The Efficacy And Safety For Smoking Cessation Treatment

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A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF NICOTINEX (NiX) COMPARED TO PLACEBO FOR SMOKING CESSATION

Product: NiX

Protocol Number: A6012890

US IND Number: 76, 224

Development Phase: II

Created by: Manoj Amaraneni

1. INTRODUCTION
1.1 Indication
NiX is indicated as an aid to smoking cessation treatment.
1.2 Background and Rationale
Currently, about half of the 1 billion people smoking will eventually die from smoking related diseases1. Less than 5% of the smokers are able to stay abstinent for one year after a quit attempt, due to lack of effective therapies2. Nicotine
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Antibody levels were boosted by a second injection, and the vaccine was well tolerated. Based on these encouraging results, we are now planning to perform an exploratory phase II randomized trial in smokers between the ages of 18 and 70 years.
2. STUDY OBJECTIVES AND END POINTS
2.1 Objectives
The objectives of this phase II trial are
• To compare the clinical efficacy of NiX to placebo in smokers willing to quit.
• To evaluate the safety of NiX in healthy smokers.
• To determine the immunogenicity of NiX.
2.2 End points
Efficacy
• Continuous abstinence will be assessed at 6 months (week 24) after the prime dose. Assessment will be based on the measurement of exhaled carbon monoxide (CO) and urinary cotinine at each visit and self-reported number of cigarettes smoked during that time interval. A participant with a CO level of 10 ppm at screening.
• Individuals with negative urine screening tests for drug addiction (Opiate, Cocaine, Cannabinoids, Alcohol, Methamphetamines).
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• Females who are not of childbearing potential and who are not nursing can be included. Females who are of childbearing potential may be included provided that they are not pregnant, not nursing, and who meet all of the following criteria:
 Are instructed and agreed to avoid pregnancy through 30 days after the last
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