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NCT07099638 · ClinicalTrials.gov registry record · Phase 2
Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation
A Phase 2 study, sponsored by University of Oklahoma.
- Not yet
- Registry status
- Phase 2
- Development phase
- 496
- Enrollment target
NCT07099638 is a Phase 2 study that has not yet begun recruiting, run by University of Oklahoma. The registered enrollment target is 496 participants.
The verdict
NCT07099638, a Phase 2 study, has not yet begun recruiting, sponsored by University of Oklahoma.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 496 participants
- Enrollment target
Study Summary
Although the prevalence of smoking has declined among U.S. adults, smoking remains the leading preventable cause of cancer incidence and mortality. Quitting smoking increases life expectancy, and quitting at an earlier age is associated with more years of life gained. Effective pharmacotherapies to aid cessation are available, and the combination of behavioral support with pharmacotherapy optimizes cessation outcomes. Varenicline is an effective, first-line smoking cessation treatment, and recent research has investigated combination pharmacotherapy to improve the modest quit rates observed with monotherapy. The findings of two meta-analyses have indicated that varenicline combined with the nicotine patch was more effective than varenicline alone for smoking cessation However, 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
Interventions
- BEHAVIORAL Telephone Counseling
- DRUG Varenicline (VAR)
- DRUG Nicotine lozenge (NRT)
- BEHAVIORAL Smartphone intervention with adherence components (ADHERE)
- BEHAVIORAL Smartphone intervention without adherence components (NO ADHERE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2026-05 |
| Est. Completion | 2029-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07099638
The ClinicalTrials.gov registry entry for NCT07099638 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Telephone Counseling is the first listed.
NCT07099638 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07099638 about?
NCT07099638 is a clinical study titled "Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation". Although the prevalence of smoking has declined among U.S. adults, smoking remains the leading preventable cause of cancer incidence and mortality. Quitting smoking increases life expectancy, and quitting at an earlier age is associated with more years of life gained. Effective pharmacotherapies to ...
What is the current status of trial NCT07099638?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 496 participants. The study started on 2026-05. Estimated completion is 2029-06-01.
What interventions are being tested in trial NCT07099638?
The interventions under investigation include: Telephone Counseling (BEHAVIORAL), Varenicline (VAR) (DRUG), Nicotine lozenge (NRT) (DRUG), Smartphone intervention with adherence components (ADHERE) (BEHAVIORAL), Smartphone intervention without adherence components (NO ADHERE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07099638?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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