Recruiting PHASE4 Smoking Cessation

New treatment option for Smoking Cessation

Official title The Avenues Study: Dual Use Cessation

ClinicalTrials.gov ID: NCT06474299

What this study is testing

What is Varenicline?

Varenicline is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for smoking cessation.

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 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.
  • Phase 4: studies an already-approved treatment
  • Time commitment: about 6 months
  • 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

  • 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

You likely can't join if

  • 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...
See the full eligibility criteria
Who can join
  • 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 \>20 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
What rules you out
  • 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...

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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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.