Efficacy and Safety of BP1.4979 in Smoking Cessation

Tobacco Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785147
• Other study ID #: P12-01 / BP1.4979
• Secondary ID: 2012-002731-28
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2013
• Last updated: January 20, 2015
• Start date: February 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Addiction

Intervention

Drug:
• BP1.4979
BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
• Placebo

Locations

Country	Name	City	State
France	Hôpital Paul Brousse	Villejuif	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Number of adverse events	Assessment of safety thanks to the number and clinical evaluation of the adverse events.	26 weeks	Yes
Secondary	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	Yes