- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06091826
Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO) (PRECESTO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Isère
-
Gières, Isère, France, 38610
- Eurofins Optimed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NFL-101
100 μg per subcutaneous injection (in each arm), two injections at day 1
|
Subcutaneous injections
Other Names:
|
Placebo Comparator: Placebo
Water for Injection (WFI), two injections at day 1
|
Subcutaneous injections
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of smoking satisfaction
Time Frame: at Day 4
|
Success in achieving a 1 point reduction in the mCEQ "Smoking Satisfaction" subscale
|
at Day 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of smoking satisfaction
Time Frame: at Day 7, at Day 14, at Day 21 and at Day 28
|
Success in achieving a 1 point reduction in mCEQ "Smoking Satisfaction" subscale
|
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
|
Success in achieving a 1 point reduction in mCEQ "Psychological Reward"; "Aversion"; "Enjoyment of Respiratory Tract Sensations"; and "Craving Reduction" subcales
|
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
|
With response options of "much stronger," "slightly stronger," "same as before," "slightly weaker," and "much weaker"
|
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
|
With response options of "much more enjoyable," "slightly more enjoyable," "same as before," "slightly less enjoyable," and "much less enjoyable"
|
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
|
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
|
at EOS visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yves Donazzolo, MD, Eurofins Optimed
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- v1.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
The University of Hong KongNot yet recruitingSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States