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NCT03262662 · ClinicalTrials.gov registry record · Phase 3
EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
A Phase 3 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 3
- Development phase
- 320
- Enrollment target
NCT03262662 is a Phase 3 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 320 participants.
The verdict
NCT03262662, a Phase 3 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 320 participants
- Enrollment target
Study Summary
Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on promising preliminary clinical data, the study tests these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: The project aims to make best available treatment for smok
Interventions
- DRUG Varenicline
- BEHAVIORAL Brief smoking cessation counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2021-07-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03262662
The ClinicalTrials.gov registry entry for NCT03262662 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Varenicline is the first listed.
NCT03262662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03262662 about?
NCT03262662 is a clinical study titled "EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking". Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-wee...
What is the current status of trial NCT03262662?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2017-10-01. Estimated completion is 2021-07-08.
What interventions are being tested in trial NCT03262662?
The interventions under investigation include: Varenicline (DRUG), Brief smoking cessation counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT03262662?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
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