Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation

Launched by UNIVERSITY OF OKLAHOMA · Jul 25, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new way to help people quit smoking by combining two types of treatments: a medication called varenicline and nicotine lozenges, which are small tablets that slowly release nicotine to reduce cravings. The study also looks at whether using a smartphone app that reminds and supports people to take their medication can improve quitting success. Researchers want to see if this combination of treatments and the app can help more people stop smoking compared to using varenicline alone or without the app.

Adults who smoke at least five cigarettes a day, live in Oklahoma, and are ready to try quitting within the next couple of weeks may be eligible to join. Participants need to be willing to use the medications and avoid smoking other products like cannabis during the study. The study lasts about six months and is done completely remotely, so people can take part from home. Throughout the study, participants will report daily on their smoking and medication use through their phone. The main goal is to find out how many people remain smoke-free after six months and how well they stick to their medication plan. This research hopes to improve quitting methods and reduce the risk of cancer caused by smoking.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1) Able to provide documentation of identity (to prevent fraudulent enrollment) and Oklahoma residence (due to limitations on prescribing to out-of-state residents), 2) report daily smoking ≥5 cigarettes per day, 3) provide a breath CO sample ≥6ppm to verify current smoking, 4) are willing to schedule a smoking cessation attempt within the next 1-2 weeks, 5) are willing to abstain from smoking cannabis or other combustible products during the study, 6) are willing to use varenicline and nicotine lozenges, 7) are willing to participate in the study for ≈6 months, and 8) are able to demonstrate \>6th grade literacy which is necessary to read intervention materials and complete study assessments
• Exclusion Criteria:
• • 1) History of seizures (varenicline contraindication), 2) history of allergic reaction to varenicline, 2) are pregnant, planning to become pregnant, or currently breastfeeding, 3) are unwilling or unable to use varenicline or nicotine lozenges for other reasons (e.g., severe dry mouth, past history of severe medication side effects), 4) other medical reasons at the discretion of the prescribing physician (e.g., uncontrolled hypertension, recent myocardial infarction), or 5) 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