Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Respon… (NCT06554873) | Clinical Trial Compass
CompletedPhase 3
Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders
United States150 participantsStarted 2024-08-29
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
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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 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 the participant, impair the participant's ability to comply with study procedures, or impact the validity of the study results.
* Has used nicotine-containing e-cigarettes (or vapes) or any nicotine replacement therapy (nicotine patch, nicotine gum, nicotine spray, nicotine inhaler, nicotine lozenge) or prescription smoking cessation medications, including, but not limited to, 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 the past year.
* Smokes or vapes cannabis more than once a w…