NCT06091826

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: NFL Biosciences SAS · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	NFL-101	Subcutaneous injections
DRUG	Placebo	Subcutaneous injections

Timeline

• Start date: 2023-02-21
• Primary completion: 2023-09-15
• Completion: 2023-09-30
• First posted: 2023-10-19
• Last updated: 2023-10-19

Locations

1 site across 1 country: France