METHOD OF SMOKING CESSATION

Abstract

A 12-week method of smoking cessation includes three phases. During the first phase, the subject is habituated to a breathing exercise. During the second phase, cigarette smoking is replaced with a source of nicotine and the breathing exercise. During the final phase, the amount of nicotine and the number of breathing exercises is gradually reduced. During Phases 1 and 2 the subject is provided with a breathing exercise capable of relieving an occasional craving for smoking.

Description

BACKGROUND OF THE INVENTION

According to the American Lung Association, cigarette smoking is the most important source of preventable morbidity and premature mortality worldwide. Smoking-related diseases kill an estimated 438,000 Americans each year, including those affected indirectly, such as premature babies of smoking mothers and victims of “secondhand” smoke. Smoking costs the United States over $167 billion each year in extra medical costs and lost productivity. About 8.6 million people in the U.S. have at least one serious illness caused by smoking. Smoking causes chronic lung disease, cardiovascular disease and stroke. Smoking may be a cause of several cancers (in addition to lung cancer) and has been linked to slowed healing of wounds, infertility and stomach ulcers. Smoking during pregnancy accounts for an estimated 20 to 30% of low birth weight babies, up to 14% of preterm deliveries, and some 10% of all infant deaths. Even apparently healthy, full-term babies of smokers have been found to be born with narrowed airways and curtailed lung function.

In 2004, an estimated 44.5 million, or 20.9% of adults were smokers. The annual prevalence of smoking has declined 40% between 1965 and 1990, but has remained unchanged thereafter. Smoking during pregnancy declined in 2003 to 10.7% of women giving birth, down 42% from 1990. Still, only about 30% of women who smoke, stop smoking when they find out they are pregnant.

Many factors make quitting smoking difficult. Nicotine is an addictive drug, which when inhaled in cigarette smoke, reaches the brain faster than drugs taken intravenously or orally. Besides the physical addiction, smoking is associated with many social activities. As a result, smoking is a notoriously difficult habit to break.

In 2003, an estimated 45.9 million adults were former smokers. Of the current 44.5 million smokers, nearly 72% reported that they wanted to quit smoking completely. However, quitting smoking is not an easy task.

DESCRIPTION OF THE PRIOR ART

There are various methods of breaking the smoking habit. Some methods involve medication alone. The simplest medication regimen involves nicotine in gradually diminishing doses. Nicotine can be administered as a patch or a lozenge. The goal of these slow-release preparations is to maintain the subject in the comfort zone by keeping the blood nicotine concentration constant throughout the day. Over several weeks of treatment, the blood concentration of nicotine is gradually lowered. For optimal results, nicotine can be administered by a combination of oral, transdermal and nasal routes, as described in the U.S. Pat. Nos. 5,834,011 and 5,016,652. Nicotine can also be replaced with its chemical analogs, such as 2-acetylpyridine (U.S. Pat. No. 5,336,680). Nicotine can be gradually replaced with an analog until no more nicotine is used, and then the analog is gradually withdrawn (U.S. Pat. No. 6,660,754).

More complex medications supplement nicotine with various vitamins, herbs and drugs. The popular drugs include antidepressants and muscle relaxants, as well as medications that reduce weight gain. There are also claims that sulfur compounds added to cigarettes and silver nitrate mouthwashes help eliminate cravings for nicotine.

Other methods of smoking cessation rely on behavior modification alone. For example, U.S. Pat. Nos. 5,055,478 and 7,028,693 teach calculating the number of cigarettes that the subject smokes daily. This number is divided over the waking hours. The subject then wears a beeper to keep track of when a cigarette can be smoked. Over time, the intervals between cigarettes become gradually longer until the habit is “broken”. In a different approach, U.S. Patent Application Publication No. US/2005/0112148 teaches psychological conditioning where the subject is allowed to smoke only in unfamiliar unpleasant locations. Eventually, the subject becomes “conditioned” to dislike and no longer crave the smoking experience.

There are a number of devices that help reduce cravings. For example, U.S. Pat. Nos. 6,458,149 and 6,179,864 teach a mouthpiece that relieves the craving for a cigarette in the user's mouth. U.S. Pat. No. 5,308,245 describes a squeezable handgrip the size of a cigarette box that is supposed to relieve the tension and anxiety associated with cravings. Finally, U.S. Patent Application Publication No. US/2002/0059939 teaches delivering nicotine replacement through a cigarette-size tube in order to create a familiar feeling of dragging on a cigarette.

Most commercial programs take a comprehensive approach to smoking cessation. This involves nicotine replacement together with some form of support. For example, U.S. Pat. No. 6,431,874 teaches a combination of hypnosis, education and nicotine replacement. The Mayo Clinic offers a program with psychological counseling, medication and a residential option (www.mayoclinic.org/stop-smoking). A program called “Final Smoke” (www.finalsmoke.com) combines the anti-craving medicine with a book and an “inspirational” audio recording. The American Lung Association (www.lungusa.org) offers a program called Freedom From Smoking (FFS®) that combines medication with education, psychological counseling and relaxation techniques. A Russian Patent No. RU2132203 describes a method combining psychotherapy, hypnosis and psychiatric medication with a gradual reduction in daily number of cigarettes and regular intake of carbonated water.

Although many smoking cessation methods are available, 20.9% of American adults and 22.3% of high school students still smoke. Most smokers trying to quit fail several times before they are able to break the habit. The Center for Nicotine and Smoking Cessation Research at Duke University reports that only 5% of smokers are able to quit on their own. The American Lung Association reports that an average person makes two to four attempts at quitting before they are able to stay smoke-free. On each subsequent attempt the Association recommends trying a different method. It is therefore desirable to have a variety of smoking cessation methods to motivate smokers to keep trying to quit.

SUMMARY OF THE INVENTION

The present invention is a method of smoking cessation that involves a combination of breathing exercises and nicotine replacement. The method also includes several ways of addressing urgent cravings for smoking.

DETAILED DESCRIPTION OF THE INVENTION

DEFINITIONS

The following terms are used in the description of the method.

• “Abatement Option”—a selected method of addressing cravings for nicotine. This may include switching to cigars or pipes, chewing tobacco or using nicotine replacement in the form of a pill, gum, patch or lozenge or other methods, such as chewing regular gum.
• “Daily Nicotine Intake (DNI)”—the amount of nicotine taken in daily through smoking and non-smoking sources.
• “Pseudo-Puffing Interval (PPI)”—an interval (usually in minutes) at which the exercise called Pseudo-Puff is performed.
• “Pseudo-Puff”—a breathing exercise described in the specification.
• “Sniper-Shot”—a method of addressing craving for smoking that involves performing a series of Pseudo-Puff exercises.

The present invention is a three-phase method. During the first phase “Phase 0” the subject learns and practices the main component of the method. The preparatory phase is followed by several weeks, usually eight weeks, of practicing the entire method. At the end of the last phase, the subject is no longer smoking tobacco and has no cravings for smoking. Furthermore, the subject is trained to address cravings for smoking should they appear.

Phase 0

During this phase the subject must accomplish three tasks: (1) learn a breathing exercise called “Pseudo-Puff”; (2) calculate the Pseudo-Puffing Interval (PPI) at which the Pseudo-Puff is to be performed during the day; and (3) prepare a nicotine Abatement Option, i.e. select the type and dosage of the nicotine replacement. Because Phase 0 is preparatory, the weeks of Phase 0 are not counted as the actual weeks of the program.

First, during Phase 0, the subject must learn the Pseudo-Puff. The exercise involves the following steps:

• • (1) From the looking straight ahead position, turn the head 90 degrees to the left, then take as deep a breath as possible through the nose;
  • (2) While holding the breath, turn the head slowly 180 degrees left-to-right, then forcefully exhale through the mouth; one should hold the breath for as long as one usually holds the smoke from cigarettes, cigars or pipes in one's lungs or mouth;
  • (3) Slowly turn the head 90 degrees to return to the straight-ahead position.

After learning to comfortably perform the Pseudo-Puff, the subject must learn how to incorporate the Pseudo-Puff into the daily routine. As the subject continues to smoke regularly, he must perform one Pseudo-Puff after each exhalation of cigarette, cigar or pipe smoke. This must be practiced for at least 28 consecutive days before moving to Phase 1 of the method.

Next, during Phase 0, the subject must determine the personal Pseudo-Puffing Interval (PPI). For this calculation, one needs the number of hours per day that one smokes and the number of cigarettes smoked per day. The ratio of cigarettes to smoking hours gives the number of cigarettes smoked per hour. Next, one must determine the average number of inhalations on each cigarette. Pseudo-Puffing Hourly Rate is a product of the number of inhalations and the number of cigarettes. Essentially, Pseudo-Puffing Hourly Rate equals the number of times the subject inhales cigarette smoke per hour. PPI, or Pseudo-Puffing Interval is found by dividing 60 minutes by the Pseudo-Puffing Hourly Rate. The following example illustrates the calculation of PPI:

• • A person smokes for 16 hours daily.
  • The person smokes 60 cigarettes per day.
  • The person smokes 60/16=(approx.) 4 cigarettes/hour
  • The person inhales 8 times on each cigarette.
  • Pseudo-Puffing Hourly Rate is 8×4=32 times/hour
  • PPI=60/32=(approx.) 2 minutes.

In other words, this person must perform a Pseudo-Puff every 2 minutes during the time that he normally smokes.

Finally, during Phase 0, the subject must choose a strategy to deal with nicotine cravings. This is called Abatement Option. One must choose a source of nicotine or a non-nicotine product. The method gives four choices: (1) cigars or tobacco pipes (alternative sources of nicotine for cigarette users only); (2) chewing tobacco or nicotine gum (for cigarette, cigar and pipe users alike); (3) non-nicotine gum; or (4) any other available medication or technique to address nicotine cravings.

If the subject chooses a nicotine substitute, one must determine habitual Daily Nicotine Intake (DNI). This is achieved by multiplying the daily number of cigarettes by the amount of nicotine in each cigarette. Nicotine content of a particular brand of cigarettes, cigars and tobacco can be found at www.erowideorg. For example, if a person smokes 60 cigarettes per day and the nicotine content is 2.1 mg per cigarette, DNI is calculated as follows:

DNI=60×2.1=126 mg per day

Phase 1

Phase 1 spans the first four weeks of the program (Weeks 1-4 of Phase 1). Phase 1 starts when the subject has developed a habit for Pseudo-Puff. However, Phase 0 must continue for at least 28 days. The subject should also have calculated the PPI (Pseudo-Puffing Interval) and the DNI (Daily Nicotine Intake). During Phase 1, the subject does not smoke any cigarettes but performs the Pseudo-Puff at the determined PPI throughout the time of day when he normally smokes. In the example above, the Pseudo-Puff is performed every 2 minutes for 16 hours, starting from the time when the subject usually lights his first cigarette.

At the same time, the subject follows the chosen Abatement Option for addressing cravings for nicotine. This involves taking the prescribed amount of nicotine (except on the non-nicotine option) and dealing with cravings for smoking.

It is expected that subjects will occasionally feel cravings for smoking during Phases 1 and 2. The method teaches special techniques, described below that help make the cravings pass.

During Day 1 of Phase 1, the subject tests whether his chosen DNI leaves him free of cravings for smoking. If the DNI is correct, the subject stays in the craving-free “comfort zone” while performing Pseudo-Puffs and using the chosen Abatement Option. When occasional cravings appear, the subject can handle them by using the prescribed technique. If the subject is not able to make the cravings pass, he must increase the DNI on the next day. In that case, the next day (Day 2) will be treated as Day 1.

No-Nicotine Option

Those who chose not to take any nicotine, either do nothing or chew regular non-nicotine gum. When cravings for smoking appear, such subjects must perform an exercise called “Sniper-Shot”. Sniper-Shot involves three steps: (1) performing a Pseudo-Puff; (2) waiting 5 to 15 seconds; (3) if the craving has not passed, performing steps 1 and 2 again. The rapid succession of Pseudo-Puffs is designed to eliminate the craving.

Cigar or Pipe Option

Cigarette smokers can use cigars or pipe tobacco as their source of nicotine. These subjects must perform the following at the PPI: inhale on the cigar or pipe, hold the smoke in their mouth, exhale and then perform a Pseudo-Puff. In the above example, where PPI was 2 minutes, every 2 minutes the subject starts with puffing or drawing on the cigar or pipe and then the Pseudo-Puff.

If cravings for smoking appear, a person on this option must reduce his PPI in 15-second increments, i.e. perform Pseudo-Puffs more often. In the above example, instead of performing a Pseudo-Puff every 2 minutes, the subject would do it every 1 minute 45 seconds. If the craving has not passed after the PPI has been reduced by a whole minute, the subject must increase the amount of nicotine (DNI). This can be done by choosing a different brand of tobacco, or simply holding the smoke in the mouth for a longer period of time.

Chewing Option

Those who chose to chew, use chewing tobacco or nicotine gum. These subjects must find an amount that they can chew at a comfortable pace, while still getting the DNI. At the same time, the subjects perform the Pseudo-Puff at the PPI.

If smoking cravings appear, the person on this option must first try to reduce the PPI in 15-second increments, i.e. perform the Pseudo-Puff more often. If the PPI has been reduced by a whole minute and the craving has not passed, the subject must increase the DNI by either chewing faster, or getting gum or chewing tobacco with higher nicotine content.

“All Others” Option

This category includes all non-chewing and non-smoking sources of nicotine such as, for example, lozenges and patches. A person in this category simply performs Pseudo-Puffs at the PPI. To address cravings for smoking, as in the prior options, one must first reduce the PPI. If that fails, one must increase the DNI by taking more lozenges or using a different patch.

After Day 1 of Phase 1 has been completed without any uncontrollable cravings for smoking, the subject must continue the program for Days 2-28 to complete Phase 1 of the program.

Phase 2

This phase usually spans four weeks, Weeks 5-8 of the entire program or Weeks 1-4 of Phase 2. During this phase, the subject gradually decreases the amount of nicotine (DNI) and increases the intervals between Pseudo-Puffs (increases the PPI). At the end of this phase the subject should be free from smoking cravings without the need for Pseudo-Puffing or nicotine. During Phase 2, the subject must continue using the same method of relieving smoking cravings that was used in Phase 1. In addition, the subject must perform the Sniper-Shot exercise whenever he feels a craving for smoking. In Phase 1, only subjects on the Non-Nicotine Abatement Option had to perform the Sniper-Shot. During Phase 2 and the Lifetime Maintenance, all subjects must perform the Sniper-Shot.

There are two tactics for Phase 2. For the first two weeks of Phase 2 (Weeks 5-6 of the entire program or Weeks 1-2 of Phase 2), the subject must choose one of the two tactics. The first tactic involves reducing the Daily Nicotine Intake (DNI) on the first day of the week. To remain craving-free, the subject may need to reduce the PPI, i.e. make more frequent Pseudo-Puffs. As the week goes by, the subject must try increasing the PPI in 1-minute increments, i.e. return to making fewer Pseudo-Puffs. DNI should be decreased in increasing increments. The sample calculation is provided below:

		Week	Starting
	Treatment	on the	habitual	Current %	Current
	Phase	program	DNI	nicotine	DNI
	Phase 1	1–4	126 mg	100%	126 mg
	Phase 2	5	126 mg	90%	113.4 mg
	Phase 2	6	126 mg	75%	94.5 mg
	Phase 2	7	126 mg	50%	63 mg
	Phase 2	8	126 mg	25%	31.5 mg
	Phase 2	9	126 mg	0	0

The second tactic for Phase 2 is to reduce the number of hours during which the subject practices the method. For example, if the subject was spending 16 waking hours performing Pseudo-Puffs and chewing nicotine gum, he should reduce the number of hours to 15. The “free hour” should be at the end of the day. During the free hour, the subject does not perform Pseudo-Puffs and does not chew gum. The subject must subtract at least one hour each week, so that by the end of Week 8 (Week 4 of Phase 2), the number of Pseudo-Puffing hours has been reduced by at least 5.

The remaining part of Phase 2 (Weeks 7-8 of the entire program or Weeks 3-4 of Phase 2) the subject must combine the two tactics. Each week the DNI is reduced according to the chart. At the same time, half-way through Week 3 of Phase 2 (Week 7 of the entire program), e.g. on Thursday, the subject must also add a free hour to the day. Starting Week 4 of Phase 2 (Week 8 of the entire program), the subject must add two free hours to the day, e.g. add one starting Tuesday and one hour starting Friday.

During the entire Phase 2 the subject stays in the comfort zone free of cravings for cigarettes by performing the Pseudo-Puff exercises and adjusting the PPI. Whenever cravings for smoking appear, the subject performs Sniper-Shot.

At the end of Phase 2 (Week 9 of the entire program) the DNI is reduced to zero, i.e. the subject is not taking in any more nicotine. If the subject experiences any craving for smoking, the subject should perform a Sniper-Shot exercise.

Sniper-Shot is a uniquely beneficial method of addressing cravings for smoking. It is known that people who quit smoking have a fairly high recidivism rate. Most chemical based methods of smoking cessation rely on the subjects “positive attitude” to withstand occasional cravings for smoking that may appear during the stresses of daily life. Alternatively, the subject must always remember to carry a supply of the nicotine substitute for such emergencies. In contrast, Sniper-Shot is free, always available and effective. Furthermore, Sniper-Shot is a beneficial breathing exercise that strengthens the lungs and contributes to their recovery from the damage done by smoking.

Without being restricted to a particular theory, the inventor offers a possible explanation of how Pseudo-Puff works. Pseudo-Puff may relieve cravings for smoking through classical (Pavlovian) conditioning. Normally, smokers inhale deeply, temporarily delivering additional oxygen to the brain. At the same time, smokers receive the nicotine that gives them pleasure. As a result, through conditioning, deep breathing becomes associated with pleasure. During Phase 0, the smoker performs a Pseudo-Puff after each puff on a cigarette, cigar or pipe. This conditions the smoker to associate Pseudo-Puff with the pleasures of smoking. Although Pseudo-Puff delivers no nicotine and is merely deep breathing, the smokers become conditioned to feeling pleasure from Pseudo-Puff as much as from an actual cigarette, cigar or pipe puff.

Claims

1. A method of treating smoking addiction in a human subject comprising the steps of:

taking a non-cigarette nicotine replacement;

at a predetermined rate, performing a breathing exercise;

gradually reducing the amount of said nicotine replacement taken; and

gradually reducing the frequency of said breathing exercise.

2. The method of claim 1, wherein said breathing exercise imitates said subject's breathing pattern while smoking.

3. The method of claim 2, wherein said breathing exercise involves holding said subject's breath for the same time as said subject habitually holds tobacco smoke.

4. The method of claim 3, wherein said breathing exercise comprises the steps of:

turning the head of said subject to face left;

inhaling deeply;

turning the head of said subject 180 degrees to face right; and

exhaling.

5. The method of claim 1, wherein the amount of nicotine, consumed daily as said replacement approximately equals the amount of nicotine habitually consumed by said subject through smoking.

6. The method of claim 1, wherein said breathing exercise is performed at approximately the same frequency as said subject habitually inhales tobacco smoke.

7. The method of claim 1 further comprising a step of habituating said subject to said breathing exercise prior to the performance of subsequent steps.

8. The method of claim 7 wherein said subject is habituated through continuously alternating inhaling tobacco smoke with performing said exercise.

9. A method of treating smoking addiction in a human subject over the course of twelve weeks comprising the steps of:

during the first four weeks, habituating a subject to a breathing exercise;

during the next four weeks, taking a non-cigarette nicotine replacement and performing said breathing exercise at a predetermined rate;

during the final four weeks, gradually reducing the amount of said nicotine replacement taken and gradually reducing the frequency of said breathing exercise.

10. The method of claim 9, wherein said breathing exercise imitates said subject's breathing pattern while smoking.

11. The method of claim 9, wherein said breathing exercise involves holding said subject's breath for the same time as said subject habitually holds tobacco smoke.

12. The method of claim 9 further comprising a step of treating a craving for smoking through a rapid succession of said breathing exercises.