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

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: Active, not recruiting
• Conditions: Smoking Cessation; Harm Reduction
• Intervention / Treatment: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: on!; Other: BIDI e-cigarette

• Study Type: Interventional
• Enrollment (Estimated): 325
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in smoke exposure for NRT non-responders	Change in expired air CO at week 10 compared to baseline	After 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking abstinence rates for NRT non-responders	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	Complete smoking abstinence defined by expired air CO<6 ppm.	Week 7 - Week 10

Collaborators and Investigators

• Sponsor: Rose Research Center, LLC
• Collaborators: Foundation for a Smoke Free World INC

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID 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