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

Phase

Condition

Smoking Cessation

Diabetes Prevention

Treatment

Nicorette 4Mg Chewing Gum

on!

Nicoderm

Clinical Study ID

NCT06088862

Adaptive

Ages 22-65
All Genders
Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Has signed the Informed Consent From (ICF) and is able to read and understand theinformation 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 hasdone 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 necessarysurveys.

Exclusion

Exclusion Criteria:

Any participant who has a medical or physical condition that, in the opinion of theinvestigator (or designee), may adversely affect participant safety, the safety ofothers, or data validity.
Planned use of an FDA-approved smoking cessation product during the study, notprovided as part of this protocol.
Coronary heart disease, structural cardiac disease (including, but not limited tovalvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiacchest pain, or history of heart attack or heart failure.
Taking psychoactive medications (e.g., antipsychotics, benzodiazepines, or moodstabilizers).
Frequent users (monthly) of smokeless tobacco (chewing tobacco, snuff), cigars (notcigarillos), pipes, hookahs or other non-commercially available combustible orheated tobacco products.
Use of nicotine replacement therapy or other smoking cessation treatments within 14days of screening.
Pregnant or nursing (by self-report) or positive pregnancy test.
Heterosexually active participant of Childbearing Potential (not sterilized by tuballigation, oophorectomy, hysterectomy, or other surgical methods, or post-menopausal)that do not agree to practice medically appropriate methods of birth control (orremain abstinent) during the course of the trial. Medically acceptable methods ofbirth control include: successful vasectomy of male partner, vaginal diaphragm withspermicide, intrauterine device, hormonal birth control (oral, injected, orimplanted), 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).

Study Design