Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders
Phase 3
Active, not recruiting
- Conditions
- Harm ReductionSmoking Cessation
- Interventions
- Other: NJOY e-cigaretteOther: on!
- Registration Number
- NCT06554873
- Lead Sponsor
- Rose Research Center, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nicotine Non-Responders Nicorette Lozenge Product Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study. Nicotine Non-Responders Nicorette 4Mg Chewing Gum Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study. Nicotine Responders - Group 1 Nicorette 4Mg Chewing Gum Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period). Nicotine Responders - Group 1 on! Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period). Nicotine Responders - Group 2 on! Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period). Nicotine Responders - Group 1 Nicorette Lozenge Product Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period). Nicotine Non-Responders NJOY e-cigarette Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study. Nicotine Non-Responders on! Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study. Nicotine Responders - Group 1 Nicoderm Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period). Nicotine Responders - Group 1 NJOY e-cigarette Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period). Nicotine Responders - Group 2 Nicorette Lozenge Product Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period). Nicotine Responders - Group 2 Nicorette 4Mg Chewing Gum Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period). Nicotine Responders - Group 2 NJOY e-cigarette Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period). Nicotine Non-Responders Nicoderm Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study. Nicotine Responders - Group 2 Nicoderm Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).
- Primary Outcome Measures
Name Time Method Smoking abstinence - CO Week 12 and Week 24 To determine whether maintained use of nicotine products can help sustain smoking abstinence rates for early responders. An expired air CO reading of ≤ 5 ppm at 24 weeks.
- Secondary Outcome Measures
Name Time Method Reduction in Expired Air CO Week 12 and Week 24 Percent of participants achieving a 50% reduction in expired air CO at 12 weeks and 24 weeks relative to baseline.
Usage of Nicotine Products Week 1 through Week 24, Week 36 Self-reported usage of nicotine products.
Smoking abstinence - Self report of no smoking Week 12 and Week 24 Percent smoking abstinence at 12 weeks and 24 weeks, defined on an intent-to-treat basis as a self-report of no-smoking for the prior 7 days
Saliva Cotinine Concentrations Week 12, Week 24, Week 36 Saliva cotinine concentrations reflective of nicotine product usage in smoking-abstinent individuals.
Trial Locations
- Locations (1)
Rose Research Center
🇺🇸Raleigh, North Carolina, United States