Smoking CessationPhase 2PRECESTONCT06091826
Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO)
A Phase 2 study testing NFL-101 in people with Smoking Cessation and Nicotine Dependence, run by NFL Biosciences SAS at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Nicotine Dependence
- What is being tested?
- NFL-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2023to 30 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO Trial)
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.
Read the 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.
- Conditions
- Smoking Cessation, Nicotine Dependence
- Being tested
- NFL-101, Placebo
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NFL-101Drug
Also called Tobacco leaf extract
Subcutaneous injections
PlaceboDrug
Also called Water for injection
Subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| NFL-101 | Experimental | 100 μg per subcutaneous injection (in each arm), two injections at day 1 Receives: Drug: NFL-101 |
| Placebo | Placebo comparator | Water for Injection (WFI), two injections at day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of smoking satisfaction
Success in achieving a 1 point reduction in the mCEQ "Smoking Satisfaction" subscale
Measured: at Day 4
Secondary outcomes (5)
Change of smoking satisfaction
Success in achieving a 1 point reduction in mCEQ "Smoking Satisfaction" subscale
Measured: 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
Success in achieving a 1 point reduction in mCEQ "Psychological Reward"; "Aversion"; "Enjoyment of Respiratory Tract Sensations"; and "Craving Reduction" subcales
Measured: 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?"
With response options of "much stronger," "slightly stronger," "same as before," "slightly weaker," and "much weaker"
Measured: 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?"
With response options of "much more enjoyable," "slightly more enjoyable," "same as before," "slightly less enjoyable," and "much less enjoyable"
Measured: 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?"
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
Measured: at EOS visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start21 Feb 2023
- Primary completion15 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- NFL Biosciences SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Yves Donazzolo, NFL Biosciences SAS
- Investigators
- Yves Donazzolo, MD, Principal investigator, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091826
- Sponsor's protocol ID
- v1.2
- Acronym
- PRECESTO
- Status last verified
- Oct 2023
- First submitted
- 21 Feb 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO Trial)
- ClinicalTrials.gov ID
- NCT06091826
- Acronym / sponsor ID
- PRECESTO / v1.2
- Conditions
- Smoking Cessation, Nicotine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- NFL Biosciences SASIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NFL-101 | Experimental | Drug: NFL-101100 μg per subcutaneous injection (in each arm), two injections at day 1 |
| Placebo | Placebo comparator | Drug: PlaceboWater for Injection (WFI), two injections at day 1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NFL-101Also: Tobacco leaf extractSubcutaneous injections | Drug | NFL-101 |
| PlaceboAlso: Water for injectionSubcutaneous injections | Drug | Placebo |
Primary outcome
Change of smoking satisfaction
Time frame: at Day 4
Success in achieving a 1 point reduction in the mCEQ "Smoking Satisfaction" subscale
5 secondary outcomes
Change of smoking satisfaction
Time frame: 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
Time frame: 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?"
Time frame: 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?"
Time frame: 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?"
Time frame: at EOS visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Donazzolo, MD principal investigator
Eurofins Optimed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NFL-101 in people with Smoking Cessation and Nicotine Dependence, run by NFL Biosciences SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of smoking satisfaction (time frame: at Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.