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

Phase 3

Terminated

• Conditions: Smoking Cessation; Harm Reduction
• Interventions: Drug: Nicoderm; Drug: Nicorette 4Mg Chewing Gum; Drug: Nicorette Lozenge Product; Other: on!; Other: BIDI e-cigarette

• Registration Number: NCT06088862
• Lead Sponsor: Rose Research Center, LLC

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2023-12-27
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I - NRT Responder	Nicorette 4Mg Chewing Gum	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.
Group IIb NRT Non-Responder - Pouch Preferrers Control	Nicorette 4Mg Chewing Gum	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.
Group IIIa NRT Non-Responder - ENDS Preferrers	Nicorette Lozenge Product	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.
Group IIIb NRT Non-Responder - ENDS Preferrers Control	Nicorette 4Mg Chewing Gum	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.
Group I - NRT Responder	Nicorette Lozenge Product	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.
Group IIa NRT Non-Responder - Pouch Preferrers	Nicorette 4Mg Chewing Gum	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.
Group IIIb NRT Non-Responder - ENDS Preferrers Control	Nicorette Lozenge Product	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.
Group IIIb NRT Non-Responder - ENDS Preferrers Control	Nicoderm	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.
Group IIa NRT Non-Responder - Pouch Preferrers	Nicorette Lozenge Product	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.
Group IIIa NRT Non-Responder - ENDS Preferrers	Nicoderm	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.
Group I - NRT Responder	Nicoderm	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.
Group IIb NRT Non-Responder - Pouch Preferrers Control	Nicorette Lozenge Product	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.
Group IIIa NRT Non-Responder - ENDS Preferrers	Nicorette 4Mg Chewing Gum	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.
Group IIa NRT Non-Responder - Pouch Preferrers	on!	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.
Group IIb NRT Non-Responder - Pouch Preferrers Control	Nicoderm	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.
Group IIIa NRT Non-Responder - ENDS Preferrers	BIDI e-cigarette	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.
Group IIa NRT Non-Responder - Pouch Preferrers	Nicoderm	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.

Primary Outcome Measures

Name	Time	Method
Change in smoke exposure for NRT non-responders	After 10 weeks	Change in expired air CO at week 10 compared to baseline

Secondary Outcome Measures

Name	Time	Method
Smoking abstinence rates for NRT non-responders	Week 7 - Week 10	Complete smoking abstinence defined by expired air CO\<6 ppm.

Trial Locations

Locations (1)

Rose Research Center; 🇺🇸 Raleigh, North Carolina, United States