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

Study acronym: COMBOII
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
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Record History

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  1. Primary endpoint(s) modifiedv8 Show 7 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Sep 2026 to Jul 21, 2026
    • Interventions: Nicotine lozenge (NRT) (Drug), Smartphone intervention with adherence components (ADHERE) (Behavioral), Smartphone intervention without… to Nicotine lozenge (NRT) (Drug), Smartphone intervention with adherence components (COMBO-A) (Behavioral), Smartphone intervention without…
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 3 to 2
    • Study description shortened, about 49 words
    • Site details revised
  2. Start date: May 2026 to Sep 2026v7
  3. Start date: Mar 2026 to May 2026v6
  4. Start date: Jan 5, 2026 to Mar 2026
    • Collaborators: 5 to 4
    v5
  5. Primary and study completion dates: Jun 2029 to Jun 1, 2029
    • Start date: Jan 2026 to Jan 5, 2026
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Oct 2025 to Jan 2026v3
  2. Eligibility criteria shortened, about 23 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site contact updated
    • Collaborators revised (5)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07099638
Lead Sponsor University of Oklahoma
Collaborators: National Cancer Institute (NCI), Brown University, Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Conditions
(from sponsor)		 Smoking Cessation
Related terms Medication Adherence, Smoking Cessation
Enrollment 496 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov