Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders

Phase

Condition

Diabetes Prevention

Smoking Cessation

Treatment

Nicoderm

NJOY e-cigarette

on!

Clinical Study ID

NCT06554873

ATS2

Ages 22-65
All Genders
Accepts Healthy Volunteers

Study Summary

To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Healthy, adult smoker of combustible cigarettes.
Age 22 to 65 years at time of screening (verified by government issued ID).
Smoke cigarettes for ≥12 months prior to screening.
Currently smokes at least 10 tobacco cigarettes per day.
Screening eCO ≥ 10 ppm.
Voluntarily provides consent for participation by signing the informed consent form (ICF).
Willing and able to comply with study requirements.

Exclusion

Exclusion Criteria:

Unable to read, speak or understand English
Has a history or presence of clinically significant medical or psychiatric disease,or any other condition that would in the PI's judgement jeopardize the safety of theparticipant, impair the participant's ability to comply with study procedures, orimpact the validity of the study results.
Has used nicotine-containing e-cigarettes (or vapes) or any nicotine replacementtherapy (nicotine patch, nicotine gum, nicotine spray, nicotine inhaler, nicotinelozenge) or prescription smoking cessation medications, including, but not limitedto, varenicline (Chantix*) or bupropion (Zyban®) within the past 30 days.

If female, participant is pregnant, nursing, or intends to become pregnant during the time period from screening through the end of study.

Has participated in a research study about tobacco products or ENDS within the past 30 days.
Has participated in a smoking cessation or nicotine switching research study in thepast year.
Smokes or vapes cannabis more than once a week.
Cannabis Use Disorder Identification Test-Revised (CUDIT-R) score of 8 or greater.
Heterosexually active participants of Childbearing Potential (not sterilized bytubal ligation, oophorectomy, hysterectomy, or other surgical methods, orpost-menopausal) that do not agree to practice medically appropriate methods ofbirth control (or remain abstinent) during the course of the trial. Medicallyacceptable methods of birth control include: vasectomy, vaginal diaphragm withspermicide, intrauterine device, hormonal birth control (oral, injected, orimplanted), condom with spermicide, or sponge with spermicide.
Subgroup enrollment is complete.

Study Design