Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation
Key facts
- Who runs it
- University of Oklahoma
- Where
- Oklahoma City, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 496 people, planned
- Started
- 21 Jul 2026
- Expected to end
- 1 Jun 2029
- Type of study
- Interventional, 4 groups
- Treatments tested
- Varenicline (VAR)
- Nicotine lozenge (NRT)
- Smartphone intervention with adherence components (COMBO-A)
- Smartphone intervention without adherence components (COMBO-B)
- Telephone Counseling
- Record updated
- 9 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Using an FDA-approved smoking cessation medication within the past 30 days
- History of seizures (varenicline contraindication)
- History of allergic reaction to varenicline
- 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
- Does not own a smartphone that is compatible with the study app
- Using oral nicotine products (e.g., pouches, chewing tobacco, snus) more than once per week (5+ times) during the past 30 days
- Pregnant, planning to become pregnant, or currently breastfeeding
Where in United States
- TSET Health Promotion Research CenterOklahoma City, United StatesContact: Shannon Gwin, Ph.D.Taking people
About the trial
What the trial wants to find out
No published studies to date have evaluated the combined impact of varenicline and oral nicotine replacement therapy (NRT) on smoking cessation in a randomized trial. Oral NRT, such as nicotine lozenges, can provide acute relief from cravings/withdrawal, and offers individuals the flexibility to deliver nicotine quickly, in contrast with the continuous, passive, and slow-acting delivery of the nicotine patch. Nevertheless, in clinical trials of other combination pharmacotherapies, participants' adherence to of oral NRT has been suboptimal, making it difficult to determine whether there is an added benefit. Given the near-ubiquity of smartphone ownership (85% of U.S. adults), it is plausible that smartphone-based medication adherence interventions could have a positive influence on pharmacotherapy adherence and smoking cessation. This investigative team has demonstrated the feasibility and potential efficacy of using combination varenicline plus oral NRT treatment to promote smoking cessation in a pilot factorial randomized trial. Likewise, pilot findings showed that medication adherence and smoking cessation rates were higher among those who received smartphone-based medication reminders than those who did not. The proposed study will enroll 496 adults who smoke cigarettes daily. The study will employ a 2x2 factorial design in which participants will be randomized to one of four combinations of two treatment factors: 1) pharmacological treatment (varenicline + nicotine lozenges vs. varenicline alone) and 2) smartphone medication adherence intervention (smartphone-based smoking cessation app with vs. without adherence components). The primary study outcomes will be biochemically-confirmed 7-day point prevalence abstinence at 26 weeks after a scheduled quit date, and medication adherence over the 13-week treatment period. Smartphone-based daily diaries will be employed to assess daily smoking and medication adherence. Notably, the proposed study will employ entirely remote assessment and treatment delivery strategies. Exploratory analyses will evaluate the potential interaction between medication type and the smartphone adherence intervention, and compare the influences of pharmacological treatment type and the medication adherence intervention on weekly physical symptoms (e.g., withdrawal, medication side effects). The overarching goal of the proposed research is to improve smoking cessation treatment and decrease cancer risk.
The 4 groups in the trial
- Varenicline + Smartphone Intervention with adherence components (VAR + COMBO-A)Treatment being tested
Participants will receive 13 weeks of varenicline (1 titration week + 12 weeks at full twice daily 1 mg dosing) and a smartphone-based smoking cessation intervention with medication adherence components. All participants will receive up to 6 telephone counseling calls.
Treatment: Varenicline (VAR), Smartphone intervention with adherence components (COMBO-A), and Telephone Counseling
- Varenicline + Lozenges + Smartphone Intervention with adherence components (VAR + NRT + COMBO-A)Treatment being tested
Participants will receive 13 weeks of varenicline (1 titration week + 12 weeks at full twice daily 1 mg dosing), 12 weeks of nicotine lozenges (2 mg or 4 mg), and a smartphone-based smoking cessation intervention with medication adherence components. All participants will receive up to 6 telephone counseling calls.
Treatment: Varenicline (VAR), Nicotine lozenge (NRT), Smartphone intervention with adherence components (COMBO-A), and Telephone Counseling
- Varenicline + Smartphone Intervention without adherence (VAR + COMBO-B)Treatment being tested
Participants will receive 13 weeks of varenicline (1 titration week + 12 weeks at full twice daily 1 mg dosing) and a smartphone-based smoking cessation intervention without medication adherence components. All participants will receive up to 6 telephone counseling calls.
Treatment: Varenicline (VAR), Smartphone intervention without adherence components (COMBO-B), and Telephone Counseling
- Varenicline + Lozenges + Smartphone Intervention without adherence (VAR + NRT + COMBO-B)Treatment being tested
Participants will receive 13 weeks of varenicline (1 titration week + 12 weeks at full twice daily 1 mg dosing), 12 weeks of nicotine lozenges (2 mg or 4 mg), and a smartphone-based smoking cessation intervention without medication adherence components. All participants will receive up to 6 telephone counseling calls.
Treatment: Varenicline (VAR), Nicotine lozenge (NRT), Smartphone intervention without adherence components (COMBO-B), and Telephone Counseling
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Factorial Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention to Promote Smoking Cessation
- Record updated
- 9 November 2026