Efficacy and Safety of BP1.4979 in Smoking Cessation

Study Overview
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Brief Summary
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Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent < 10 ppm).

Detailed Description
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BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase I studies. This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with parallel group to assess safety and efficacy of BP1.4979 in smoker.

Official Title
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Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation

Conditions
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Tobacco Addiction

Intervention / Treatment
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* Drug: BP1.4979
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main inclusion Criteria: a smoking history of at least 10 years subject smoking at least 15 cigarettes per day at the time being and for at least 30 days before selection. having already made at least 2 attempts to stop with no period of abstinence > 3 months in the previous year FTND ≥ 7 Main exclusion Criteria: any significant psychiatric illness or mood disorder, assessed by the BDI HAD scale (A + D ≥ 19, the day of the selection and inclusion) AUDIT ≥ 8 subject smoking cigars or pipes exclusively subject taking any antismoking medication and/ or Nicotine Replacement Therapy (NRT) in the previous month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BP1.4979 3mg<br>BP1.4979 3mg during 3 months | Drug: BP1.4979<br>* BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.<br>|
| Experimental: BP1.4979 10mg<br>BP1.4979 10mg during 3 months | Drug: BP1.4979<br>* BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.<br>|
| Experimental: BP1.4979 15mg<br>BP1.4979 15mg during 3 months | Drug: BP1.4979<br>* BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.<br>|
| Placebo Comparator: Placebo<br>Placebo during 3 months | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-week prolonged abstinence from smoking cigarettes | The primary measure of efficacy will be 4-week prolonged abstinence from smoking cigarettes at the end of 12-week double-blind treatment phase (i.e. from V3 to V4). The continuous abstinence measured by subject diary and verified by exhaled CO (abstinent < 10 ppm) will define response to the treatment. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day tobacco Point Prevalence Abstinence (PPA) | 7-day tobacco Point Prevalence Abstinence (PPA) will be assessed at each visit by analysis of cigarettes consumption using self-report diaries and measurement of exhaled CO | 7 days | 
| Number of adverse events | Assessment of safety thanks to the number and clinical evaluation of the adverse events. | 26 weeks | 
| Vital signs measures | Vital signs (measurement of heart rate, blood pressure, and body weight) will be assessed at each study visit, thanks to physical examinations (V0 and V4), ECG and laboratory tests (blood chemistry, haematology, urinanalysis tests, prolactin dosage) at screening (V0), after 4-week treatment (V2) and at V4. | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco addition