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Smoking CessationPhase 3NCT06088862

Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT

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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will determine whether a range of products along the reduced-risk continuum can reduce smoke exposure for individuals who fail to quit smoking using current medically approved nicotine replacement therapy (NRT) products. 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
4 participants
Where
2 sitesUnited States
Study dates
27 Dec 2023to 30 Apr 2024
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

  • Has signed the Informed Consent From (ICF) and is able to read and understand the information provided in the ICF.
  • Is 22 to 65 years of age (inclusive) at screening.
  • Smokes an average of at least 10 commercially available cigarettes per day and has done so for the last 12 months.
  • Expired air CO reading of at least 10 ppm as assessed at the screening session.
  • Interested in switching to an electronic cigarette or nicotine pouch.
  • Willing and able to comply with the requirements of the study.
  • Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Who cannot join

  • Any participant who has a medical or physical condition that, in the opinion of the investigator (or designee), may adversely affect participant safety, the safety of others, or data validity.
  • Planned use of an FDA-approved smoking cessation product during the study, not provided as part of this protocol.
  • Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.
  • Taking psychoactive medications (e.g., antipsychotics, benzodiazepines, or mood stabilizers).
  • Frequent users (monthly) of smokeless tobacco (chewing tobacco, snuff), cigars (not cigarillos), pipes, hookahs or other non-commercially available combustible or heated tobacco products.
  • Use of nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
Show all 10Show fewer
  • Pregnant or nursing (by self-report) or positive pregnancy test.
  • Heterosexually active participant 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: successful vasectomy of male partner, vaginal diaphragm with spermicide, intrauterine device, hormonal birth control (oral, injected, or implanted), condom with spermicide, or sponge with spermicide.
  • Participants who were enrolled in a clinical trial within 30 days of screening.
  • Enrollment numbers met (in sub-group or entire study).

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

Official title: A Randomized Study to Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With Nicotine Replacement Therapy (NRT)

This study will determine whether a range of products along the reduced-risk continuum can reduce smoke exposure for individuals who fail to quit smoking using current medically approved nicotine replacement therapy (NRT) products. The strategy will be to offer 325 smokers four weeks of NRT of their choice (gum, lozenge, or nicotine patch) and assess them for quit-smoking status at the end of the period. Seven-day point abstinence will be used to determine responder status at the end of the four-week period (CO of <6 ppm at both CO collection points during that seven-day period and self-report of no smoking during that seven-day period). Those who have not quit, and who therefore have a very low chance of later success (a consistent finding in prior studies and to be verified in the proposed study), will be randomly assigned to either receive a potential "rescue" product (nicotine pouch or ENDS (electronic nicotine delivery system), or remain on NRT (control group).

Being tested
Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product, BIDI 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

    21mg nicotine patch daily; maximum usage 9 weeks

  • Nicorette 4Mg Chewing GumDrug

    Also called Nicotine gum

    4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks

  • Nicorette Lozenge ProductDrug

    Also called Nicotine lozenge

    4mg Nicorette mint lozenge; as needed maximum usage 9 weeks

  • BIDI e-cigaretteOther

    BIDI e-cigarette (flavors - Classic, Arctic, and Solar); as needed for maximum of 5 weeks

  • on!Other

    Also called Nicotine pouch

    4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 5 weeks

Study groups in NCT06088862
Study groupRoleWhat they receive
Group I - NRT ResponderExperimentalParticipants that were successful in quitting smoking using NRT in the first four weeks of the study will have the option of remaining on their current NRT or switching to one of the other two options for the next five weeks.
Receives: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product
Group IIa NRT Non-Responder - Pouch PreferrersExperimentalParticipants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try a nicotine pouch. Randomized to be switched to nicotine pouch for the next five weeks.
Receives: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: on!
Group IIb NRT Non-Responder - Pouch Preferrers ControlExperimentalParticipants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try a nicotine pouch. Randomized to be remain on NRT for the next five weeks.
Receives: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product
Group IIIa NRT Non-Responder - ENDS PreferrersExperimentalParticipants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try ENDS. Randomized to be switched to ENDS for the next five weeks.
Receives: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: BIDI e-cigarette
Group IIIb NRT Non-Responder - ENDS Preferrers ControlExperimentalParticipants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try ENDS. Randomized to be remain on NRT for the next five weeks.
Receives: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product

What is being measured

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

  1. Change in smoke exposure for NRT non-responders

    Change in expired air CO at week 10 compared to baseline

    Measured: After 10 weeks

Secondary outcomes (2)

  1. Smoking abstinence rates for NRT non-responders

    Complete smoking abstinence defined by a self-report of no cigarette smoking (not even a puff).

    Measured: Week 7 - Week 10

  2. Smoking abstinence rates for NRT non-responders

    Complete smoking abstinence defined by expired air CO<6 ppm.

    Measured: Week 7 - Week 10

Timeline

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

  1. First posted18 Oct 2023
  2. Study start27 Dec 2023
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Why it stopped: BIDI product received a market denial letter from the FDA

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06088862
Sponsor's protocol ID
Adaptive
Status last verified
Mar 2025
First submitted
12 Oct 2023
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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: stopped early, as of the sponsor's last update on 30 Mar 2025. 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 was stopped early (reason given: BIDI product received a market denial letter from the FDA). Results are not available in the source record.

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?

Change in smoke exposure for NRT non-responders (time frame: After 10 weeks). 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 NCT06088862.

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 30 Mar 2025.

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