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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06088862
Other study ID # Adaptive
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 27, 2023
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Rose Research Center, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 325
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Nicoderm
21mg nicotine patch daily; maximum usage 9 weeks
Nicorette 4Mg Chewing Gum
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
Nicorette Lozenge Product
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
Other:
BIDI e-cigarette
BIDI e-cigarette (flavors - Classic, Arctic, and Solar); as needed for maximum of 5 weeks
on!
4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 5 weeks

Locations

Country Name City State
United States Rose Research Center Charlotte North Carolina
United States Rose Research Center Raleigh North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Rose Research Center, LLC Foundation for a Smoke Free World INC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in smoke exposure for NRT non-responders Change in expired air CO at week 10 compared to baseline After 10 weeks
Secondary 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
Secondary Smoking abstinence rates for NRT non-responders Complete smoking abstinence defined by expired air CO<6 ppm. Week 7 - Week 10
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