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Nicotine Replacement Therapy

Nicotine Responders - Group 1 for Smoking Cessation

Phase 3
Waitlist Available
Research Sponsored by Rose Research Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Healthy, adult smoker of combustible cigarettes.
* Age 22 to 65 years at time of screening (verified by government issued ID).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, week 24, week 36
Awards & highlights

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.

Who is the study for?
This trial is for smokers who have managed to cut their smoking by at least half within two weeks using nicotine products. They should be aiming to maintain this reduction or quit smoking for six months. Specific eligibility criteria are not provided, so general health conditions and other factors that typically exclude participants from clinical trials may apply.
What is being tested?
The study tests if smokers can keep up reduced smoking or stop entirely over six months using nicotine alternatives like patches (Nicoderm), lozenges (Nicorette), e-cigarettes (NJOY), gum (Nicorette Gum), and pouches (on!). It checks the adaptability of these products in maintaining long-term changes in smoking habits.
What are the potential side effects?
Possible side effects might include skin irritation from patches, mouth issues from lozenges and gum, throat irritation from e-cigarettes, and nausea or hiccups from nicotine intake. Individual reactions can vary based on product use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, week 24, week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, week 24, week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Smoking abstinence - CO
Secondary study objectives
Reduction in Expired Air CO
Saliva Cotinine Concentrations
Smoking abstinence - Self report of no smoking
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Nicotine Responders - Group 2Experimental Treatment5 Interventions
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).
Group II: Nicotine Responders - Group 1Experimental Treatment5 Interventions
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).
Group III: Nicotine Non-RespondersExperimental Treatment5 Interventions
Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicoderm
2005
N/A
~30

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Who is running the clinical trial?

Global Action to End SmokingUNKNOWN
Rose Research Center, LLCLead Sponsor
16 Previous Clinical Trials
1,457 Total Patients Enrolled
~100 spots leftby Dec 2025
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