The Options 2 Study

Phase 4

Recruiting

• Conditions: Smoker; Smoking Cessation
• Interventions: Drug: Nicotine Pouches; Drug: Mini Nicotine lozenges

• Registration Number: NCT06595459
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2025-05
• Study Start: 2025-05-21
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3mg Nicotine Pouches	Nicotine Pouches	Participants will use 3mg nicotine pouches
6mg Nicotine Pouches	Nicotine Pouches	Participants will use 6mg nicotine pouches
Nicotine Mini Lozenges	Mini Nicotine lozenges	Participants will use mini lozenges with dosing based on time to first cigarette (2mg - 4mg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States