Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO)
NCT06091826 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2023-10-19
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.
Conditions
- Smoking Cessation
- Nicotine Dependence
Interventions
- DRUG
-
NFL-101
Subcutaneous injections
- DRUG
-
Subcutaneous injections
Sponsors & Collaborators
-
NFL Biosciences SAS
lead INDUSTRY
Principal Investigators
-
Yves Donazzolo, MD · Eurofins Optimed
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-21
- Primary Completion
- 2023-09-15
- Completion
- 2023-09-30
Countries
- France
Study Locations
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