The Options 2 Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nicotine Pouches, Mini Nicotine lozenges.
- Who it may be relevant to
- Registry conditions: Smoker, Smoking Cessation. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health
Overview
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
- Drug Nicotine Pouches
nicotine pouches - Drug Mini Nicotine lozenges
mini lozenges
Primary outcome measures
- Mean number of cigarettes smoked per day during the 21-day switching period. [Time frame: Baseline to 3 weeks]
Secondary outcome measures (3)
- Change in cigarette craving [Time frame: Baseline to 3 weeks]
- Mean units of study product used per day during the 7-days prior to the switching period [Time frame: For 7-days leading up to the switching period]
- Mean units of study product used per day during the 21-day of the switching period [Time frame: 21-days of the switching period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Wisconsin — Madison
Identifiers
NCT: NCT06595459 · 2024-1016 · A534253 · Protocol Version 8/22/25 · 1R01CA291761-01