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Efficacy and Safety of BP1.4979 in Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785147
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bioprojet

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).

Condition or disease Intervention/treatment Phase
Tobacco Addiction Drug: BP1.4979 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation
Study Start Date : February 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 4-week prolonged abstinence from smoking cigarettes [ Time Frame: 4 weeks ]

    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 :
  1. 7-day tobacco Point Prevalence Abstinence (PPA) [ Time Frame: 7 days ]
    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

  2. Number of adverse events [ Time Frame: 26 weeks ]
    Assessment of safety thanks to the number and clinical evaluation of the adverse events.

  3. Vital signs measures [ Time Frame: 26 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785147


Locations
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France
Hôpital Paul Brousse
Villejuif, Ile de France, France, 94800
Sponsors and Collaborators
Bioprojet
Investigators
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Principal Investigator: Henri-Jean AUBIN, MD, Ph.D Hôpital Paul Brousse

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Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01785147    
Other Study ID Numbers: P12-01 / BP1.4979
2012-002731-28 ( EudraCT Number )
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Bioprojet:
Tobacco addition
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior