Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO) (PRECESTO)
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|ClinicalTrials.gov Identifier: NCT06091826|
Recruitment Status : Completed
First Posted : October 19, 2023
Last Update Posted : October 19, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Nicotine Dependence||Drug: NFL-101 Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO Trial)|
|Actual Study Start Date :||February 21, 2023|
|Actual Primary Completion Date :||September 15, 2023|
|Actual Study Completion Date :||September 30, 2023|
100 μg per subcutaneous injection (in each arm), two injections at day 1
Other Name: Tobacco leaf extract
Placebo Comparator: Placebo
Water for Injection (WFI), two injections at day 1
Other Name: Water for injection
- Change of smoking satisfaction [ Time Frame: at Day 4 ]Success in achieving a 1 point reduction in the mCEQ "Smoking Satisfaction" subscale
- 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
- 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
- "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"
- "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"
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06091826
|Gières, Isère, France, 38610|
|Principal Investigator:||Yves Donazzolo, MD||Eurofins Optimed|