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.
|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|
- 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.
- 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).
|Study Start Date:||July 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Varenicline pre-treatmemt
Participants will use varenicline (1mg BD) 4-weeks prior to quitting
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
Varenicline 1mg twice daily
Other Name: ChampixDrug: Placebo
Placebo 1mg BD
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789074
|Tobacco Dependence Research and Treatment Unit|
|London, United Kingdom, E1 2JH|
|Principal Investigator:||Al-Rehan A A Dhanji, MB BS BSc MRCP||Queen Mary University of London|