Drug – bio-affecting and body treating compositions – Chewing gum type
Reexamination Certificate
1999-12-15
2002-06-25
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Chewing gum type
C424S440000, C426S003000, C514S343000
Reexamination Certificate
active
06409991
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a method for relieving nicotine addiction and in particular to a kit and associated method in which symptoms of nicotine withdrawal syndrome are relieved while addressing the associated oral cravings for sweets.
BACKGROUND
Cigarette smoking continues to be the major preventable cause of death in the United States resulting in nearly 400,000 deaths per year due to cancer and cardiovascular disease. Despite the potential adverse health effects, the vast majority of cigarette smokers are unable to cease smoking. The lack of smoking cessation success is thought to be related to the tobacco withdrawal syndrome or tobacco abstinence syndrome that most smokers experience during their attempts to quit.
As many as one third of heavy smokers who are now 35 years old will die before age 85 of diseases caused by their smoking. The estimated cost of health problems associated with smoking, including medical care, absenteeism, decreased work productivity, and accidents is estimated to be $56 billion per year.
Cigarette smoking has many adverse consequences. In addition to being one of the major preventable causes of death in the United States from lung cancer and coronary artery disease, smoking has been implicated in cancers of the larynx, pancreas, bladder, kidney, and cervix. Smoking during pregnancy has been shown to increase the incidences of still births, neonatal deaths, premature delivery, low birth weight, and fetal death.
Smoking also has adverse impacts on breast feeding: it reduces milk production, decreases the milk's vitamin C content, and increases colicky pain and diarrhea in the breast-fed infant. Hospital admissions for bronchitis and pneumonia are twice as high for children whose parents smoke. These children also have increased risk of cancer later in life.
Given the consistent demonstration of dose-dependent relationships between smoking and disease, evidence of reductions in health risks following smoking cessation, and experimental studies documenting carcinogenic effects of tobacco smoke in animals, few scientists question the causal nature of the relationship between smoking and illness.
Despite this, approximately 26% of the adults in the United States continue to smoke. Very few effective strategies for smoking cessation have been developed, and up to 80% of smokers who initially stop smoking will relapse within six months to a year. The potential success of smoking cessation efforts is impeded, in part, by the fact that many of the advantages of continuing to smoke are immediate while the disadvantages of smoking are delayed and probabilistic.
The lack of smoking cessation success is attributed, in part, to nicotine addiction. One third to one half of occasional cigarette smokers graduate to maladaptive use and to physical dependence on nicotine. In fact, addiction to nicotine, as described in past U.S. Surgeon General's reports on smoking, is widespread, with over 50 million smokers in the United States alone. As a result of the effects of nicotine, most tobacco-dependent persons never achieve lasting abstinence, and half of all smokers die prematurely of tobacco-related disease.
Greater understanding of the adverse health effects of tobacco consumption has led to an increase in research on the nature of nicotine addiction and its treatment.
Nicotine is a water-soluble and lipid-soluble base. When delivered in alkaline cigar and pipe smoke, smokeless tobacco, and some European cigarettes, nicotine is readily absorbed across the mucosal membranes of the mouth and nose, which explains the rapid absorption associated with smokeless tobacco. Cigarette smoke is acidic and must be inhaled to be absorbed effectively in the pulmonary alveoli, where absorption is rapid.
From the lung, nicotine is absorbed into alveolar capillary blood and carried to the heart and then to the brain and other organs. All widely marketed cigarettes deliver sufficient nicotine to establish and sustain dependence readily. Cigarettes contain 6 to 11 mg of nicotine, of which the smoker typically absorbs 1 to 3 mg, irrespective of the nicotine-yield ratings provided by the tobacco company. The typical pack-per-day smoker absorbs 20 to 40 mg of nicotine each day, achieving plasma concentrations of 25 to 35 mg per milliliter by the afternoon. The plasma half-life of nicotine is approximately two hours.
The effects of nicotine that are associated with dependence include increased expression of brain nicotine receptors, changes in regional brain glucose metabolism, electroencephalograph changes, the release of catecholamines, tolerance, and physiologic dependence. These effects increase the compulsion to smoke by producing positive reinforcement (with the administration of nicotine) and withdrawal symptoms (with abstinence).
Withdrawal symptoms are intensified by abrupt abstinence from nicotine, beginning within a few hours, peaking within a few days, and typically lasting for four weeks, although there is considerable variability. Most people who quit smoking relapse within one week, when withdrawal symptoms are at or near their peak. Thereafter, the correlation between withdrawal symptoms and relapse is weak.
For those who are unable to give up smoking completely, various forms of nicotine-replacement therapy have been suggested. Of the pharmacological approaches to aiding nicotine use cessation, nicotine replacement, e.g., via transdermal nicotine patches or nicotine gum, is the most widely used.
Nicotine-containing chewing gum is available commercially and has provided a satisfactory substitute for tobacco-smoking for some people. Nicotine gum and other transdermal nicotine delivery systems decrease abstinence discomfort, especially anxiety, decreased memory, and irritability. Furthermore, they increase the craving for sweets.
As such, one immediate consequence of quitting smoking is weight gain. There is overwhelming evidence that smoking cessation leads to weight gain. Various studies have shown that people who quit smoking gain weight. It was reported that smokers weighed an average of 7.13 lb (range: 2.36-14.99 lb) more than nonsmokers. Smokers who quit in the longitudinal studies gain an average of 6.16 lb (range: 1.76-18.07 lb) following cessation. A popular, but erroneous, statistic is that only about one third of smokers will gain weight following cessation, while one third stay the same weight and one third lose weight. Unfortunately, recent studies have confirmed that the overwhelming majority of smokers gain weight following cessation.
Unfortunately, weight gain following smoking cessation appears to be a significant reason for continued smoking. At least one third of smokers report that they continue to smoke primarily for the weight-related benefits. It also appears that some individuals, particularly females, are likely to initiate smoking because of the weight reduction properties of cigarettes. Weight-related concerns also appear to be an important predictor of success in both worksite and pharmacologic intervention.
Although weight and weight-related concerns appear to be a major reason for continued smoking, it may be surprising to learn that there are few effective treatment methods for reducing this inevitable weight gain. Behavioral methods, which are effective in weight control in general, have not yet been developed to the extent where they can prevent, or even reduce, postcessation weight gain. In terms of pharmacological intervention.
The most effective pharmacological approach thus far has been nicotine substitution therapy, using nicotine gum, or other nicotine forms, to slowly wean individuals from their addiction to nicotine and craving for tobacco products containing same. The problem with nicotine substitution therapy is that it involves the administration of the psychoactive constituent of tobacco indicated as a contributor to the diseases for which smoking is a risk factor. Nicotine substitution, additionally, must be tapered leading to nicotine withdrawal. Along with the tobacco cravings, the patient wi
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