NCT06474299 The Avenues Study: Dual Use Cessation
| NCT ID | NCT06474299 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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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 500 participants in total. It began in 2024-09-24 with a primary completion date of 2028-07.
⚠ 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 overarching goal of this research is to determine the most effective approach for helping dual users of cigarettes and electronic nicotine delivery systems (ENDS) quit smoking. 500 participants will be enrolled and can expect to be on study for 12 months.
Eligibility Criteria
Inclusion Criteria: * Able to read and communicate in English * Willing to set a quit date to quit smoking cigarettes in the next 30 days * Willing and medically able to use varenicline and nicotine patches * Smoking ≥ 5 cigarettes per day for the past 6 months * Vaping weekly for at least 6 months * 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 * Saliva cotinine \>30 ng/ml * US resident * Own a Smartphone to use and download an app to record data * have a working email so that they can receive links for video visits Exclusion Criteria: * Currently in treatment for psychosis or bipolar disorder * If they are currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression) * Currently pregnant or breastfeeding. If a participant becomes pregnant while in the study, they will be allowed to continue in the study but will no longer receive study medications. They will also be asked to return any unused study medications.
Contact & Investigator
Megan E Piper, PhD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT06474299 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Smoking Cessation. 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 NCT06474299 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 NCT06474299 currently recruiting?
Yes, NCT06474299 is actively recruiting participants. Contact the research team at mark.zehner@wisc.edu for enrollment information.
Where is the NCT06474299 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT06474299 clinical trial?
NCT06474299 is sponsored by University of Wisconsin, Madison. The principal investigator is Megan E Piper, PhD at University of Wisconsin, Madison. The trial plans to enroll 500 participants.