Efficacy and Safety of BP1.4979 in Smoking Cessation

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

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).

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.

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.