Clinical trial NCT06554873: Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders
Official title: Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Smoking Cessation
Harm Reduction
Lead sponsor: Rose Research Center, LLC
Sponsor class: INDUSTRY
Collaborators: name: Global Action to End Smoking
First posted: 2024-08-15
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 week.
* Cannabis Use Disorder Identification Test-Revised (CUDIT-R) score of 8 or greater.
* Heterosexually active participants 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: vasectomy, vaginal diaphragm with spermicide, intrauterine device, hormonal birth control (oral, injected, or implanted), condom with spermicide, or sponge with spermicide.
* Subgroup enrollment is complete.

Primary outcomes:
measure: Smoking abstinence - CO
timeFrame: Week 12 and Week 24
Secondary outcomes:
measure: Smoking abstinence - Self report of no smoking
timeFrame: Week 12 and Week 24
measure: Reduction in Expired Air CO
timeFrame: Week 12 and Week 24
measure: Usage of Nicotine Products
timeFrame: Week 1 through Week 24, Week 36
measure: Saliva Cotinine Concentrations
timeFrame: Week 12, Week 24, Week 36
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Rose Research Center
state: North Carolina
city: Raleigh
country: United States
facility: Rose Research Center
state: North Carolina
Study officials:
References: