Smoker, Smoking Cessation
Conditions
Brief summary
The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products. Participants will: * Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks. * Have 6 in-person research visits and 1 follow-up call * Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use
Detailed description
Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effectively they can substitute for cigarettes when smokers are trying to avoid smoking, the role of nicotine dose in the ability of pouches to serve as a substitute, or the mechanisms that facilitate or hinder successful product transition. This study will address these questions using a 4-arm randomized controlled trial of adults who smoke ≥5 cigarettes daily and are not planning to quit smoking in the next 30 days. This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes. The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions.
Interventions
DRUGNicotine Pouches
nicotine pouches
DRUGMini Nicotine lozenges
mini lozenges
Sponsors
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 21 years old (i.e., able to legally purchase tobacco products) * able to read and communicate in English * no plans to quit smoking in the next 30 days * willing to stop using nicotine replacement or varenicline * willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation * smoking ≥ 5 cigarettes per day for the past 6 months * exhaled carbon monoxide ≥ 6 ppm * no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months
Exclusion criteria
* currently in treatment for psychosis or bipolar disorder * currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression) * currently pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of cigarettes smoked per day during the 21-day switching period. | Baseline to 3 weeks | Participants will self-report on their cigarette use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cigarette craving | Baseline to 3 weeks | Participants will rate their craving for a cigarette using a 0-100 visual analog scale, where 0 = no craving and 100 = extreme craving after sampling their assigned study product after overnight abstinence from smoking |
| Mean units of study product used per day during the 7-days prior to the switching period | For 7-days leading up to the switching period | Participants will report their study product use via EMA |
| Mean units of study product used per day during the 21-day of the switching period | 21-days of the switching period | Participants will report their study product use via EMA |
Countries
United States
Contacts
CONTACTMegan Piper, PhD
CONTACTMark Zehner
PRINCIPAL_INVESTIGATORMegan Piper, PhD
University of Wisconsin, Madison
Outcome results
None listed