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Efficacy and Safety of BP1.4979 in Smoking Cessation

Primary Purpose

Tobacco Addiction

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
BP1.4979
Placebo
Sponsored by
Bioprojet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Addiction focused on measuring Tobacco addition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Paul Brousse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BP1.4979 3mg

BP1.4979 10mg

BP1.4979 15mg

Placebo

Arm Description

BP1.4979 3mg during 3 months

BP1.4979 10mg during 3 months

BP1.4979 15mg during 3 months

Placebo during 3 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Number of adverse events
Assessment of safety thanks to the number and clinical evaluation of the adverse events.
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.

Full Information

First Posted
February 5, 2013
Last Updated
January 20, 2015
Sponsor
Bioprojet
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1. Study Identification

Unique Protocol Identification Number
NCT01785147
Brief Title
Efficacy and Safety of BP1.4979 in Smoking Cessation
Official Title
Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioprojet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Addiction
Keywords
Tobacco addition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BP1.4979 3mg
Arm Type
Experimental
Arm Description
BP1.4979 3mg during 3 months
Arm Title
BP1.4979 10mg
Arm Type
Experimental
Arm Description
BP1.4979 10mg during 3 months
Arm Title
BP1.4979 15mg
Arm Type
Experimental
Arm Description
BP1.4979 15mg during 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo during 3 months
Intervention Type
Drug
Intervention Name(s)
BP1.4979
Intervention Description
BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
4-week prolonged abstinence from smoking cigarettes
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
7-day tobacco Point Prevalence Abstinence (PPA)
Description
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
Time Frame
7 days
Title
Number of adverse events
Description
Assessment of safety thanks to the number and clinical evaluation of the adverse events.
Time Frame
26 weeks
Title
Vital signs measures
Description
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.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri-Jean AUBIN, MD, Ph.D
Organizational Affiliation
Hôpital Paul Brousse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Paul Brousse
City
Villejuif
State/Province
Ile de France
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

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Efficacy and Safety of BP1.4979 in Smoking Cessation

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