Recruiting
Phase 2

Varenicline & NRT

Sponsor:

University of Oklahoma

Code:

NCT07099638

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Varenicline (VAR)

Nicotine lozenge (NRT)

Smartphone intervention with adherence components (COMBO-A)

Smartphone intervention without adherence components (COMBO-B)

Telephone Counseling

Study Details

Brief summary:

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.

Conditions

Smoking Cessation

Study ID

NCT07099638

Start date

Jul 21, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

496 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Varenicline + Smartphone Intervention with adherence components (VAR + COMBO-A)

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.

experimental: Varenicline + Lozenges + Smartphone Intervention with adherence components (VAR + NRT + COMBO-A)

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.

experimental: Varenicline + Smartphone Intervention without adherence (VAR + COMBO-B)

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.

experimental: Varenicline + Lozenges + Smartphone Intervention without adherence (VAR + NRT + COMBO-B)

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.

Interventions

Varenicline (VAR)

13 weeks of varenicline

Nicotine lozenge (NRT)

12 weeks of nicotine lozenges

Smartphone intervention with adherence components (COMBO-A)

Smartphone-based smoking cessation intervention with adherence components

Smartphone intervention without adherence components (COMBO-B)

Smartphone-based smoking cessation intervention without adherence components

Telephone Counseling

Up to 6 telephone counseling sessions with a tobacco treatment specialist

Primary outcome measure

  • Smoking Abstinence (26 weeks post-quit) [ Time Frame: 26 weeks after the scheduled quit day ]
  • Medication Adherence (weekly) [ Time Frame: Weekly starting on the quit day (for varenicline) or 1-week post-quit (for lozenges) through 12 weeks post-quit. ]

Central Contacts and Locations

Central contacts

Shannon Gwin, Ph.D.

(405) 271-8001Shannon-Gwin@ou.edu

Sharon Glassman

(405) 271-8001Sharon-Glassman@ou.edu

Locations

TSET Health Promotion Research Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Shannon Gwin, Ph.D.

405-271-8001Shannon-Gwin@ou.edu

Sharon Glassman

(405) 271-8001Sharon-Glassman@ou.edu

Principal Investigator:

Darla E. Kendzor, Ph.D.

More Information

Sponsor

University of Oklahoma

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Smoking Cessation
  • Varenicline
  • Nicotine Lozenges
  • Medication Adherence
  • Smartphone Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-08-19.