Randomized placebo controlled trial assessing the efficacy and safety of BP1.4979 in smoking cessation

Bioprojet0 sites250 target enrollmentOctober 31, 2012

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. males or females, aged 18 to 65 years old
•2\. 18 kg/m2 \= BMI \= 35 kg/m2
•3\. a smoking history of at least 10 years
•4\. subject smoking at least 15 cigarettes per day at the time being and for at least 30 days before selection.
•5\. motivated to quit smoking with a motivation test score \> 12 on the Legeron and Lagrue Questionnaire of Motivation (Q\-MAT) at the selection and at the inclusion
•6\. having already made at least 2 attempts to stop (each of at least 7 days), including at least one attempt with medical and pharmacological
•treatment, at least 30 days before the selection
•7\. with no period of abstinence \> 3 months in the previous year
•8\. Fagerström Test of Nicotine Dependence (FTND) ? 7 at V0 (screening) and/or at V1 (randomization)
•9\. not taking anti\-smoking medication

•1\. any significant psychiatric illness (schizophrenia, bipolar disorder, severe depression, dementia...) or mood disorder, assessed by the Beck
•Depression Inventory (BDI) (exclusion if ? 8 and/ or item G ? 0\).
•2\. Hospital Anxiety and Depression (HAD) scale (A \+ D \= 19, the day of the selection and inclusion).
•3\. substance use disorder (except nicotine).
•4\. Alcohol Use Disorders Identification Test (AUDIT) ? 8\.
•5\. any use of non prescription opiates / stimulants (amphetamines),
•cocaine or cannabis in the 3 previous months.
•6\. positive urinary test on opiates, amphetamine, cannabis or cocaine.
•7\. other active clinically significant illness, including unstable
•cardiovascular, or neoplasic pathology which could interfere with the study conduct or counter\-indicate the study treatments or place the