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).

Study Overview

• Status: Completed
• Conditions: Tobacco Addiction
• Intervention / Treatment: Drug: Placebo; Drug: BP1.4979

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Villejuif, Ile de France, France, 94800
      • Hopital Paul Brousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BP1.4979 3mg; BP1.4979 3mg during 3 months	Drug: BP1.4979; BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
Experimental: BP1.4979 10mg; BP1.4979 10mg during 3 months	Drug: BP1.4979; BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
Experimental: BP1.4979 15mg; BP1.4979 15mg during 3 months	Drug: BP1.4979; BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
Placebo Comparator: Placebo; Placebo during 3 months	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bioprojet
• Investigators: Principal Investigator: Henri-Jean AUBIN, MD, Ph.D, Hopital Paul Brousse

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Tobacco addition
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: P12-01 / BP1.4979; 2012-002731-28 (EudraCT Number)