Recruiting PHASE4 Smoker

New treatment option for Smoker

Official title The Options 2 Study

ClinicalTrials.gov ID: NCT06595459

What this study is testing

What is Nicotine Pouches?

Nicotine Pouches is an investigational medicine, given as an once-daily, being studied as a potential treatment for smoker.

Also referred to as ZYN.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 21 and older

You may be able to join if

  • ≥ 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • ≥ 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Madison, Wisconsin, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.