Skip to main content
OpenTrials
Completed

NCT Number: NCT00789074

Use of Varenicline for 4-weeks Prior to Quitting

Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping.

The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as indicated by standard prescribing practice), followed by a 12-week open label treatment period where all participants will receive varenicline.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tobacco Dependence Research and Treatment Unit

London, E1 2JH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Smokers seeking treatment
  • Aged 18 and over
  • Consenting to take part in the trial

Exclusion criteria

  • Pregnant or breastfeeding
  • End-stage renal disease
  • Used varenicline in the past 6 months
  • Unable to fill in questionnaires in English
  • Current psychiatric illness
  • Current serious illness including uncontrolled hypertension and recent cardiac event
  • Sensitivity to varenicline currently enrolled in other research projects.

Treatment and study plan

Varenicline

Drug

Varenicline 1mg twice daily

Other names: Champix

Placebo

Drug

Placebo 1mg BD

Primary outcomes

  1. Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale

    Time frame: 24 hours and 7 days after quit date (week 4)

    The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.

Secondary outcomes

  1. Change in Pre-quit End-expired Carbon Monoxide Reading (CO)

    Time frame: Baseline - week 8

    Carbon monoxide concentration is measured in particles per million. It indicates smoke intake.

    CO was measured at each contact to monitor changes in smoke intake and differences between the study arms.

  2. Change in Pre-quit Cotinine Levels

    Time frame: Weeks 1-4 (the first 4-weeks after first medication dose)

    Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.

  3. Change in Pre-quit Ratings of Cigarette Satisfaction

    Time frame: Baseline - week 4

    Satisfaction measured on a scale of 1-5; "Have you found your cigarettes more or less enjoyable than usual in the last week?" 1= much more and 5 = much less

  4. Change in Pre-quit Cigarette Consumption

    Time frame: Baseline - week 4

    Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.

  5. Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence

    Time frame: Week 4 - 8

    Change in the Mood and Physical Symptoms Scale (MPSS)*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8).

    • The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual).

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Nov 11, 2008
Registry last updated
Dec 12, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.