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

March 25, 2025 updated by: Rose Research Center, LLC

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Rose Research Center
      • Raleigh, North Carolina, United States, 27617
        • Rose Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Planned use of an FDA-approved smoking cessation product during the study, not provided as part of this protocol.
  3. 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.
  4. Taking psychoactive medications (e.g., antipsychotics, benzodiazepines, or mood stabilizers).
  5. Frequent users (monthly) of smokeless tobacco (chewing tobacco, snuff), cigars (not cigarillos), pipes, hookahs or other non-commercially available combustible or heated tobacco products.
  6. Use of nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
  7. Pregnant or nursing (by self-report) or positive pregnancy test.
  8. 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.
  9. Participants who were enrolled in a clinical trial within 30 days of screening.
  10. Enrollment numbers met (in sub-group or entire study).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group I - NRT Responder
Participants 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.
Drug: Nicoderm
21mg nicotine patch daily; maximum usage 9 weeks
Other Names:
  • Nicotine Patch
Drug: Nicorette 4Mg Chewing Gum
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
Other Names:
  • Nicotine gum
Drug: Nicorette Lozenge Product
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
Other Names:
  • Nicotine lozenge
Experimental: Group IIa NRT Non-Responder - Pouch Preferrers
Participants 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.
Drug: Nicoderm
21mg nicotine patch daily; maximum usage 9 weeks
Other Names:
  • Nicotine Patch
Drug: Nicorette 4Mg Chewing Gum
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
Other Names:
  • Nicotine gum
Drug: Nicorette Lozenge Product
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
Other Names:
  • Nicotine lozenge
Other: on!
4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 5 weeks
Other Names:
  • Nicotine pouch
Experimental: Group IIb NRT Non-Responder - Pouch Preferrers Control
Participants 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.
Drug: Nicoderm
21mg nicotine patch daily; maximum usage 9 weeks
Other Names:
  • Nicotine Patch
Drug: Nicorette 4Mg Chewing Gum
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
Other Names:
  • Nicotine gum
Drug: Nicorette Lozenge Product
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
Other Names:
  • Nicotine lozenge
Experimental: Group IIIa NRT Non-Responder - ENDS Preferrers
Participants 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.
Drug: Nicoderm
21mg nicotine patch daily; maximum usage 9 weeks
Other Names:
  • Nicotine Patch
Drug: Nicorette 4Mg Chewing Gum
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
Other Names:
  • Nicotine gum
Drug: Nicorette Lozenge Product
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
Other Names:
  • Nicotine lozenge
Other: BIDI e-cigarette
BIDI e-cigarette (flavors - Classic, Arctic, and Solar); as needed for maximum of 5 weeks
Experimental: Group IIIb NRT Non-Responder - ENDS Preferrers Control
Participants 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.
Drug: Nicoderm
21mg nicotine patch daily; maximum usage 9 weeks
Other Names:
  • Nicotine Patch
Drug: Nicorette 4Mg Chewing Gum
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
Other Names:
  • Nicotine gum
Drug: Nicorette Lozenge Product
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
Other Names:
  • Nicotine lozenge

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in smoke exposure for NRT non-responders
Time Frame: After 10 weeks
Change in expired air CO at week 10 compared to baseline
After 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Smoking abstinence rates for NRT non-responders
Time Frame: Week 7 - Week 10
Complete smoking abstinence defined by a self-report of no cigarette smoking (not even a puff).
Week 7 - Week 10
Smoking abstinence rates for NRT non-responders
Time Frame: Week 7 - Week 10
Complete smoking abstinence defined by expired air CO<6 ppm.
Week 7 - Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rose Research Center, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Foundation for a Smoke Free World INC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Adaptive

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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