A recent randomized, double-blind, placebo-controlled study conducted in Denmark has shown that the effectiveness of nicotine polacrilex (Nicorette) is directly related to dosage.* This result contrasts with those of other studies of nicotine gum, many of which have suggested that nicotine is no more effective than placebo. The authors of this study attribute high abstinence rates to the use of sufficient nicotine dosages.
At the start of the study, gum containing nicotine polacrilex was given to 60 highly dependent smokers; gum containing 4 mg per piece was given to 27 study subjects, and gum containing 2 mg per piece was given to the 33 remaining subjects. In addition, 113 patients with medium-to-low dependence were given 2-mg nicotine gum. Placebo gum was given to 53 smokers with medium-tolow dependence. Duration of the study was a maximum of two years. Initially, the subjects were instructed to use 6-14 pieces per day, with gradual reduction over the following months. All smokers took part in group counseling. Abstinence from cigarette smoking was recorded after six weeks, one year, and two years (see Table 1).
Who’s a candidate?
The patient who expresses the need for help and says he or she truly wants to stop smoking is a candidate for nicotine polacrilex treatment, according to Kevin T. McCusker, MD, assistant professor of internal medicine, division of pulmonary medicine of the University of Utah in Salt Lake City. On the other hand, Dr. McCusker warns, the patient who asks specifically for the gum may not be the best candidate; such a patient may use it superficially, still smoking occasionally without the commitment to quit permanently. Jack Henningrield, PhD, chief, biology of dependence and abuse potential assessment laboratory of the National Institute on Drug Abuse Addiction Research Center, Baltimore, echoes this concern about careful patient selection. Not all heavy smokers are candidates for the use of nicotine polacrilex, he says; as with any cessation program, degree of an individual’s motivation to quit is the major determinant of success. Also, the use of nicotine gum is contraindicated immediately after a myocardial infarction, in pregnant women, and in patients with life-threatening arrhythmias, severe or worsening angina pectoris, or active temporomandibular joint disease.
Drs. McCusker, Henningrield, and David EL. Sachs, MD, director, Smoking Cessation Research Institute, Palo Alto, Calif, offer the following guidelines for successful use of the drug:
* Refer to the drug as nicotine polacrilex or Nicorette rather than as nicotine gum; the latter term evokes images of candy. By using the generic term or trade name, you may more effectively convey the seriousness of its use. Help the patient recognize it as a sustained-release medication.
* Have the patient set a target quit date within one month of deciding to quit.
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Not like bubble gum
According to Dr. Henningfield, laboratory and clinical data indicate that insufficient nicotine dosages and absorption may be the most widespread problems associated with use of nicotine polacrilex. Specific instructions usually help the patient derive maximum benefit from the gum.
*The day before the quit date, instruct the patient on how to chew the nicotine polacrilex, how many pieces to use per day, and what withdrawal symptoms and side effects to watch for.
* Have the patient demonstrate proper chewing technique before leaving the office. This usually involves unlearning habits developed in childhood. First, he should bite into the gum several times but not swallow. Then, he should place the gum between the gingiva and the cheek and wait at least 30 seconds so that the nicotine can be absorbed through the oral mucosa into the bloodstream.
If the patient swallows the nicotine polacrilex with his saliva, most of the drug is destroyed in the stomach before entering the bloodstream. “Used properly, one piece of [2-mg] nicotine polacrilex delivers about 1 mg of nicotine to the bloodstream,” Dr. Henningfield says. In addition to insufficient nicotine absorption, improper chewing may result in side effects such as nausea, headache, hiccups, and gastric disturbances. *Advise the patient that consuming acidic beverages immediately before or while using nicotine polacrilex greatly reduces the absorption of nicotine.
Because of the strong correlation between nicotine dosage and successful smoking cessation, careful attention to the dosage is critical.
* Recommend that during the first two months of treatment the patient use one piece of nicotine polacrilex for every two cigarettes previously smoked. For example, if the patient smoked 30 cigarettes a day, have him substitute 15 pieces of nicotine polacrilex. From this point, you may have to increase or decrease the amount. The average number of pieces per day is 12, but a heavy smoker may use up to 30.
*Initially, prescribe enough nicotine polacrilex to last only 1-2 weeks. If the patient is using the gum properly and does not resume smoking, renew the prescription. If the patient still shows progress after two months, consider writing an open-ended prescription.
*When the patient is comfortable without cigarettes and has had at least one month of tobacco abstinence, slowly taper the dose over the next 2-4 months. For example, a patient chewing a maximum dosage of 14 pieces a day can decrease to 13 during the first week of tapering. If he feels confident enough to cut down faster, instruct him by all means to do so. Warn him to delay the dosage reduction if withdrawal symptoms are noticeable, however.
Follow-up Close initial follow-up is vital.
* Plan to see the patient within 4-7 days of the start of treatment. Be sure he is using the correct chewing technique and using enough to dodges withdrawal symptoms.
* During the time that the patient is using the maximum dosage, see him at intervals of 24 weeks. While the patient is tapering the dosage, see him once a month. Your continued guidance will help the patient stay on the program. Occasional relapses are part of the process of achieving long-term abstinence, and such incidents are opportunities for the physician to encourage, not disparage, the patient.
Dr. McCusker says he has had success in having some patients telephone the office after the initial follow-up, although he admits that A is harder to tell by phone whether a person is adhering to the regimen according to his directions. Dr. Sachs, who is also a clinical assistant professor of respiratory medicine at Stanford University, Stanford, Calif, believes strongly in the importance of close follow-up. He urges physicians who cannot provide it to consider referring the patient to a smoking cessation program that does offer intensive contact with the patient.
Dr. Sachs also warns that “nicotine polacrilex is a substitute source of nicotine and should not be used alternately with cigarettes.” He recommends terminating nicotine polacrilex therapy if you suspect that the patient is continuing to smoke or if the patient has made no progress after approximately 4-6 weeks of treatment.
You can expect sustained abstinence rates of up to 30% in your patients one year after completing treatment. This figure is based on a well-controlled trial in which patients who smoked only one cigarette after treatment with nicotine polacrilex and group therapy were considered failures.* If your patients are very well-motivated, you may expect slightly better success rates.