A Phase 2 interventional study of NFL-101 and Placebo in Smoking Cessation and Nicotine Dependence, sponsored by NFL Biosciences SAS. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by NFL Biosciences SAS · Phase 2, Interventional, and Treatment
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.
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 34 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →NFL Biosciences SAS is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100 μg per subcutaneous injection (in each arm), two injections at day 1
Drug: NFL-101
Water for Injection (WFI), two injections at day 1
Drug: Placebo
Subcutaneous injections
Also known as: Tobacco leaf extract
Subcutaneous injections
Also known as: Water for injection
Change of smoking satisfaction
Success in achieving a 1 point reduction in the mCEQ "Smoking Satisfaction" subscale
Time frame: at Day 4
Change of smoking satisfaction
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
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
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?"
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
"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"
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?"
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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NFL Biosciences SAS