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

Primary Purpose

Smoking Cessation, Nicotine Dependence

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
NFL-101
Placebo
Sponsored by
NFL Biosciences SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Eurofins Optimed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NFL-101

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of smoking satisfaction
Success in achieving a 1 point reduction in the mCEQ "Smoking Satisfaction" subscale

Secondary Outcome Measures

Change of smoking satisfaction
Success in achieving a 1 point reduction in mCEQ "Smoking Satisfaction" subscale
Change in psychological reward, aversion, enjoyment of respiratory tract sensation and craving
Success in achieving a 1 point reduction in mCEQ "Psychological Reward"; "Aversion"; "Enjoyment of Respiratory Tract Sensations"; and "Craving Reduction" subcales
"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"
"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"
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?"
With response options of administration 1, administration 2, I dont know, imponderable factors (for example covid, death of a relative, job loss, etc.) do not allow me to answer

Full Information

First Posted
February 21, 2023
Last Updated
October 18, 2023
Sponsor
NFL Biosciences SAS
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1. Study Identification

Unique Protocol Identification Number
NCT06091826
Brief Title
Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO)
Acronym
PRECESTO
Official Title
Phase II Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NFL Biosciences SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
PRECESTO is a monocentric, placebo-controlled, randomized and double-blind Phase 2a exploratory study, with a crossover covering two periods of 28 days each, including 34 smokers who do not want to quit and have high smoking satisfaction. Each participant is his or her own control and receives, on a random and alternating basis, either NFL-101 or the placebo at the start of each of the two periods. At the end of the study, all the participants received one dose of NFL-101 and one dose of the placebo. For each participant, the order in which NFL-101 and the placebo are administered is kept secret. For each period, the participants receive the treatments on day 1 (D1) then answer, with complete independence, the modified Cigarette Evaluation Questionnaire (mCEQ) on days 4 (D4), 7 (D7), 14 (D14), 21 (D21) and 28 (D28). The objective is to assess the safety and efficacy of NFL-101 as a pretreatment for smoking cessation, NFL-101 beeing administered a few days or weeks before a quit attempt while smokers are asked to smoke ad libitum (meaning to continue either to try to smoke the same amount or to smoke freely). It is indeed recognized that reducing satisfaction from smoking before a quit attempt begins to undermine the learned association between smoking and reward and thus promotes the success of these attempts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Nicotine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NFL-101
Arm Type
Experimental
Arm Description
100 μg per subcutaneous injection (in each arm), two injections at day 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Water for Injection (WFI), two injections at day 1
Intervention Type
Drug
Intervention Name(s)
NFL-101
Other Intervention Name(s)
Tobacco leaf extract
Intervention Description
Subcutaneous injections
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Water for injection
Intervention Description
Subcutaneous injections
Primary Outcome Measure Information:
Title
Change of smoking satisfaction
Description
Success in achieving a 1 point reduction in the mCEQ "Smoking Satisfaction" subscale
Time Frame
at Day 4
Secondary Outcome Measure Information:
Title
Change of smoking satisfaction
Description
Success in achieving a 1 point reduction in mCEQ "Smoking Satisfaction" subscale
Time Frame
at Day 7, at Day 14, at Day 21 and at Day 28
Title
Change in psychological reward, aversion, enjoyment of respiratory tract sensation and craving
Description
Success in achieving a 1 point reduction in mCEQ "Psychological Reward"; "Aversion"; "Enjoyment of Respiratory Tract Sensations"; and "Craving Reduction" subcales
Time Frame
at Day 4, at Day 7, at Day 14, at Day 21 and at Day 28
Title
"Have you found your urges to smoke stronger or weaker than usual in the last 24 hours?"
Description
With response options of "much stronger," "slightly stronger," "same as before," "slightly weaker," and "much weaker"
Time Frame
at Day 4, at Day 7, at Day 14, at Day 21 and at Day 28
Title
"Have you found cigarettes more or less enjoyable than usual in the last 24 hours?"
Description
With response options of "much more enjoyable," "slightly more enjoyable," "same as before," "slightly less enjoyable," and "much less enjoyable"
Time Frame
at Day 4, at Day 7, at Day 14, at Day 21 and at Day 28
Title
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?"
Description
With response options of administration 1, administration 2, I dont know, imponderable factors (for example covid, death of a relative, job loss, etc.) do not allow me to answer
Time Frame
at EOS visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Donazzolo, MD
Organizational Affiliation
Eurofins Optimed
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurofins Optimed
City
Gières
State/Province
Isère
ZIP/Postal Code
38610
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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