Varenicline with Nicotine Lozenges and a Smartphone App to Help You Stay on Track

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial uses a 2x2 factorial design to compare four groups: varenicline with or without nicotine lozenges, and with or without a smartphone adherence app, all plus counseling. Participants take varenicline for about 13 weeks (including a pre-quit titration) and may use lozenges for 12 weeks. The smartphone app in COMBO-A provides reminders, tracking, and messages around missed doses, while COMBO-B offers a smoking-cessation app without adherence features. Primary outcomes include 7-day point prevalence abstinence at 26 weeks and medication adherence during the 12-week treatment, with daily smoking and adherence monitored via the app and weekly self-report.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to provide documentation of identity (to prevent fraudulent enrollment) and Oklahoma residence (due to limitations on prescribing to out-of-state residents)
* Reports daily smoking ≥5 cigarettes per day
* Provides a breath CO sample ≥6ppm to verify current smoking
* Willing to schedule a smoking cessation attempt within the next 1-2 weeks
* Willing to abstain from smoking cannabis or other combustible products during the study
* Willing to use varenicline and nicotine lozenges
* Willing to participate in the study for ≈6 months
* Able to demonstrate \>6th grade literacy which is necessary to read intervention materials and complete study assessments

Exclusion Criteria:

* Does not own a smartphone that is compatible with the study app
* Using an FDA-approved smoking cessation medication within the past 30 days
* Using oral nicotine products (e.g., pouches, chewing tobacco, snus) more than once per week (5+ times) during the past 30 days
* History of seizures (varenicline contraindication)
* History of allergic reaction to varenicline
* Pregnant, planning to become pregnant, or currently breastfeeding
* Unwilling or unable to use varenicline or nicotine lozenges for other reasons (e.g., severe dry mouth, past history of severe medication side effects)
* Other medical reasons at the discretion of the prescribing physician (e.g., uncontrolled hypertension, recent myocardial infarction)
* Weekly or more frequent use of combustible cannabis during the past 30 days with a score ≥2 on the Cannabis Use Disorder Identification Test-Short Form

Where it's running

• TSET Health Promotion Research Center
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Darla E. Kendzor, Ph.D. — The University of Oklahoma Health Campus
• Study coordinator: Shannon Gwin, Ph.D.
• Email: Shannon-Gwin@ou.edu
• Phone: (405) 271-8001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.