A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

Study Overview
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Brief Summary
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This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.

Official Title
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A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Varenicline Tartrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months. Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) >10 ppm at screening. Subjects with mild to moderate depression or anxiety may be included if their condition is stable. Exclusion Criteria: Subjects with a history of a suicide attempt or any suicidal behavior in the past two years. Subjects with severe depression or anxiety. Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia. Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Varenicline Tartrate<br> | Drug: Varenicline Tartrate<br>* Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking | Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). | Week 15 - 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With CO Confirmed 4-Week CA From Smoking | Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). | Week 21 - 24 | 
| Percentage of Participants With CO Confirmed Long Term CA From Smoking | Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). | Weeks 21 - 52 | 
| Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation | The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant's smoking status and other nicotine use was evaluated based on the last 7 days questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 7 days?; and Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm). | Week 12, 24, and 52 | 
| Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation | The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant's smoking status and other nicotine use was evaluated based on the last 4 weeks questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?; and Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm). | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking reduction, smoking cessation