Study Stopped
BIDI product received a market denial letter from the FDA
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)
1 other identifier
interventional
4
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2023
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedMarch 30, 2025
March 1, 2025
4 months
October 12, 2023
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in smoke exposure for NRT non-responders
Change in expired air CO at week 10 compared to baseline
After 10 weeks
Secondary Outcomes (2)
Smoking abstinence rates for NRT non-responders
Week 7 - Week 10
Smoking abstinence rates for NRT non-responders
Week 7 - Week 10
Study Arms (5)
Group I - NRT Responder
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
21mg nicotine patch daily; maximum usage 9 weeks
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
BIDI e-cigarette (flavors - Classic, Arctic, and Solar); as needed for maximum of 5 weeks
4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 5 weeks
Eligibility Criteria
You may qualify if:
- Has signed the Informed Consent From (ICF) and is able to read and understand the information provided in the ICF.
- Is 22 to 65 years of age (inclusive) at screening.
- Smokes an average of at least 10 commercially available cigarettes per day and has done so for the last 12 months.
- Expired air CO reading of at least 10 ppm as assessed at the screening session.
- Interested in switching to an electronic cigarette or nicotine pouch.
- Willing and able to comply with the requirements of the study.
- Owns a smart phone with text message and data capabilities compatible with necessary surveys.
You may not qualify if:
- 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.
- Planned use of an FDA-approved smoking cessation product during the study, not provided as part of this protocol.
- 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.
- Taking psychoactive medications (e.g., antipsychotics, benzodiazepines, or mood stabilizers).
- Frequent users (monthly) of smokeless tobacco (chewing tobacco, snuff), cigars (not cigarillos), pipes, hookahs or other non-commercially available combustible or heated tobacco products.
- Use of nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
- Pregnant or nursing (by self-report) or positive pregnancy test.
- 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.
- Participants who were enrolled in a clinical trial within 30 days of screening.
- Enrollment numbers met (in sub-group or entire study).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rose Research Center, LLClead
- Foundation for a Smoke Free World INCcollaborator
Study Sites (2)
Rose Research Center
Charlotte, North Carolina, 28262, United States
Rose Research Center
Raleigh, North Carolina, 27617, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2023
First Posted
October 18, 2023
Study Start
December 27, 2023
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
March 30, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share