Use of Varenicline for 4-weeks Prior to Quitting

Study Overview
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Brief Summary
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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.

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

Conditions
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Tobacco Dependence, Smoking Cessation

Intervention / Treatment
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* Drug: Varenicline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline pre-treatmemt<br>Participants will use varenicline (1mg BD) 4-weeks prior to quitting | Drug: Varenicline<br>* Varenicline 1mg twice daily<br>* Other names: Champix;|
| Placebo Comparator: Placebo<br>Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting | Drug: Varenicline<br>* Varenicline 1mg twice daily<br>* Other names: Champix;Drug: Placebo<br>* Placebo 1mg BD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale | 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. | 24 hours and 7 days after quit date (week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pre-quit End-expired Carbon Monoxide Reading (CO) | 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. | Baseline - week 8 | 
| Change in Pre-quit Cotinine Levels | Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose. | Weeks 1-4 (the first 4-weeks after first medication dose) | 
| Change in Pre-quit Ratings of Cigarette Satisfaction | 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 | Baseline - week 4 | 
| Change in Pre-quit Cigarette Consumption | Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period. | Baseline - week 4 | 
| Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence | 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). | Week 4 - 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco dependence, Smoking cessation, Varenicline, Preloading