A Phase 3 interventional study of Nicoderm and Nicorette 4Mg Chewing Gum in Smoking Cessation and Harm Reduction, sponsored by Rose Research Center, LLC. Completed at 2 sites in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Rose Research Center, LLC · Phase 3, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's enrollment of 150 is close to the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Rose Research Center, LLC is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
If female, participant is pregnant, nursing, or intends to become pregnant during the time period from screening through the end of study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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!
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!
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!
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
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 24 weeks.
Also known as: Nicotine gum
4mg Nicorette mint lozenge; as needed maximum usage 24 weeks.
Also known as: Nicotine lozenge
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.
4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 24 weeks.
Also known as: Nicotine pouch
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.
Time frame: Week 12 and Week 24
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
Time frame: Week 12 and Week 24
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.
Time frame: Week 12 and Week 24
Usage of Nicotine Products
Self-reported usage of nicotine products.
Time frame: Week 1 through Week 24, Week 36
Saliva Cotinine Concentrations
Saliva cotinine concentrations reflective of nicotine product usage in smoking-abstinent individuals.
Time frame: Week 12, Week 24, Week 36
Ran from Aug 2024 to primary completion in Dec 2025, 15 months.
Of 31 phase 3 interventional studies under Smoking Cessation, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 60. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nicotine Patch
Rose Research Center, LLC