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NCT03722966 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
A Phase 2 study, sponsored by University of Oklahoma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT03722966 is a Phase 2 study that was terminated before completion, run by University of Oklahoma. The registered enrollment target is 34 participants.
The verdict
NCT03722966, a Phase 2 study, was terminated before completion, sponsored by University of Oklahoma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Varenicline is considered to be a first-line tobacco cessation treatment. Previous studies have evaluated the impact of the combination of varenicline and nicotine patches (versus varenicline alone) on smoking cessation, though findings have been equivocal. No studies to date have evaluated the combination of varenicline and oral nicotine replacement therapy (NRT; i.e., nicotine lozenges or gum). Nicotine lozenges and gum can provide acute relief during cravings and high risk situations, which offers individuals the flexibility to deliver nicotine when they need it most (in contrast with the continuous and passive delivery of nicotine offered via the patch). Prospective clinical trials are needed in real-world settings to determine whether the combination of varenicline and oral nicotine replacement therapy (i.e., lozenges, gum) is superior to varenicline alone for smoking cessation. The proposed pilot randomized trial would enroll 100 participants over 1 year (≈8 participants per month) utilizing a 2x2 factorial design. Twelve weeks of a pharmacological intervention \[varenicline + oral NRT (VAR+N) vs. varenicline alone (VAR)\] will be crossed with automated medication reminders (reminder messages vs. no reminder messages). All participants will receive an adapted version of the standard counseling offered through the Tobacco Treatment Research Program (TTRP). The primary outcomes will be biochemically-verified smoking cessation at 12 and 26 weeks following a scheduled quit attempt (1 week after enrollment). Smartphone-based ecological momentary assessment (EMA) will be employed to measure withdrawal symptoms, medication adherence, side effects, and adverse events using the Insight™ platform developed by the Stephenson Cancer Center (SCC) mHealth Shared Resource. This pilot study will provide information regarding the feasibility, acceptability, and preliminary efficacy of combination varenicline and oral NRT for smoking cessation, which will support an NIH fundin
Interventions
- DRUG Varenicline
- DRUG Oral Nicotine Replacement Therapy (NRT)
- BEHAVIORAL Medication Reminders
- BEHAVIORAL Tobacco Cessation Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2020-01-07 |
| Est. Completion | 2022-02-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03722966
The ClinicalTrials.gov registry entry for NCT03722966 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 34 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 4 interventions - of which Varenicline is the first listed.
NCT03722966 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03722966 about?
NCT03722966 is a clinical study titled "Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)". Varenicline is considered to be a first-line tobacco cessation treatment. Previous studies have evaluated the impact of the combination of varenicline and nicotine patches (versus varenicline alone) on smoking cessation, though findings have been equivocal. No studies to date have evaluated the comb...
What is the current status of trial NCT03722966?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2020-01-07. Estimated completion is 2022-02-07.
What interventions are being tested in trial NCT03722966?
The interventions under investigation include: Varenicline (DRUG), Oral Nicotine Replacement Therapy (NRT) (DRUG), Medication Reminders (BEHAVIORAL), Tobacco Cessation Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT03722966?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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