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Use of Varenicline for 4-weeks Prior to Quitting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00789074
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : June 25, 2012
Last Update Posted : December 12, 2013
Information provided by (Responsible Party):
Professor Peter Hajek, Queen Mary University of London

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Smoking Cessation Drug: Varenicline Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke
Study Start Date : July 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Varenicline pre-treatmemt
Participants will use varenicline (1mg BD) 4-weeks prior to quitting
Drug: Varenicline
Varenicline 1mg twice daily
Other Name: Champix

Placebo Comparator: Placebo
Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
Drug: Varenicline
Varenicline 1mg twice daily
Other Name: Champix

Drug: Placebo
Placebo 1mg BD

Primary Outcome Measures :
  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 Outcome Measures :
  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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00789074

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United Kingdom
Tobacco Dependence Research and Treatment Unit
London, United Kingdom, E1 2JH
Sponsors and Collaborators
Queen Mary University of London
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Principal Investigator: Al-Rehan A A Dhanji, MB BS BSc MRCP Queen Mary University of London

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Peter Hajek, Professor of Clinical Psychology, Queen Mary University of London Identifier: NCT00789074     History of Changes
Other Study ID Numbers: qmul120508
First Posted: November 11, 2008    Key Record Dates
Results First Posted: June 25, 2012
Last Update Posted: December 12, 2013
Last Verified: November 2013
Keywords provided by Professor Peter Hajek, Queen Mary University of London:
Smoking cessation
Tobacco dependence
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs