Assessing a new treatment for quitting smoking

Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy

This study is testing a new nicotine-free treatment to see if it can help people quit smoking by reducing their cravings.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 318 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: NFL Biosciences SAS (Industry-sponsored)
• Locations: 9 sites (Clermont-Ferrand and 8 other locations)
• Trial ID: NCT04571216 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of NFL-101, a nicotine-free extract of tobacco proteins, as a therapy for smoking cessation. It involves 318 participants in a multicentric, randomized, double-blind, placebo-controlled Phase II design. The study aims to identify the most effective dose of NFL-101 and assess its long-term effects on reducing cigarette cravings and aiding in quitting smoking. Participants will receive either one of two doses of NFL-101 or a placebo, with the goal of determining the best approach for tobacco cessation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who smoke at least 11 cigarettes per day and are motivated to quit.

Not a fit: Patients with uncontrolled medical conditions or severe psychiatric histories may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve smoking cessation rates and reduce nicotine dependence among smokers.

How similar studies have performed: Previous studies have shown promise with similar approaches, but this specific treatment is novel.

Eligibility criteria

Inclusion Criteria:

* Male or female subject ≥ 18 and ≤ 70-year-old;
* With ECOG/WHO performance status 0-1 (Appendix 1);
* Subject currently smoking at least 11 cigarettes per day and with a dependency level ≥ 3 according to Fagerström Test for Nicotine Dependence scoring (see Appendix 2) \[1\];
* Subject willing to quit smoking;
* Good general health (i.e. no uncontrolled medical condition, or no medical condition that could interfere with the conduct and the outcomes of the study, according to the investigator);
* Good mental health (i.e. no alcohol or drug abuse in the past year, no psychiatric history- adequately treated depression is accepted);
* 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, vasectomised partner or sexual abstinence for the duration of the trial; (Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea 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;
* Normal ECG recording on a 12-lead ECG at the screening visit:

  * 120 \< PR \< 210 ms,
  * QRS \< 120 ms,
  * QTcf ≤ 430 ms for male and \< 450 ms for female,
  * No sign of any trouble of sinusal automatism,
  * Or considered NCs by investigators;
* Negative prick test at screening visit for the whole study product (extract of Tobacco leaf and NaCL), and positive for histamine;
* French speaking subject;
* 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.

Exclusion Criteria:

* Pregnancy and breastfeeding;
* Concomitant participation to another clinical trial;
* Concomitant active infectious diseases;
* Concomitant use of treatment known to interfere with immune response (not including desensitization therapies);
* Uncontrolled diabetes;
* Prior exposure to a nicotine vaccine or to any other vaccine within 30 days before study product administration;
* Concomitant use (and within previous 60 days) of any smoking cessation therapy (including electronic cigarettes and alternative methods such as hypnosis or acupuncture);
* Legal incapacity or physical, psychological or mental status interfering with the subject's ability to sign the informed consent or to terminate the study.
* 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 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

Where this trial is running

Clermont-Ferrand and 8 other locations

• Centre d'Investigation Clinique de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
• CHU de Dijon — Dijon, France (Recruiting)
• Eurofins Optimed — Gières, France (Recruiting)
• Groupe Hospitalier Bretagne Sud — Lorient, France (Not_yet_recruiting)
• Centre d'Investigation Clinique de Marseille Nord — Marseille, France (Recruiting)
• Centre d'Investigation Clinique de Montpellier — Montpellier, France (Recruiting)
• Centre d'Investigation Clinique de Bordeaux — Pessac, France (Recruiting)
• Centre d'Investigation Clinique de Poitiers (CIC 1402) — Poitiers, France (Recruiting)
• Centre d'Investigation Clinique de Rennes — Rennes, France (Recruiting)

Study contacts

• Principal investigator: Yves Donazzolo, MD — Optimed Eurofins
• Study coordinator: Bruno Lafont, MS

Conditions Smoking Cessation; Nicotine Dependence