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Nicotine Replacement Therapy Backgrounder

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This footnoted backgrounder covers the following topics about stop smoking Quit Aids:

What is NRT & how does it work?
History of NRT
Choosing an NRT
nasal spray
Benefits of smoking cessation
The role of NRT in smoking cessation
Safety and efficacy of NRT
Where to go for additional information

Nicotine Replacement Therapy (NRT) BackgrounderTop

     Nearly 40 years ago, the U.S. Surgeon General first warned the American public about the dangers of smoking, citing smoking cessation as the “single most important step that smokers can take to enhance the length and quality of their lives.” Since then, the movement to educate people about the dangers of smoking has escalated to include warning labels on cigarette packs, moves to ban smoking in many public places and propositions to implement cigarette tax hikes in numerous cities and states. Yet, despite the strides that have been made over the past forty years, 25 percent of all American adults still smoke, resulting in the premature death of almost half a million people each year, and contributing to serious health risks for many others.
     These staggering numbers are no surprise, as smoking cessation is a difficult process. Although 70 percent of the current 50 million smokers in the United States are interested in quitting,1 many face nicotine cravings throughout their quit attempts and sometimes give up too soon. Many smokers think that willpower alone is enough to kick the habit. Pharmacists and health care professionals agree that smokers should not become discouraged if they do not kick the habit on their first quit attempt. It is quite common for smokers to make anywhere from three to six quit attempts before achieving success. Furthermore, the introduction of nicotine replacement therapies (NRT) into the smoking control market has increased smokers’ chances of quitting.

What is NRT and how does it work?Top

     Nicotine replacement therapies (NRT) are medications that provide smokers with a temporary alternative source of nicotine to help reduce cravings for cigarettes and also reduce withdrawal symptoms such as irritability, difficulty in concentrating, anxiety and restlessness that are associated with smoking.
     NRT can accomplish this by providing safe, controlled doses of medicinal nicotine without harmful tars and toxins in cigarette smoke.2 By addressing the physical addiction, using an NRT aid such as the patch, gum or lozenge allows a person to focus on the behavioral and lifestyle changes that he or she needs to make in order to lead a smoke-free life. There currently are five NRT products to help smokers quit – a transdermal patch, nicotine polacrilex gum and nicotine lozenge, which are available OTC, and a nasal spray and inhaler, which are available with a prescription. NRTs allow smokers to gradually reduce their nicotine intake over the recommended course of therapy, thus decreasing their dependence on nicotine slowly, the way physicians and pharmacists recommend.
     In general, NRTs have been shown to double a smoker’s chances of quitting versus “cold turkey,” or unassisted quitting, which is still the most commonly used method.2 Experts agree that smokers who either gradually cutback on the number of cigarettes they smoke or try to quit “cold turkey,” relying solely on willpower, rarely achieve success in quitting. In fact, studies have shown that after six months, 97 percent of “cold turkey” quitters usually start smoking again.
     While NRT helps quitters cope with the physical aspects of addiction, it should be combined with behavioral support methods that can address the psychological component of smoking to optimize and increase the chance of success. Without support, about one-third of quitters relapse within 24 hours, and after 48 hours, two-thirds resume smoking. The sheer physical and psychological discomfort of quitting can overwhelm even the smokers most determined to quit. That’s why Nicorette® nicotine gum, NicoDerm CQ nicotine patch and the Commit® nicotine lozenge offer users free enrollment Committed Quitters®, the only personalized behavioral support program that has been clinically proven to increase a smoker’s chance of quitting by up to 26 percent when paired with NicoDerm CQ, and by up to 50 percent when paired with Nicorette . Additionally, studies suggest that receiving support from family and friends, or “quitting together” also is critical in helping smokers stay motivated and can increase a smoker’s chances of quitting for good.

The History of NRTTop

     NRT first hit the U.S. smoking cessation market in 1984, when the prescription-only Nicorette nicotine gum was introduced as the premiere treatment for smokers trying to quit. The launch of the prescription-only NicoDerm CQ nicotine patch followed in 1991. In 1996, the U.S. Food and Drug Administration approved Nicorette and NicoDerm CQ for over-the-counter (OTC) sale, subsequently increasing the number of successful quit attempts. In October 2002, the FDA approved the newest form of NRT – the Commit nicotine lozenge.
     According to a study of U.S. census data, since NRTs have become available as non-prescription treatments to help Americans stop smoking, the number of smokers attempting to quit has significantly increased to nearly 40 percent. Researchers at the University of Pittsburgh found that attempts to quit smoking spiked concurrently with the introduction of the nicotine patch in 1993, then declined as use of prescription-only products reached steady-state. However, after the nicotine gum and patch were reclassified as OTC products in 1996, there was a substantial increase in quitting behavior. The findings add to the scientific evidence that ensuring easier access to OTC stop smoking products like Nicorette, NicoDerm CQ and Commit will not only increase the number of smokers attempting to quit, but also will positively impact overall U.S. public health.

Choosing an NRTTop

     Choosing an NRT should be a decision based on an individual’s own smoking style, personal goals and lifestyle. Almost three out of four smokers are interested in quitting, and what works for one may not work for another. Smokers also should consider factors such as intensity and timings of cravings, daily lifestyle and sources of support available, because not all NRTs are created equal. In fact, there are important differences among the available therapies.


     Nicotine polacrilex gum, such as GlaxoSmithKline Consumer Healthcare’s Nicorette, provides fast-acting craving control, allowing a user to manage his or her dosage of nicotine over the course of treatment. Nicotine gum, which is available without a prescription, is recommended for individuals who smoke at irregular intervals during their quit attempt and want to control how much nicotine they use, as well as when they use it.
     When used as directed, sugar-free Nicorette gum provides a lower level of nicotine to a user’s blood than cigarettes. Smokers should try to chew the same number of Nicorette pieces each day as scheduled, but when confronted with a particularly difficult craving, smokers are encouraged to chew an additional piece to help combat the craving. Nicorette product packaging instructs users to chew each piece very slowly several times, and then “park” it between the cheek and gum. This allows the nicotine to be absorbed by the lining of the cheek. Nicorette is available in two strengths: 2mg (for individuals who smoke 24 cigarettes or fewer daily) and 4mg (for individuals who smoke 25 cigarettes or more daily). Starter kits contain 110 pieces of gum, approximately two weeks of initial therapy, and refills contain 48 pieces, approximately one week of therapy. The user gradually reduces the daily dose of Nicorette, becoming nicotine-free in 12 weeks. Unlike generic nicotine gum, Nicorette is available in three flavors – original, mint and orange.


     The nicotine transdermal system such as GlaxoSmithKline Consumer Healthcare’s NicoDerm CQ nicotine patch, features a special rate-controlling membrane that delivers steady levels of nicotine throughout the day to reduce cravings.9 The nicotine patch, which is available without a prescription, begins working within 15 to 30 minutes of adhesion. People who smoke at regular intervals and want once-a-day convenience are recommended to try and quit with the NicoDerm CQ nicotine patch. Smokers have the option of wearing the NicoDerm CQ patch either 16 or 24 hours each day.
     NicoDerm CQ is the only patch to offer six weeks of initial therapy followed by four weeks of step down therapy. Smokers who smoke more than 10 cigarettes a day start at the 21mg dose for six weeks; then follow with the 14mg patch for two weeks; and the 7mg dose for the final two weeks of therapy. This simple step down program gradually reduces a smoker’s dependence on nicotine over a 10-week period. Smokers who smoke 10 cigarettes or less a day should use the 14mg dosage for six weeks and 7mg for the last two weeks. Unlike generic transdermal patches, NicoDerm CQ is available in opaque and clear.


     The newest, FDA-approved, OTC NRT products to hit the market, GlaxoSmithKline Consumer Healthcare’s Commit nicotine lozenge, provides smokers with craving fighting medicine to help them control cravings and to manage their quit attempts.9 The Commit lozenge goes to work after a smoker places it in his/her mouth, effectively reducing cravings by delivering craving-fighting medicine fast. It is recommended that during the first six weeks of his/her quit attempt, an individual should take one lozenge every one-to-two hours. The quitter uses fewer and fewer lozenges during the 12-week program, until he/she is completely nicotine-free.
     Commit also offers users a unique new quitting tool called “Time To First Cigarette” (TTFC) that allows smokers to select the strength of medication for their quit attempt based on whether or not they smoke their first cigarette within 30 minutes of waking up in the morning. Smokers who smoke their first cigarette within 30 minutes of waking should use the 4 mg dose. Smokers who smoke their first cigarette after 30 minutes of waking should use the 2 mg dose. The Commit lozenge is available in 72- and 168-count packs and will be introducing a 48-count pack in October 2003. Commit includes a comprehensive user’s guide that explains the process of quitting, how the lozenge works, the TTFC dosing method, specific tips for quitting and advice about staying smoke-free.


     The nicotine inhalation system helps control a smoker's craving for cigarettes while also addressing the behavioral component of smoking -- the hand-to-mouth ritual.11 It is available by prescription only. Packaged in a plastic tube that contains a nicotine-filled cartridge, the inhaler provides smokers with a low dose of nicotine vapor when inhaled. The nicotine is then absorbed into a smoker’s mouth and upper respiratory tract, as opposed to the lungs. The nicotine inhaler lets smokers control the amount of nicotine they get when the urge to smoke hits, but in a less concentrated dose than the amount of nicotine that is found in cigarette smoke.


     Nicotine nasal spray is a unique form of NRT in that delivers nicotine quickly to the bloodstream as it is absorbed through the nose. Nasal spray provides immediate relief of withdrawal symptoms and offers smokers a sense of control over nicotine cravings. Generally, it should not be used for longer than six months, tapering the dose at the end of three months. The nicotine nasal spray is available by prescription only and comes in 10-mL spray bottles (100 mg nicotine, 10 mg/mL). Each 10-mL bottle contains 100 mg of nicotine, about enough for 200 sprays. At the minimum dose, one bottle should last about 12 days; at the maximum dose, the bottle will last a little over two days.

Benefits of Smoking CessationTop

     There are many reasons for smokers to quit. Beyond smoke-stained teeth, premature wrinkles and sexual dysfunction, smoking is associated with many serious health risks, including heart disease, cancer and chronic obstructive pulmonary diseases (COPD). Regardless of age or smoking history, there are advantages to quitting smoking. According to the American Lung Association, twenty minutes after taking his or her last puff, a smoker’s blood pressure and pulse begin dropping back to normal; within one year after quitting, a smoker’s risk of a heart attack is decreased by 50 percent; and after 10-15 years of being smoke-free, an ex-smoker’s risk of lung cancer drops to one-half that of a smoker’s.
     In addition to significantly improving their health, smokers also should be motivated to quit because of the money that they can save by kicking their addiction. The average cost of a full stop smoking therapy is equivalent to what a smoker spends buying a pack of cigarettes per day over the same period of time.9

The Role of NRT in Smoking CessationTop

Over the past forty years, the medical community has come to better understand the complexity of the smoking cessation process. Subsequently, smoking is now considered a chronic disease among health care professionals and government officials. Stop smoking treatments are now viewed by the medical community as not only clinically effective in helping smoker’s quit, but also as cost-effective relative to other medical and disease prevention interventions.2 Health care insurers and purchasers now are being encouraged to cover behavioral counseling and pharmacotherapeutic treatments, such as NRTs for smoking cessation, just as they do for treating other chronic conditions.

Safety and Efficacy of NRTTop

     Over 100 clinical studies and extensive use over decades have proven that NRT products are safe and effective when used as directed.7 In fact, the U.S. Public Health Service’s smoking cessation guideline, Treating Tobacco Use and Dependence, released in June 2000, recommends NRT as first-line therapy for quitting,2 as they “increase significantly rates of long-term smoking abstinence.”
     Tobacco smoke, on the other hand, contains at least 69 known carcinogens , plus many other toxins, such as carbon monoxide, arsenic and ammonia as well as substances that can trigger heart disease, cancer, emphysema, chronic obstructive pulmonary disease (COPD) and many other potentially life-threatening diseases.2
     Certain populations should seek the advice of a health care professional prior to beginning NRT. These include people under the age of 18; people with heart disease, an irregular heartbeat or those who have had a recent heart attack; people with high blood pressure not controlled with medication; people taking medication to treat depression or asthma and women who are pregnant or nursing.9 In these cases, a physician will determine whether NRT is appropriate. However, it is important to note that under no circumstances should smokers continue to smoke or use other nicotine-containing products when using their selected method of NRT.9

Where To Go For Additional InformationTop

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