Plain-English translation of NCT05257629 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether combining varenicline (a prescription medication that reduces cravings) with nicotine e-cigarettes works better than varenicline alone for helping people with heart disease quit smoking. About 798 people will participate across multiple hospitals. The study will follow participants for a full year to see how many stay smoke-free.
People who have had a heart attack or heart-related event and continue smoking have a much higher risk of having another heart attack or dying. Even when given varenicline, more than half of motivated patients return to smoking within 6 months. This trial is testing a more aggressive approach combining two nicotine treatments to help more people quit and stay quit.
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If you join this trial, you will be randomly assigned to receive either varenicline plus counseling, or varenicline plus nicotine e-cigarettes plus counseling. You will start the medication while still in the hospital and receive the e-cigarettes (if assigned) when you go home. You will have clinic visits at weeks 4 and 12, and phone follow-ups throughout the year, bringing your e-cigarette supplies and receipts to clinic visits so researchers can track your use and make sure the treatment is working safely.
AI-generated summary from trial data · Jul 4, 2026 · Not medical advice
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