Efficacy and Safety of BP1.4979 in Smoking Cessation

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioprojet

Criteria

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.