States
Study dates
29 Aug 2024to 9 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rose Research Center

    Charlotte, North Carolina, 28262

  • Rose Research Center

    Raleigh, North Carolina, 27617

Other trials in United States

About this study

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.

Being tested
Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product, NJOY e-cigarette, on!
Medical subject headings
Smoking Cessation, Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NicodermDrug

    Also called Nicotine Patch

    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.

  • Nicorette 4Mg Chewing GumDrug

    Also called Nicotine gum

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

  • Nicorette Lozenge ProductDrug

    Also called Nicotine lozenge

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

  • NJOY e-cigaretteOther

    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

    Also called Nicotine pouch

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

Study groups in NCT06554873
Study groupRoleWhat they receive
Nicotine Non-RespondersExperimentalParticipants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.
Receives: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: NJOY e-cigarette; Other: on!
Nicotine Responders - Group 1ExperimentalParticipants 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).
Receives: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: NJOY e-cigarette; Other: on!
Nicotine Responders - Group 2ExperimentalParticipants 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).
Receives: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: NJOY e-cigarette; Other: on!

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12 and Week 24

Secondary outcomes (4)

  1. Smoking abstinence - Self report of no smoking

    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

    Measured: Week 12 and Week 24

  2. Reduction in Expired Air CO

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

    Measured: Week 12 and Week 24

  3. Usage of Nicotine Products

    Self-reported usage of nicotine products.

    Measured: Week 1 through Week 24, Week 36

  4. Saliva Cotinine Concentrations

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

    Measured: Week 12, Week 24, Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2024
  2. Study start29 Aug 2024
  3. Primary completion9 Dec 2025
  4. Study completion9 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06554873
Sponsor's protocol ID
ATS2
Status last verified
Feb 2026
First submitted
9 Aug 2024
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicoderm, Nicorette 4Mg Chewing Gum and Nicorette Lozenge Product in people with Smoking Cessation and Harm Reduction, run by Rose Research Center, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking abstinence - CO (time frame: Week 12 and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06554873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in