| NCT ID | NCT06595459 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Smoker |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-05-21 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Megan Piper, PhD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT06595459 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Smoker. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06595459 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06595459 currently recruiting?
Yes, NCT06595459 is actively recruiting participants. Contact the research team at mep@ctri.wisc.edu for enrollment information.
Where is the NCT06595459 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT06595459 clinical trial?
NCT06595459 is sponsored by University of Wisconsin, Madison. The principal investigator is Megan Piper, PhD at University of Wisconsin, Madison. The trial plans to enroll 300 participants.