Use of Varenicline for 4-weeks Prior to Quitting
Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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London, United Kingdom, E1 2JH
- Tobacco Dependence Research and Treatment Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Varenicline pre-treatmemt
Participants will use varenicline (1mg BD) 4-weeks prior to quitting
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Varenicline 1mg twice daily
Other Names:
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PLACEBO_COMPARATOR: Placebo
Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
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Varenicline 1mg twice daily
Other Names:
Placebo 1mg BD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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24 hours and 7 days after quit date (week 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Pre-quit End-expired Carbon Monoxide Reading (CO)
Time Frame: Baseline - week 8
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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
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Change in Pre-quit Cotinine Levels
Time Frame: Weeks 1-4 (the first 4-weeks after first medication dose)
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Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.
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Weeks 1-4 (the first 4-weeks after first medication dose)
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Change in Pre-quit Ratings of Cigarette Satisfaction
Time Frame: Baseline - week 4
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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
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Baseline - week 4
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Change in Pre-quit Cigarette Consumption
Time Frame: Baseline - week 4
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Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.
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Baseline - week 4
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Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence
Time Frame: Week 4 - 8
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Al-Rehan A A Dhanji, MB BS BSc MRCP, Queen Mary University of London
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- qmul120508
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