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Completed

NCT Number: NCT01785147

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).

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Key information

Conditions

Tobacco Addiction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Paul Brousse

Villejuif, Île-de-France Region, 94800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BP1.4979

Drug

BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.

Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2013
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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