Efficacy and Safety of BP1.4979 in Smoking Cessation

Bioprojet

Status and phase: Completed; Phase 2

Conditions: Tobacco Addiction

Treatments: Drug: Placebo; Drug: BP1.4979

Study type: Interventional

Funder types: Other

Identifiers

NCT01785147

2012-002731-28 (EudraCT Number)

P12-01 / BP1.4979

Details and patient eligibility

About

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).

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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219 participants in 4 patient groups, including a placebo group

BP1.4979 3mg

Experimental group

Description:

BP1.4979 3mg during 3 months

Treatment:

Drug: BP1.4979

BP1.4979 10mg

Experimental group

Description:

BP1.4979 10mg during 3 months

Treatment:

Drug: BP1.4979

BP1.4979 15mg

Experimental group

Description:

BP1.4979 15mg during 3 months

Treatment:

Drug: BP1.4979

Placebo

Placebo Comparator group

Description:

Placebo during 3 months

Treatment:

Drug: Placebo