Tobacco addiction MedDRA version: 23.0 Level: HLT Classification code 10043905 Term: Tobacco use System Organ Class: 100000004869
Conditions
Interventions
Product Code: NFL-101
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Sponsors
NFL BIOSCIENCES SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • • Male or female subject = 18 and = 70-year-old at the time of consent; • Internet connection; • Subject currently smoking at least 10 cigarettes per day; • Exhaled CO = 9 ppm; • Subject with a mCEQ Satisfaction subscale score = 4 • Subject not wanting to stop smoking (MTSS score = 2) • Subject not under tobacco cessation therapy since at least 30 days; • Considered as healthy for the study after a comprehensive clinical assessment (detailed medical history and complete physical examination); • For women of childbearing potential: commitment to consistently and correctly use of a highly effective contraceptive measure: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence for the duration of the trial; • Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months); • Negative pregnancy test at screening visit; • Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests). Individual values out of the normal range can be accepted if judged clinically non relevant by the investigator; • Negative prick test at screening visit for the whole study product (extract of Tobacco leaf and NaCL), and positive for histamine; • Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research; • Subject having signed the informed consent agreement. 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 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: • Pregnancy and breastfeeding; • Concomitant participation to another clinical trial; • Concomitant active infectious diseases; • Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study (for subjects in France only); • Subject who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of NFL-101 in reducing the positive reinforcing properties of cigarettes compared to placebo measured by the mCEQ "Smoking Satisfaction" (items 1, 2, and 12) subscale.;Secondary Objective: To assess efficacy of NFL-101 in reducing the reinforcing properties of cigarettes compared to a placebo and safety after one administration of NFL-101. ;Primary end point(s): The primary endpoint is the mCEQ "Smoking Satisfaction" subscale measured at D4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • mCEQ "Smoking Satisfaction" (items 1, 2, and 12) subscale measured at D7, D14, D21 and D28 • mCEQ "Psychological Reward" (items 4 through 8); "Aversion" (items 9 and 10); "Enjoyment of Respiratory Tract Sensations" (item 3); and "Craving Reduction“ (item 11) subcales, measured at D4, D7, D14, D21 and D28 • Question “Have you found your urges to smoke stronger or weaker than usual in the last 24 hours?” (with response options of “much stronger,” “slightly stronger,” “same as before,” “slightly weaker,” and “much weaker”) at D4, D7, D14, D21 and D28 • Question “Have you found cigarettes more or less enjoyable than usual in the last 24 hours?” (with response options of “much more enjoyable,” “slightly more enjoyable,” “same as before,” “slightly less enjoyable,” and “much less enjoyable”) at D4, D7, D14, D21 and D28 • Change in MTSS from screening to D28 • Change in number of cigarettes smoked from screening to D28 • Preference question at EOS visit: “Is there one of the two administrations that made you want to quit smoking or reduce your cigarette consumption more than the other?” | — |
Countries
France
Contacts
Public ContactFélix Collet
EUROFINS OPTIMED
Outcome results
None listed