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Varenicline

Clinical trials investigating Varenicline are studying its role in smoking cessation. This article looks at a Phase 3 trial in adult smokers and examines what the study aimed to measure, including quit rates and comparison with other approaches. The trial also includes a placebo group and evaluates people who smoke at least 10 cigarettes a day.

Table of contents

Trial overview

The provided clinical trial data include one interventional study of Varenicline for smoking cessation.[1] The study title was “Use of electronic cigarettes for smoking cessation,” and its brief summary says it aimed to assess electronic cigarettes containing nicotine compared with electronic cigarettes without nicotine and a licensed smoking cessation medicine, Varenicline.[1]

Who was studied

The study focused on smokers who had smoked at least 10 cigarettes per day in the past year.[1] This means the trial was aimed at people with regular smoking habits, not occasional smokers.[1]

What was compared in the trial

The trial compared three approaches: electronic cigarettes containing nicotine, electronic cigarettes without nicotine, and Varenicline.[1] It also included a placebo version of Varenicline, which is a look-alike treatment used for comparison when researchers want to measure the effect of the active study treatment more clearly.[1]

Trial phase and status

This was a Phase 3 trial, which is a later-stage study designed to test how well an intervention works in a larger group of people.[1] The study status was Suspended, meaning it was stopped for now and was not actively continuing in the data provided.[1] The trial planned to enroll 650 participants.[1]

Main endpoint

The primary outcome was the continuous smoking abstinence rate during the last 4 weeks of a 3-month treatment period.[1] In simple terms, the study wanted to see how many people stayed smoke-free without interruption near the end of treatment.[1]

What this means for patients

For patients, this trial is important because it looks at real smoking-cessation results, not just whether people start treatment.[1] The main question was whether Varenicline could help people remain smoke-free, and how it compared with two types of electronic cigarettes and placebo.[1]

Trial ID Phase Condition studied Status Enrollment
NCT03630614 Phase 3 Smokers smoking at least 10 cigarettes/day in the past year Suspended 650

FAQ

  • What is being studied in the Varenicline trial? The trial is studying smoking cessation, which means helping people stop smoking. It compares Varenicline with electronic cigarettes that contain nicotine, electronic cigarettes without nicotine, and placebo.
  • Who can take part in this study? The study includes smokers who have smoked at least 10 cigarettes a day in the past year. It is focused on adult smokers who want help with quitting.
  • What phase is the Varenicline trial? This study is a Phase 3 trial. Phase 3 studies usually test how well a treatment works in a larger group of people.
  • What result is the trial measuring? The main result is the continuous smoking abstinence rate during the last 4 weeks of a 3-month treatment period. This means the study checks how many people stayed smoke-free without interruption.
  • What is the status of the trial? The trial status is suspended. This means the study was stopped for now and is not currently moving forward.

Igangværende kliniske forsøg for Varenicline

  • Sammenligning af e-cigaretter og vareniclin til rygestop hos personer der ryger mindst 10 cigaretter dagligt

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Ordliste

  • Smoking cessation: The process of stopping smoking.
  • Phase 3: A later stage of clinical research that tests how well a treatment works in a larger group of people.
  • Placebo: A treatment that looks like the study drug but does not contain the active medicine.
  • Interventional study: A study in which researchers give a treatment or compare treatments to see what happens.
  • Continuous smoking abstinence: Staying smoke-free without starting again during the study period being measured.
  • Primary outcome: The main result the study is designed to measure.
  • Enrollment: The number of people planned to join the study.
  • Suspended: The study has been stopped for now and is not actively continuing.
  • Electronic cigarette: A device used in the study as a comparison treatment, with or without nicotine.
  • Nicotine: A substance used in some electronic cigarettes in this study comparison.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/sammenligning-af-e-cigaretter-og-vareniclin-til-rygestop-hos-personer-der-ryger-mindst-10-cigaretter-dagligt/