The Options 2 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-21

Study Completion Date

2029-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparisons of Nicotine-free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine

NCT00777569

Tobacco Dependence

COMPLETED PHASE2

Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

NCT02355665

Tobacco Dependence

COMPLETED PHASE3

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

NCT00710034

Tobacco Use Disorder

COMPLETED PHASE2

Use of Nicotine Pouches Among Daily Smokers

NCT06043362

Tobacco Dependence

RECRUITING NA

Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II

NCT00734617

Cigarette Smoking

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoker Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3mg Nicotine Pouches

Participants will use 3mg nicotine pouches

Group Type EXPERIMENTAL

Nicotine Pouches

Intervention Type DRUG

3mg or 6mg nicotine pouches

6mg Nicotine Pouches

Participants will use 6mg nicotine pouches

Group Type EXPERIMENTAL

Nicotine Pouches

Intervention Type DRUG

3mg or 6mg nicotine pouches

Nicotine Mini Lozenges

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

Group Type EXPERIMENTAL

Mini Nicotine lozenges

Intervention Type DRUG

2mg to 4mg mini lozenges

No Study Product

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotine Pouches

3mg or 6mg nicotine pouches

Intervention Type DRUG

Mini Nicotine lozenges

2mg to 4mg mini lozenges

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ZYN

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No