The Options 2 Study

University of Wisconsin (UW)

Status and phase: Enrolling; Phase 4

Conditions: Smoker; Smoking Cessation

Treatments: Drug: Mini Nicotine lozenges; Drug: Nicotine Pouches

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06595459

2024-1016

1R01CA291761-01 (U.S. NIH Grant/Contract)

A534253 (Other Identifier)

Protocol Version 8/22/25 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

3mg Nicotine Pouches

Experimental group

Description:

Participants will use 3mg nicotine pouches

Treatment:

Drug: Nicotine Pouches

6mg Nicotine Pouches

Experimental group

Description:

Participants will use 6mg nicotine pouches

Treatment:

Drug: Nicotine Pouches

Nicotine Mini Lozenges

Experimental group

Description:

Participants will use mini lozenges with dosing based on time to first cigarette (2mg - 4mg)

Treatment:

Drug: Mini Nicotine lozenges

No Study Product

No Intervention group

Description:

Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only.