Tailoring Varenicline to Individual Needs (TVIN Study)

Study Overview
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Brief Summary
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Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions (primarily nausea) in sensitive clients. The downside of this cautious approach is that a substantial proportion of clients may be under-dosed. A blanket dose increase would inevitably increase the incidence of side effects, but it is likely that tailoring varenicline dosing to clients' needs would be safe and may further increase varenicline's efficacy. This study will recruit 200 smokers who report little change to their enjoyment of cigarettes and no nausea, during the first week of varenicline use. These smokers will be randomised to receive the standard dose plus placebo or plus individualised varenicline dose up to 5mg, titrated over the next week prior to their target quit day. Urges to smoke, and other withdrawal symptoms, experienced during the study period will be compared between groups to see if the tailored therapy may be useful.

Official Title
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Effects of a Tailored Dose of Varenicline 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
* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoker seeking treatment Aged 18 and over Consenting to take part Report little or no change in enjoyment of cigarettes and/or nausea Exclusion Criteria: Pregnant or breastfeeding Have severe kidney disease Have severe heart problems Have a current psychiatric illness Are unable to fill in questionnaires in English Have an allergy to varenicline Are currently involved in another clinical trial

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 Tailored Dose<br> | Drug: Varenicline<br>* Participants will increase varenicline dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard dose of 1.0 mg twice daily.<br>* Other names: Chantix;Drug: Varenicline<br>* All participants will receive the standard dose of Varenicline (14 weeks): 0.5 mg once daily for days 1-3, 0.5 mg twice daily for days 4-7, and then a continuation dose of 1.0 mg twice daily. In addition to this participants will use an tailored varenicline/placebo dose up to maximum of 2.5 mg twice daily for 3 weeks.<br>* Other names: Chantix;|
| Placebo Comparator: Varenicline + Placebo Tailored Dose<br> | Drug: Placebo<br>* Participants will increase placebo dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard varenicline dose of 1.0 mg twice daily.<br>* Other names: Chantix;Drug: Varenicline<br>* All participants will receive the standard dose of Varenicline (14 weeks): 0.5 mg once daily for days 1-3, 0.5 mg twice daily for days 4-7, and then a continuation dose of 1.0 mg twice daily. In addition to this participants will use an tailored varenicline/placebo dose up to maximum of 2.5 mg twice daily for 3 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 1-week after the target quit | Rating of urges to smoke will be assessed using the Mood & Physical Symptoms Scale | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the number of people with no effect of varenicline (as measured on a self reported questionnaire) prior to the target quit date |  | 2 weeks pre quitting | 
| The change of withdrawal symptoms from target quit day over the first 4-weeks of abstinence assessed by the Mood and Physical Symptoms Scale |  | 4 weeks post quitting | 
| Validated abstinence rates at 1-12 weeks post target quit date |  | 1-12 weeks post target quit date | 
| Profile of all adverse effects (as measured by a self reported questionnaire) reported up to 12-weeks post quitting |  | Up to 12 weeks post quitting | 
| Client ratings (measured using a self-reporting questionnaire) of tailored treatment regimen |  | Up to 12 weeks post quit | 
| Rating of urges to smoke 24 hours post target quit date |  | 24 hours post target quit date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco Dependence, Smoking cessation, Varenicline, Tailored dosing