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Completed

NCT Number: NCT01244061

A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Australian Clinical Research Network, Maroubra, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Smokers aged 18 years or above and wanting to stop smoking
  • Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
  • Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
  • The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion criteria

  • Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
  • Individuals who have previously participated in clinical trials of varenicline
  • Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days

Treatment and study plan

Varenicline

Drug

Varenicline 1mg twice daily

Placebo

Drug

Matched placebo twice daily

Primary outcomes

  1. Continuous Abstinence Rate (CAR) From Week 9 Through Week 12

    Time frame: Week 9 through Week 12

    The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.

Secondary outcomes

  1. CAR From Week 9 Through Week 52

    Time frame: Week 9 through Week 52

    The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.

  2. CAR From Week 9 Through Week 24

    Time frame: Week 9 through Week 24

    The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.

  3. 7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52

    Time frame: Weeks 12, 24 and 52

    The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the "last 7 days" questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2010
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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