Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)

Study Overview
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Brief Summary
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Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.

Official Title
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Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke

Conditions
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Tobacco Dependence, Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine Patch
* Drug: Placebo
* Drug: Varenicline


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 Unable to fill in questionnaires in English Previous allergy to Varenicline Previous allergy to Nicotine Patches Previous allergy to varenicline

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 + Active Patch<br>Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch | Drug: Nicotine Patch<br>* Varenicline + nicotine patch<br>* Other names: Chantix;Drug: Varenicline<br>* All participants will receive a standard dose of varenicline (12 weeks).<br>* Other names: Chantix;|
| Placebo Comparator: Varenicline + Placebo Patch<br>Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch | Drug: Placebo<br>* Varenicline + placebo patch<br>* Other names: Chantix;Drug: Varenicline<br>* All participants will receive a standard dose of varenicline (12 weeks).<br>* Other names: Chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale | Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated abstinence rates over weeks 1-12 post target quit date |  | 12 weeks post target quit date | 
| Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale |  | 4-weeks post quitting | 
| Profile of all adverse effects reported up to 12-weeks post quitting |  | Up to 12-weeks post quitting | 
| Ratings of urges to smoke 24 hours after the target quit date | Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Tobacco dependence, Varenicline, Nicotine Replacement Therapy, Combination therapy