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
…show more content…
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
Nicotine is addictive! Most smokers use tobacco regularly because they are addicted to the nicotine. You can be addicted to the nicotine in a physical and physological addiction. Addiction is characterized by compulsive drug seeking and use, even if they are in the risk of health problems. It is well documented that most smokers identify tobacco as harmful and express a desire to reduce or stop using it, and nearly 35 million of them make a serious attempt to quit. Unfortunately, 7% of those who try to quit in their own achieve more than 1 year of abstinence; most relapse within a few days of trying to quit. Some of the other factors besides nicotine addictive properties include its high level of availability, the small number of legal consequences of using the tobacco, and the advertising methods used by companies. What most people do not realize is that the
The smoking habit is the principal cause of illness, disability and death around the world. More than five million of people in the world die due to smoking habit every year. If we don’t take care of this in 2030 the amount will be ten million. Seven million of these deaths would be in poor countries.
Of the roughly 42 million adults in the US that use tobacco, nearly 69% of smokers want to quit and more than 42% of those wishing to quit will make the attempt through various methods(1). These methods range from the "cold turkey" method, nicotine replacement therapy, behavioural therapy and even medicine. Each method has it's unique strengths and weaknesses as well as varying success rates. There are many reasons to quit and many ways in which to do so, either with methods that involve slowly weaning off of nicotine, like gums and patches from replacement therapy, to nicotine-free methods which require support from various sources.
Less than 10 percent of people can quit cold turkey. In the journal Tobacco Control, researchers found that smoking cessation drugs are no more effective than quitting cold turkey. This means that nicotine replacements are only helpful for a small fraction of smokers. For even these people, it was just as effective to quit cold turkey.
E-cigarettes have exploded onto the scene in the past three years. Whole stores dedicated to these devices have opened their doors to the public and business is thriving. E-cigarettes are battery-charged devices that have an atomizer, or heating element, in them to vaporize liquid nicotine. The user is able to inhale this vapor and get the nicotine without the other 4,000 chemicals present in tobacco cigarette smoke (Schroeder). Nicotine is a chemical that is produced by the tobacco plant. People have discovered that by smoking the leaves of a tobacco plant the nicotine in the leaves is delivered into the bloodstream. Nicotine by itself is not an awful drug as far as drugs go, although it is highly addictive, it is the tar in cigarettes that does so much damage. Tobacco use remains the number one preventable cause of death in the U.S. with 480,000 Americans dying prematurely from tobacco related disease. Kicking this habit remains difficult for most (U.S. Department of Health and Human Services). Mark Twain once wrote “It’s easy to quit smoking, I’ve done it hundreds of times.”
Researchers and doctors all over the world constantly discuss smoking problems. There is an incredible amount of information offered to people who fight the desire to light a cigarette, on a daily basis. But, as any drug, smoking is difficult to be forgotten, even with all the issues it brings.
Smoking cessation: The status is uncontrolled and patient is willing to try to quit smoking.
The first participants Vince, 21 from Romania between smoked 15-20 cigarettes a day. Since completing the study, Vince is the only one to have quit
Nicotine dependence remains a significant public health concern (Rep., 2011). Cigarette smoking is the leading preventable cause of mortality in the United States, accounting for approximately 1 out of every 5 deaths. On average, smokers die 13 to 14 years earlier than nonsmokers. Additionally the estimates for average annual smoking-attributable productivity losses are $96.8 billion and the total economic burden of smoking is approximately $193 billion per year (USDoHaH, 2000). Despite the availability of therapeutic options for smoking cessation, relapse rates remain high (Piasecki, 2006; Pollak et al., 2007). Therefore, there is a need for new, effective, strategies to assist cigarette smokers achieve abstinence.
When an individual stops taking the drug, the individual goes through withdrawal symptoms such as irritability, frustration or anger, anxiety, dysphonic or depressed mood, restlessness, difficulty concentrating, insomnia, decreased heart rate, and increased appetite. The short and long term effects of this drug have no difference because Gardner (2009) explains, "A youth who was able to keep withdrawal in check by smoking one cigarette every few days finds that, over time, he or she must smoke at more and more frequent intervals to keep withdrawal in check" (Gardner, 2009 ). So, the individual just needs to smoke enough nicotine and will gradually become addicted to the repeated exposure to nicotine. In fact, Gardner also mentioned "It can vary from many days in length in novice smokers, to just a few minutes in smokers with advanced dependence." (Gardner, 2009 ). Gardner brings in a very important point that with enough exposure to nicotine there isn't a difference between the short and long term effects of taking nicotine because just a certain amount can have an individual addicted to
Fact: cigarette smoke kills on average 1,300 people everyday. That’s over 480,000 deaths each year, even worse nearly 50,000 die annually from inhalation of secondhand smoke. Over 16% of Americans fall to the addition of nicotine (CDC). Although that number is declining, it still needs to fall, and there is one safe and effective way to do so. Using smokeless tobacco to wean off of an addiction to nicotine is safe and effective. It is proven through real life trials. Some even in your own community. Also the risk of getting oral cancer is comparably less from smokeless tobacco than from cigarettes. Finally nicotine levels can be altered on vapor products. This can help smokers wean off the addiction. Smokeless tobacco is safer than regular
We know this statement and we see this in advertisements, in slogans, in posters and televisions everywhere and yet smoking still the leading cause of death in America. According to Centers for Communicable diseases, 2017, smoking is still the No. 1 cause of preventable death in the United States. It kills more people than infectious disease, abuse, firearms, obesity and traffic accidents. Some people do not believe that smoking is harmful to them. Some people do not notice the harm at first and by the time they notice the effects, they are addicted to it already. That is why the Word Health Organization calls it as “gradual killer”. Lastly, according to Sherry McKee, the director of Yale Behavioral Pharmacology Lab, “Most of the smokers think that they can just quit easily at any time and nearly all believe that they won’t be long-term smokers”. These are some of the knowledge gaps in tobacco use.
would like to discuss replacement therapy for tobacco, and the helpful ways of quitting, there are different ways to quit smoking and kicking that nasty habit, to increase your life term. According to the CDC Tobacco use can lead to tobacco/nicotine dependence and serious health problems. Quitting smoking greatly reduces the risk of developing smoking-related diseases and early death. It can lead to lung cancer and many other types of cancer and risk for heart disease, stroke, and peripheral vascular disease (narrowing of the blood vessels outside your heart). (, 2015) There have been different types of therapy to reduce the use of nicotine and tobacco use. Such as medications that’s been approved by your PCP, nicotine patches, and Hypnosis.
First i would like to start with a hand raised greeting. Next I’ll tell you how have my commitments and challenges being gone for those couple of weeks. I’m sure you already guess how hard it was, since one of my commitments was to quit smoking cigarettes. Well, to be honest this past two weeks were very hard . Because as we all know the hardest thing to in life is to quit a habit or an addiction, because it's hard for our brain to function normally without the nicotine or the addiction you have. Especially if you have been doing it for a long time. For this purpose i planned to quit smoking by the help of nicotine-gum. Because i couldn't completely stop without a replacement for my addiction to
Nicotine use is a leading preventable cause of death in the world, directly and indirectly responsible for 440,000 deaths per year. The health problems that result in tobacco use tally an annual of $75 billion in direct medical costs (Slovic 36). That money spent on medical problems for smokers should be used to pay for more important things in our society such as schools, libraries, childcare, etc.