Status:
TERMINATED
Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT
Lead Sponsor:
Rose Research Center, LLC
Collaborating Sponsors:
Foundation for a Smoke Free World INC
Conditions:
Smoking Cessation
Harm Reduction
Eligibility:
All Genders
22-65 years
Phase:
PHASE3
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 repl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06088862
Start Date
December 27 2023
End Date
April 30 2024
Last Update
March 30 2025
Active Locations (2)
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1
Rose Research Center
Charlotte, North Carolina, United States, 28262
2
Rose Research Center
Raleigh, North Carolina, United States, 27617