Smoking cessatio

Conditions: Smoking cessation
MedDRA version: 16.1Level: LLTClassification code 10008374Term: Cessation of smokingSystem Organ Class: 100000004869
Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

Registration Number: EUCTR2012-002731-28-CZ

Lead Sponsor: Bioprojet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

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
10. not taking antipsychotic medication, antidepressant except Selective Serotonin Reuptake Inhibitors (SSRIs) prescribed for at least one month (e.g. fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram, venlafaxine, milnacipran, duloxetine) and/or any other psychotropic medication except benzodiazepine treatment stable for at least one month prior to inclusion in the study.
11. females of child-bearing potential must use a medically accepted
effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding subject.
12. in the opinion of the investigator, the subject must have adequate
support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, self rating scales,
drug compliance, scheduled visits, etc).
13. subject must have voluntarily expressed willingness to participate in
this study, understand protocol procedures and have signed and dated
an informed consent prior to beginning any protocol required
procedures.
14. attend usual smoking cessation counseling provided by investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 subject at risk during the trial or compromise the study participation.
8. subject with a known history of long QTc syndrome (e.g. syncope or
arrhythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTcB interval strictly higher than 450 ms for man and 460 ms for woman (electrocardiogram Bazett's corrected QT interval: QTc=QT/? [60/HR]).
9. subject with severe hepatic impairment or with severe renal
impairment, or with any other significant abnormality in the physical examination or clinical laboratory results (e.g positive laboratory test for Hepatitis B surface antigen (HBsAg), or anti-HIV 1/2 or anti- HCV antibodies).
10. known hypersensitivity to the tested treatment including active
substance and excipients.
11. subject smoking cigars or pipes in addition to cigarettes (patient
should have stopped cigars or pipes at least 30 days before V0)
12. subject taking any antismoking medication (e.g. bupropion,
varenicline, clonidine, cytisine..), and/ or Nicotine Replacement Therapy (NRT) in the previous month.
13. subject taking antipsychotic medication, or antidepressants other
than SSRIs (SSRIs taking for at least one month).
14. subject taking anxiolytics (except benzodiazepines at stable dose for
at least 1 month).
15. subject taking any prescription drug containing amphetamines.
16. subject on anti smoking targeted Cognitive Behavioral Therapy (CBT)
or any antismoking oriented psychotherapy or acupuncture or using an electronic cigarette.
17. subject participating in another study and the use of any investigational therapy within the 30 days prior to the entry in this study.
18. subject without any medical care insurance.
19. pregnant woman or a pregnancy detected with a positive serum
pregnancy test performed at the screening visit.
20. male subject who wants to conceive a child for the whole duration of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess in heavy smokers willing to quit smoking the efficacy and the<br>safety profile of BP1.4979 for smoking cessation on the total abstinence<br>measured by subject diary and confirmed by exhaled CO (abstinent = 10<br>ppm).;Secondary Objective: No secondary objectives were established;Primary end point(s): 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).<br>The continuous abstinence measured by subject diary and verified by exhaled CO (abstinent < 10 ppm) will define response to the treatment.<br><br>;Timepoint(s) of evaluation of this end point: During treatment phase and up to 3 months after treatment.

Secondary Outcome Measures