Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO)

NCT06091826 | Completed Phase 2

• 1 other identifier: v1.2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

PRECESTO is a randomized, double-blind, cross-over trial on 34 smokers who do not want to stop smoking and get high satisfaction from smoking. The primary objective is to assess efficacy of NFL-101 in reducing the positive reinforcing properties of cigarettes compared to placebo measured by the modified Cigarette Evaluation Questionnaire (mCEQ) "Smoking Satisfaction" (items 1, 2, and 12) subscale.

Conditions

Smoking Cessation; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Change of smoking satisfaction

  Success in achieving a 1 point reduction in the mCEQ "Smoking Satisfaction" subscale

  at Day 4

Secondary Outcomes (5)

• Change of smoking satisfaction

  at Day 7, at Day 14, at Day 21 and at Day 28

• Change in psychological reward, aversion, enjoyment of respiratory tract sensation and craving

  at Day 4, at Day 7, at Day 14, at Day 21 and at Day 28

• "Have you found your urges to smoke stronger or weaker than usual in the last 24 hours?"

  at Day 4, at Day 7, at Day 14, at Day 21 and at Day 28

• "Have you found cigarettes more or less enjoyable than usual in the last 24 hours?"

  at Day 4, at Day 7, at Day 14, at Day 21 and at Day 28

• Preference question : "Is there one of the two administrations that made you want to quit smoking or reduce your cigarette consumption more than the other?"

  at EOS visit

Study Arms (2)

NFL-101

EXPERIMENTAL

100 μg per subcutaneous injection (in each arm), two injections at day 1

Drug: NFL-101

Placebo

PLACEBO COMPARATOR

Water for Injection (WFI), two injections at day 1

Drug: Placebo

Interventions

NFL-101 DRUG

Subcutaneous injections

Also known as: Tobacco leaf extract

NFL-101

Placebo DRUG

Subcutaneous injections

Also known as: Water for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Equipped with a web connection via a computer or tablet;
• 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.

You may not qualify if:

• Pregnancy and breastfeeding;
• Concomitant participation to another clinical trial;
• Concomitant active infectious diseases;
• Suicidal or depressive state
• Positive results of screening for drugs of abuse
• History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day);
• 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.

Sponsors & Collaborators

• NFL Biosciences SAS: lead

Study Sites (1)

Eurofins Optimed

Gières, Isère, 38610, France

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Tobacco Products; Water; Injections

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yves Donazzolo, MD

  Eurofins Optimed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Eurofins Optimed

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: October 19, 2023
• Study Start: February 21, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 30, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)