Use of Varenicline for 4-weeks Prior to Quitting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Peter Hajek, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT00789074
First received: November 7, 2008
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Tobacco Dependence
Smoking Cessation
Drug: Varenicline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Change in Pre-quit End-expired Carbon Monoxide Reading (CO) [ Time Frame: Baseline - week 8 ] [ Designated as safety issue: No ]

    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.


  • Change in Pre-quit Cotinine Levels [ Time Frame: Weeks 1-4 (the first 4-weeks after first medication dose) ] [ Designated as safety issue: No ]
    Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.

  • Change in Pre-quit Ratings of Cigarette Satisfaction [ Time Frame: Baseline - week 4 ] [ Designated as safety issue: No ]
    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

  • Change in Pre-quit Cigarette Consumption [ Time Frame: Baseline - week 4 ] [ Designated as safety issue: No ]
    Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.

  • Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence [ Time Frame: Week 4 - 8 ] [ Designated as safety issue: No ]

    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).



Enrollment: 101
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789074

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

No publications provided by Queen Mary University of London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Peter Hajek, Professor of Clinical Psychology, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT00789074     History of Changes
Other Study ID Numbers: qmul120508
Study First Received: November 7, 2008
Results First Received: August 4, 2011
Last Updated: November 18, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Queen Mary University of London:
Smoking cessation
Tobacco dependence
Varenicline
Preloading

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014