Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-02-15
2003-12-09
Criares, Theodore J. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S813000, C424S048000, C424S440000
Reexamination Certificate
active
06660754
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a method for gradually reducing or eliminating an individual's tobacco usage habit, in particular smoking, as well as the associated nicotine dependence that is created by tobacco use.
The idea of applying reduction strategies to smoking cessation has been explored in the development of smoking cessation methods over the last twenty years. However, reduction as an end goal or as a means to cessation has received very little attention in recent years. In fact, these methods are not even included as treatment options in the Agency for Health Care Policy and Research (AHCPR) Centers for Disease Control and Prevention Smoking Cessation Guideline, the authoritative review that outlines the standard of care for smoking cessation. See U.S. Department of Health and Human Services, AHCPR Publication No. 96-0692, Apr. 1996.
Innovative treatments of smoking reduction or cessation are significantly lacking. Most smoking control methods are cessation methods and are undertaken without the aid of pharmacological or behavioral therapy, in part because the quitting approaches associated with these therapies are not consistent with a smoker's preferred quitting approach. Recent research on smoker's attitude toward quitting shows that in comparison to abrupt cessation, many smokers who are interested in quitting smoking prefer to quit by gradually reducing the amount they smoke. Recent studies demonstrate that gradual reduction strategies can succeed without pharmacological therapy. These strategies, however, involve intensive behavioral intervention and always have as their goal smoking cessation rather than reduction only. For example, see Cinciripini et al., “The Effects of Smoking schedules on Cessation Outcome: Can We improve on Common Methods of Gradual And Abrupt Nicotine Withdrawal,”
Journal of Consulting and Clinical Psychology
, Vol. 63, No. 3, pp. 388-399 (1995), comparing two gradual reduction quitting methods to quitting “cold turkey.” The gradual reduction methods of quitting described in Cinciripini et al. included (1) progressively increasing inter-cigarette intervals and (2) gradually reducing the number of cigarettes smoked without changing the inter-cigarette interval. All methods included the use of cognitive-behavioral relapse prevention training, and were without pharmacological therapy such as an alternative nicotine source.
These efforts to quit by gradual reduction without nicotine replacement often fail. It has been suggested that one reason that gradual reduction fails is because tobacco users are progressively deprived of nicotine and consequently experience nicotine cravings and withdrawal which deter quitting or further reduction.
One method that combines reduction with the use of nicotine replacement therapy is described in U.S. Pat. No. 5,055,478. In one embodiment, the method described in this patent includes the steps of first recording over an approximately two week period, the times during which each cigarette is consumed. These time periods of smoking are referred to as consumption periods, which are not necessarily consecutive in time. Then, tobacco consumption gradually is decreased by replacing in an increasing number of consumption periods (up to 16 consumption periods) over a two week period, the use of tobacco with an alternative nicotine source such as Nicorette® nicotine-containing chewing gum (2 mg nicotine dosage), until no further tobacco is consumed. The nicotine in each piece of gum is a substitute for all the tobacco consumed during a consumption period. This level of consumption of the alternative nicotine source is maintained for approximately four weeks. During this four week period, while the individual is still receiving nicotine through the alternative nicotine source, the individual addresses the social and psychological reasons for smoking. After the four week period, the alternative nicotine source is eliminated at a rate of one consumption period per week for approximately 14-16 weeks, until no further alternative nicotine source is consumed.
A second method described in U.S. Pat. No. 5,055,478 includes an initial step of recording for approximately two weeks an individual's normal tobacco consumption pattern to identify the times of day during which tobacco is consumed, and the amount of tobacco consumed during these periods. Each day is then broken down into consumption periods of one hour each. Then, all tobacco consumption is abruptly stopped and an alternative nicotine source (approximately 1.5 to 1.75 mg. per consumption period) is administered for a period of about two weeks. As with the first method above, following cessation of smoking but while the individual is still receiving nicotine through the alternative nicotine source, the individual addresses the social and psychological reasons for smoking. The user then gradually decreases administration of the alternative nicotine source down to a lower level of approximately 1 mg per consumption period for approximately 10-18 days. This is done by administering the lower dosage alternative nicotine source during an increasing number of consumption periods until the lower dosage is consumed during all consumption periods. After reaching the lower dosage in each consumption period, the lower dosage alternative nicotine source is administered for about two weeks. Then, the user gradually eliminates consumption of the alternative nicotine source by eliminating consumption of the source during an increasing number of consumption periods (one per week) a until no alternative nicotine source is consumed.
Another method closely related to the methods described in U.S. Pat. No. 5,055,478, combines smoking reduction with the use of nicotine replacement therapy. This method is described in Cooper et al., “New Hope for Heavy Smokers—The Cooper/Clayton Method to Stop Smoking”. In this method, after the initial two week recordation phase, an alternative nicotine source is substituted for all consumption periods, and the individual immediately stops smoking. The remainder of the method is similar to the above method but elimination of the alternative nicotine source is to a maintenance level which is about one-third of the first maintenance level, followed by gradual reduction as in the final phase described above. In this method, the individual receives intensive person-to-person psychological intervention.
Yet another method of smoking cessation is described in a publication by SmithKline Beecham entitled “Nicorette® Committed Quitters™ Calendar and Smoking Cessation Service. In this method, the user abruptly stops smoking and consumes one piece of Nicorette® gum (2 mg. or 4 mg. dosage, generic name nicotine polacrilex gum) every 1-2 hours consuming no more than 24 pieces per day for a six week period. In week seven the individual cuts back to consuming one piece of Nicorette® gum every two hours and continues at this level for three weeks. In week 10, the individual cuts back to one piece of Nicorette® gum every four hours. After week 12, the individual stops using Nicorette® gum. During the twelve week period, the individual records the number of pieces of Nicorette® gum chewed and some activities the individual plans to do each day to help cope with not smoking. The calendar also provides helpful hints for dealing with cravings and the psychological aspects of quitting smoking, and a reminder of the amount of time invested in quitting.
SUMMARY OF THE INVENTION
This invention is an improved method for reducing or eliminating tobacco usage, particularly smoking, and the nicotine dependency associated with tobacco usage by gradually decreasing an individual's tobacco usage over a time period while replacing nicotine from tobacco with an alternative nicotine source.
REFERENCES:
patent: 5055478 (1991-10-01), Cooper et al.
patent: 5488962 (1996-02-01), Perfetti
Cinciripini et al., “The Effects of Smoking Schedules on Cessation Outcome: Can We Improve on Common Methodsof Gradual and Abrupt Nicotine Withdraw
Kyle Theodore K.
Shiffman Saul
Criares Theodore J.
Furman, Jr. Theodore R.
Kim Jennifer
Kinzig Charles M.
SmithKline Beecham Corporation
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