Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
219 participants
INTERVENTIONAL
2013-02-28
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking
NCT00371813
Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
NCT01756053
Assessment of V0018 1.5 mg Effect on Craving
NCT02359201
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
NCT00139750
Test of Novel Drug for Smoking Cessation
NCT02217527
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BP1.4979 3mg
BP1.4979 3mg during 3 months
BP1.4979
BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
BP1.4979 10mg
BP1.4979 10mg during 3 months
BP1.4979
BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
BP1.4979 15mg
BP1.4979 15mg during 3 months
BP1.4979
BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
Placebo
Placebo during 3 months
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BP1.4979
BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bioprojet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henri-Jean AUBIN, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hôpital Paul Brousse
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Paul Brousse
Villejuif, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-002731-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P12-01 / BP1.4979
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.