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Nicotine Reduction Therapy and Relapse Prevention for Heavy Smokers: 3-year Follow-up
S m o k in g C e s s a t io n
Nicotine reduction therapy and relapse prevention for heavy smokers: 3-year follow-up Thomas M . Cooper, D D S Richard R. Clayton, PhD rogress in any scientific field is slow and always inductive. studying two groups of recovering smokers who received 4-mg More often than not, clinical observation and technological nicotine polacrilex and 2-mg nicotine polacrilex respectively, found and pharmaceutical breakthroughs combine, eliciting the that there was a 25% relapse rate for the 4-mg group and a 49.6% researcher’s initial questions and exploratory research. Within a rate for the 2-mg group between the 1- and 2-year followrelapse relatively short period, research studies emerge which require the up periods. The implication is clear; hard-core smokers may need construction of rigorous placebo-controlled and cross-over designs, a higher starting dose of nicotine polacrilex and more pieces per and the exploration of potential confounding variables and day than those who are less nicotine dependent. alternative explanations of results. Eventually, initial questions The 2-mg nicotine polacrilex is clearly superior to the placebo, about the “efficacy” of a treatment model move to another level especially at the 2-year follow-up. Although the data show the of application. importance of using a nicotine replacement therapy, they also In 1969, scientists at the laboratories of A. B. Leo Pharma suggest the significance of exploring psychosocial interventions. ceuticals in Helsingborg, Sweden, developed nicotine polacrilex It should also be noted that, when less dependent subjects taking as a potential pharmaceutical adjunct to behavior modification 2-mg nicotine polacrilex were compared with subjects in the placebo therapy in treating nicotine dependence. For the next several years, group, their 1- to 2-year relapse rates were 26.1% and 58.4%, as the product’s efficacy was tested, appropriate exploratory respectively. questions such as the following were posed and answered: Does Another possible implication of these data concerns the elements nicotine polacrilex produce a significant decrease in withdrawal of intervention that were not discussed by Tonnesen and his symptoms and a corresponding significant increase in long-term colleagues.2 Research by Shiffman3and by Marlatt and Gordon4 success rates, for those who are attempting to quit smoking? emphasizes the importance of incorporating relapse prevention into Subsequent research has provided a generally positive response the treatment of addictive disorders. Reporting on their study, to this question. For example, in a number of rigorously designed Tonnesen and his colleagues2 indicate that all counseling consisting studies, the efficacy of nicotine polacrilex, compared with placebo, of “nonspecific support and encouragement” occurred during the was established for 6-month and 1-year follow-up periods. first 4 months. Perhaps more specific counseling, combined with Differences in magnitude, observed by Jarvis and colleagues' reflect longer treatment, would have maximized relapse prevention and the efficacy of nicotine polacrilex over placebo. One-year chemically increased the overall success rate. verified success rates were 47% for the experimental condition (2 Stated simply, evidence indicates that nicotine polacrilex is mg nicotine polacrilex) and 21% for the placebo group. effective in treating most withdrawal symptoms experienced by Tonnesen and others2 measured nicotine dependence using a quitting smokers. The exploratory question of efficacy is answered. modified version of the Horn-Russell scale. Those who scored in Logically, the next research question is confirmatory. the high-dependence category were randomly assigned to either a 4- or a 2-mg nicotine polacrilex group. Those scoring in the range which indicated less dependence were placed randomly in Table 1 ■ Results from the Tonnesen study.2 either a 2-mg or a placebo group. All subjects participated in six sessions (1 to V/2 hours’ duration) of psychological counseling. Success rate Relapse rate These meetings, involving nonspecific support and encouragement, T reatm ent conditions 1 Year 2 Year Year 1 to Y ear 2 occurred during the first 4 months of treatment. Success rates, Highly dependent assessed at both a 1-year and a 2-year point after entry into 44.4% 4-mg nicotine polacrilex 25.0% 33.3% treatment, were chemically verified (Table 1). 2-mg nicotine polacrilex 6.1% 49.6% 12.1% The findings reported by Tonnesen and his colleagues provide Less dependent strong support for the efficacy of nicotine polacrilex, as well as 2-mg nicotine polacrilex 38.3% 26.1% 28.3% Placebo control 22.6% 9.4% 58.4% clues for other nicotine withdrawal treatment strategies. The delivery of sufficient amounts of medication, for those who have been highly dependent smokers, was important. The researchers,
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S m o k in g C e s s a t io n Effective clinical protocol Information on delivering nicotine replacement therapy to heavy smokers can be extracted from two sources: the extant literature and clinical observations and studies. In the next section, some conclusions drawn from the 1988 Surgeon General’s report is discussed.5 Additionally, an on-going smoking cessation program delivered overthe last4years at the University of Kentucky Hospital and at other area hospitals is described. This group-oriented approach includes the delivery of nicotine polacrilex therapy, behavioral modification techniques, and relapse prevention strategies. The Surgeon General’s report Although the 1988 Surgeon General’s report revealed many significant facts concerning smoking and health, some of its conclusions are especially applicable when nicotine polacrilex is used to treat heavy smokers.5 These findings are summarized in the following five topical statements. Nicotine is addicting. The first and perhaps most salient conclusions of the 1988 Surgeon General’s report are: “a) cigarettes and other forms of tobacco are addicting; b) nicotine is the drug in tobacco that causes addiction, and c) the pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine.”5 A substance must meet specific criteria to be labeled as “addictive.” Henningfield and Jasinski6 describe the abuse and dependence potential criteria that are traditionally considered most important: psychoactive or centrally mediated discriminable effects; mood-elevating or euphoriant effects; reinforcing or rewarding effects; the development of tolerance to the drug; the appearance of withdrawal signs and symptoms associated with abstinence; and high relapse after abstinence. Kozlowski and coworkers7 used selfreport data from samples of persons seeking treatment for alcohol or other drug dependencies to examine the relative dependence across drugs. In general, those dependent on multiple substances reported equal or greater difficulty in quitting than those dependent on single substances. The group with multiple dependencies also reported nearly equal urges to use both cigarettes and other “problem” substances. However, they derived less pleasure from cigarettes than from the other drugs. From a clinical perspective, the most significant criteria that delineate addiction are the fear of withdrawal, the trauma experienced during withdrawal, and the potential for relapse. This is particularly true among heavy smokers, who are painfully aware of their high dependence on nicotine, reluctant to experience the misery of change, and prone to slip back into old and comforting habit patterns. Heavy smokers offer a major challenge. Smoking prevalence has declined from 43% in 1964 (when the first report of the Surgeon General was released) to less than 30% in 1988.8 About one-third of male smokers and one-fifth of female smokers are heavily engaged in the habit. Additionally, although more persons who are black than persons who are white smoke, the latter group smokes more cigarettes per day on average. Those who have a greater dependence on nicotine offer a major challenge to smoking cessation treatment providers. Nicotine replacement therapy is proved clinically successful.
Nicotine polacrilex is the only pharmacological agent approved by the Food and Drug Administration as an adjunct to behavioral modification smoking-cessation treatment. Although this product is consistently effective in decreasing irritability, it is variously effective in reducing other withdrawal symptoms including concentration difficulties, restlessness, hostility, and somatic com plaints.9-13 Henningfield and Jasinski6 indicate that the degree to which withdrawal symptoms are relieved is related to the dose that is actually obtained from nicotine polacrilex. In a review of the efficacy of nicotine polacrilex, Fagerstrom14 reached the following conclusion: “When nicotine gum has been compared with placebo, no-gum control conditions, and other smoking cessation treatments in terms of its effect on outcome, it is clear that nicotine replacement via gum is effective. In long term cessation studies, nicotine gum almost doubles the success rate; at earlier time-points, when nicotine replacement is actually underway, the effect is even more pronounced.” Nicotine polacrilex therapy is more effective when used with behavioral techniques. Studies show that nicotine polacrilex is less effective when it is used singly, and optimally effective when it is used in conjunction with behavioral modification techniques (the product was actually designed as an adjunct to other forms of treatm ent). Hall and associates9 examined three treatm ent conditions: nicotine polacrilex delivery plus an intensive, contactoriented, behavioral treatment program (14 sessions during an 8week period); nicotine polacrilex delivery plus low-contact behavioral treatment (four sessions during a 3-week period); and intensive behavioral treatment alone. The nicotine polacrilex intensive contact condition was significantly superior to the other two interventions at the 6-month, but not the 1-year, follow-up point. In a subsequent study, Hall and associates10 used a 2 * 2 factorial design, which delivered nicotine polacrilex or placebo with intensive behavioral or low contact. Results at 1-year follow-up indicated significant effects only for nicotine polacrilex. Killen and colleagues" found a 50% success rate at 10.5 months for combined behavioral and nicotine polacrilex treatment (versus a 23% success rate for polacrilex treatment alone and a 30% success rate for behavioral treatment alone). However, they did not find these differences to be statistically significant. These mixed results indicate that more effective use of nicotine polacrilex and more robust behavioral treatment regimens are needed. Efforts to deal with these issues will be described later in this paper. Successful drug (nicotine) withdrawal treatment requires a large dose o f relapse prevention. Health care providers must adamantly remind patients not to expect “quick fixes” during recovery from nicotine dependence. An overlearned and functionally positive behavior like cigarette smoking is not relinquished easily. Yet, a considerable number of researchers are testing brief interventions (similar to those that are routinely performed in a medical or dental practice). For example, Hughes and coworkers12 studied 210 smokers assigned to a nicotine polacrilex group and an additional 105 smokers assigned to a placebo group. Both groups attended a family practice clinic, where they received brief advice and smoking cessation literature and viewed smoking cessation slides. Before leaving, they were scheduled for a single follow-up visit. These short interventions were classified as successful when the following conditions were met: the self-reported, sustained 11month quit period was verified by two observers; carbon monoxide levels registered at 10 ppm or less; and cotinine levels were 15
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S m o k in g C e s s a t io n ng/ml or less. Appropriate statistical adjustments were made for marital status and income. The quit-smoking results at 1-year follow up were 10% for the nicotine polacrilex group and 7% for the placebo group. While brief smoking cessation strategies may be classified as “standard” medical treatment, they are not the “preferred” intervention modality for this problem. Shiffman,3 as well as Marlatt and Gordon,4 has stressed the inclusion of more relapse prevention measures in substance abuse treatment. An effective relapse prevention program demands more than brief intervention and brief follow-up. When the problem is drug dependence, the solution should not be restricted to the length of time which health professionals predetermine as expedient and adaptive to daily patient scheduling. Rather, it should be based on the type and degree of treatment which is “needed” to enable each person’s optimal recovery. The results, reported by Hughes and colleagues,12 further reinforce previous conclusions that behavior modification and nicotine replacement therapy become an effective treatment modality when they are used congruently and vigorously. Nicotine reduction therapy and group support offered in a 24-week hospital-based program In March 1984, the 2-mg version of nicotine polacrilex was introduced in the United States. In May 1984, the Kentucky method of smoking cessation (now known as the Cooper/ Clayton method of smoking cessation) was launched; one patient entered treatment. In May 1985, the second patient began an individualized treatment program. On June 19,1985, a group-oriented program was initiated. Since that date, more than 600 patients have entered this smoking cessation program which is delivered in Lexington, Ky, hospital settings, and is available on a fee-for-service basis.13In the following section, the basic elements of the Kentucky method will be described. Three-year follow-up data, collected from observing and testing the first 108 patients who were treated with this method, are reported. Recording consumption: increasing usage awareness This program is designed for heavy smokers (that is, those who smoke 25 or more cigarettes per day). The most frequently mentioned number of cigarettes smoked a day is 30. During the first 2 weeks of the program, each cigarette smoked must be recorded. This process of extended recordkeeping serves three important functions: it allays fear (patients are told during the first meeting that they are expected to continue smoking for 2 additional weeks), it crystallizes personal commitment to quitting, and it increases awareness of highly patterned, individual smoking behaviors. Those in recovery are reminded that cigarettes can accurately be viewed as a drug delivery device. When using cigarettes, smokers are self-administering a drug. Their longestablished pattern of self-administration of nicotine from cigarettes will be used to determine their individualized nicotine polacrilex dosing regimen. Acknowledging dependence Every patient who enters the program must initially complete the Fagerstrom nicotine dependence scale.14 The information compiled from this test enables patients to acknowledge their degree of nicotine dependence, and to increase their general awareness of the dependency (addiction) concept. Most patients who enter smoking cessation programs have tried to quit the habit on 34-S ■ JADA Supplement January 1990
numerous occasions, but have failed. Thus, they become fearful of failing again and tend to attribute their lack of success to internal weaknesses or character flaws. In this program, facilitators counteract the patient’s erroneous perceptions by telling them that their dependency on nicotine is a definite fact. It can be treated, although internal weaknesses and character flaws, which are far more elusive, deep-seated, and ethereal, are relatively untreatable. As they approach the program using this rationale, it is crucial for both facilitators and participants to stress nicotine dependency as the cause of past quitting failures. Group discussions about the relative degrees of nicotine or other drug dependencies help to create a sense of group cohesion and joint problem ownership. Switching to nicotine polacrilex The Cooper/Clayton method is built on the concepts of nicotine replacement and nicotine reduction therapy. The 108 patients who initially participated in this program were apprehensive about quitting smoking. Most had tried to quit previously, had experienced the pain of withdrawal, and had ultimately failed to remain abstinent. Therefore, on the first day of the third week (after 2 weeks of recording nicotine intake via cigarettes), the patients began the process of quitting via nicotine replacement and nicotine reduction therapy (nicotine polacrilex use) (Fig 1). The Federal Drug A dm inistration’s approval of nicotine polacrilex use is contingent on the patient’s complete abstinence from cigarette smoking throughout polacrilex treatment. This plan is currently used by the authors. Results of another study, using the polacrilex and totally stopping cigarette use are reported in January 1989.13 Participants in this study, however, slowly and systematically substituted nicotine formerly received from cigarettes for nicotine from the polacrilex product. Short-term maintenance of nicotine polacrilex dosage Patients who use nicotine polacrilex as a quitting aid must maintain this product as their only source of nicotine. Under ideal conditions, smokers transfer from their original source of nicotine to nicotine polacrilex immediately. However, heavy smokers who have a high fear of failure and a more serious nicotine dependence, may take 2 weeks or longer. In our program, after patients have used the polacrilex product as the only nicotine source for 2 weeks, they are instructed (for the following 2-week period) to reduce nicotine polacrilex to one piece per hour. They continue on this all-day schedule for the next 2 weeks. By this time, patients have abstained from cigarette smoking for a total of 6 weeks: (2 initial weeks when alternate source usage was maximum; 2 additional weeks when nicotine polacrilex use was being reduced; and 2 more weeks when maintenance was sustained, at approximately one nicotine polacrilex piece per hour). Eliminating the use of nicotine polacrilex The ultimate goal of this program is to totally eliminte nicotine use; quitting smoking is only part of this process. During week 9 in the program (6 weeks into cigarette abstinence), the patients eliminate the first daily piece of nicotine polacrilex, but systematically take the rest. The following week (week 10), the first and second daily pieces are eliminated, but the remaining pieces are taken. In 16 weeks, the use of nicotine polacrilex is slowly and methodically eliminated. Many health care providers have been concerned about the potential for dependence on nicotine polacrilex because of the
S m o k in g C e s s a t io n to slips and relapse, are framed positively; negative thinking is discouraged. During the meetings, attention is focused on relapse prevention. This includes identifying and avoiding situations with a high potential for relapse, developing skills for resisting periods of craving, effective techniques for using nicotine polacrilex, dealing with the potential for weight gain, engaging in effective exercise programs, coping with depression and bereavement over cigarette loss, and other methods. The 24-week treatment period allows ample time for natural, nonmanipulative, and repeated discussions of these issues (an effective reinforcement strategy).
NICOTINE REDUCTION THERAPY
Results from a 3-year clinical follow-up
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Fig 1 ■ The 24-week smoking cessation program consisted o f three stages o f nicotine reduction. The 2-week baseline period determined cigarette smoking patterns. During weeks 3 through 8, the patient substituted nicotine polacrilex for cigarettes, achieved comfort at a level below the previous cigarette nicotine level, then reduced nicotine intake over a 6-week period. Weeks 9 through 16 were used to eliminate the patient’s use o f nicotine by slowly reducing nicotine intake to zero.
present lack of available strategies which systematically reduce and finally eliminate its use. The process described here can be used to alleviate some of these concerns, even though there is no present, specific evidence to support the claim that persons can become dependent on nicotine via nicotine polacrilex. All patients who use this product therapeutically are already dependent on nicotine. Those who deliver this therapy merely switch the administration route and the drug source. Support groups designed to assist in behavior modification and relapse prevention Support groups, consisting of five to 20 people, meet once each week in a hospital classroom. Entrance into the program is based on a “rolling admissions” process. Groups operate 52 weeks per year. Each patient joins when ready, attends a group meeting once per week, for 24 consecutive weeks. This time period may be extended to 30 weeks for patients who have a great deal of difficulty quitting. Most heavy smokers understand the logic and need for a longer-term treatment process and are willing to remain in treatment for this predetermined time span. One of the strongest features of the rolling admissions process is continuity of care. Another is the principle of the student (patient) becoming the teacher (taken from adolescent and adult drug treatment programs). Those who are more advanced in the program held those who are newer. The more experienced group members help beginners to solve problems concerning use of nicotine polacrilex, to avoid situations which present smoking temptations, and to learn to feel positive about their new lifestyle. From a practice management perspective, these strategies enable the program to maintain momentum. The group sessions, conducted very informally, usually involve brief exchanges of relevant information on individual reasons for smoking or using drugs, dependency issues, and tips on use of nicotine polacrilex. An open discussion follows, with each patient sharing individual problems or progress encountered during the previous week. The group becomes spontaneously involved in helping specific persons who are experiencing difficulties. The group leader provides insights gleaned from prior clinical experiences. Progress for each patient (not immediate and total success) is the central theme of each meeting. All problems, including those related
The following investigation was not designed as a rigorous experimental study with random assignment and placebo controls (the kind which is invaluable for understanding efficacy). Instead, this study followed 108 nonselected patients who participated in a clinical smoking cessation program conducted by a dentist and a sociologist in a local hospital. The sample consisted of 28 males and 80 females who enrolled in the program for several months (during 1985 and 1986), and who, at the most recent follow-up visit (March 1, 1989), have not smoked for an average of 36.1 months. Among the 28 males who entered the program, 12 (42.8%) who were not smoking at the 1-year follow-up were reinterviewed at the 3-year point. Of those, the eight people who reported abstinence at year 3 were chemically verified with a carbon dioxide meter, with 8 ppm or less as the criterion. The average age of these eight males was 43.9 years. They had smoked an average of 29.8 cigarettes per day when they entered the program and had been off cigarettes an average of 39.8 months. Sixteen males were unsuccessful in quitting at the end of 1 year. One member moved during treatment, and 11 participants attended five or fewer of the group sessions. Therefore, three-fourths of the unsuccessful males were not fully exposed to treatment. Of the 80 females who entered the program, 37 were chemically verified as nonsmokers at 1 year. Of the 43 who were unsuccessful at 1 year, several had attended five or fewer meetings and one moved before receiving substantial exposure to treatment. At the 3-year point, 31 of the 80 (38.5%) were chemically verified as nonsmokers. The mean age of this group was 49.8 years. They had previously smoked approximately 34.8 cigarettes per day and had not smoked for an average of 35 months. Forty-nine of the 108 patients (45.3%) who entered the program were not smoking at the end of 1 year. Between the first and the 3-year follow-up, ten of these patients relapsed, leaving a 3-year success rate of 36% (39 of 108). Stated differently, 79.5% of those who were not smoking at 1 year were still not smoking at the 3-year point. This is a ringing endorsement for relapse prevention programs. Even more significantly, three of the patients who were smoking at year 1 were nonsmokers at year 3. Therefore, at the 3-year follow-up, 42 of the original 108 patients (38.5%) were nonsmokers. D iscussion
Facilitators who are assisting heavy smokers to quit smoking must know each person’s former pattern of nicotine self-administration via cigarettes. Professionals who treat patients with nicotine polacrilex (as an alternate, less damaging source of nicotine) must consider the patient’s perceived need for nicotine before prescribing specific dosage levels. The terms “nicotine replacement therapy” and “nicotine reduction therapy” are important concepts, used to
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S m o k in g C e s s a t io n achieve the smoking cessation goal.15 By removing the rapid absorption of nicotine, formerly derived from cigarette smoking, nicotine polacrilex administration (a replacement therapy) severs old reinforcement patterns. As a treatment modality specifically designed to immediately eliminate cigarette use and gradually eliminate nicotine ingestion, nicotine reduction therapy is highly appropriate. The regularity of nicotine polacrilex use is important because of the relatively long time involved (about 10 minutes) for its absorption through the buccal mucosa to the brain. To achieve maximum results, it is crucial to take this medication “by the clock.” Patient instructions for use (approved by the FDA in 1983) suggest an ad lib dosing schedule. This has been interpreted as “use it when you crave nicotine.” However, because patients absorb the nicotine in polacrilex in 10 minutes (instead of absorbing the nicotine in smoke in 7 seconds), they must take the polacrilex product regularly. If they wait until it is craved, they are asking for failure. Because we know of no other prescribed medication that is directed to be taken “at will,” we choose to use the term “as needed.” The recorded pattern of nicotine self-administration via cigarettes is clearly the most accurate guide to nicotine polacrilex dosage amount and regularity. It is essential to understand the delivery process of nicotine polacrilex use. Buccal absorption of nicotine is pH-dependent. The pH must be 7.4 or higher for significant amounts of nicotine to pass through the buccal mucosa. Any acidic beverage (coffee, tea, soft drinks, or beer) will interfere with a most important process— getting nicotine to the brain on a patterned and sustained basis. It is recommended that patients who wish to drink a beverage remove the nicotine polacrilex, have their drink, rinse their mouths with water (to neutralize the pH to 7.0), and reinsert the medication. Also, the product should be held in the same general oral area to make the buffering agent (sodium bicarbonate) site-specific. Finally, it is suggested that vigorous chewing should be avoided, because it releases excessive amounts of nicotine, sodium bicarbonate, and saliva, which all wash into the stomach. Benowitz15 has shown that only 2% of the nicotine washed into the stomach reaches the blood, compared with approximately 86% of nicotine which is absorbed through the buccal mucosa. If patients understand the role of oral pH, they are more apt to use nicotine polacrilex effectively. The concept of nicotine replacement implies the matching of nicotine dosages. It is important to note that this program offers a nicotine reduction plan, not a permanent nicotine replacement plan. From the first 2 weeks of treatment, the only source of nicotine is nicotine polacrilex. Thus, there is at least an immediate 20% reduction in total daily nicotine consumption. In addition, the nicotine absorbed from the polacrilex takes a longer time to reach the brain. These factors contribute to an overall reduction in nicotine’s reinforcing effects. Also, nicotine polacrilex is a cleaner source of the drug. From the outset, our program involves a consistent, gradual reduction in nicotine consumption. The administration of nicotine reduction therapy combined with extensive behavioral modification appears to be the most effective treatment available for heavy smokers. The 1-year success rate of 45.3% observed with 108 patients, supports the original hypothesis that nicotine replacement therapy is an appropriate treatment regimen for heavy smokers. The 3-year point prevalence rate (36% cessation) supports the hypothesis that nicotine reduction therapy, delivered in a gradual, systematic manner and coupled with support group and relapsed prevention, can increase long-term smoking cessation rates, even in heavy smokers. 36-S ■ JADA Supplement January 1990
Conclusions
People learn cigarette smoking behavior over time. They can also slowly and methodically unlearn smoking behavior as they gradually weaken the series of strong associations formerly linked to smoking. Thus, behavioral modification is essential in any smoking cessation program aiming to achieve long-term success. Nicotine polacrilex treatment, which replaces the nicotine formerly provided by cigarettes, is a viable adjunct when used concurrently with behavioral modification. It is important to prescribe nicotine polacrilex in dosages similar to those received from cigarettes to avoid smoking relapse. A slow and methodical reduction of nicotine polacrilex may serve as a retraining process, conditioning the brain receptor sites to accept consecutively smaller amounts of nicotine as “normal” doses, until zero nicotine intake is once again perceived as “normal.” The fact that 79.5% of heavy smokers seen at year 1 were still nonsmokers at year 3 suggests that nicotine reduction therapy (via 2-mg nicotine polacrilex administration), combined with long-term behavioral modification, provides effective smoking cessation treatment. D r. C ooper is professor, departm ent of oral health sciences, College of Dentistry at the University of Kentucky; and D r. Clayton is professor, departm ent of sociology and scientific director of the Center for Prevention Research, the University of Kentucky, Lexington. Address requests for reprints to Dr. Cooper at M-129, C handler M edical Center, Lexington, KY 40536. 1. Jarvis MS, Raw M , Russell M AH. Random ized controlled trial of nicotine chewing gum. Br J Med 1982;285:537-40. 2. Tonnesen P, Fryd V, Hansen M. Effect of nicotine chewing gum in com bination with group counseling on the cessation of smoking. N Engl J Med 1988;318:15-8. 3. Shiffman S. Relapse following sm oking cessation: a situational analysis. J Consult Clin Psychol 1982;50:71-86. 4. M arlatt GA, Gordon JR , eds. Relapse prevention: maintenance strategies in the treatm ent of addictive behavior. New York: Guilford, 1985. 5. US D ep artm en t of H ealth and H um an Services. The health consequences of smoking. Nicotine addiction. A report of the Surgeon General. W ashington, DC: US Governm ent Printing Office, 1988; D H HS publication no. (CDC) 88-8406. 6. Henningfield JE , Jasinski DR. Pharm acologic basis for nicotine replacement. In: Pom erleau O F, Pom erleau CS, eds. Nicotine replacement: a critical evaluation. New York: Alan R. Liss, 1988:35-61. 7. Kozlowski LT, W ilkinson A, Skinner W, Kent C, Franklin T, Pope M. Com paring tobacco cigarette dependence with other drug dependencies. JA M A 1989;261:898-901. 8. W arner KE. Effects of the antism oking campaign: an update. Am J Public Health 1989;79:144-51. 9. Hall SM , Tunstall C, Rugg D. Nicotine gum and behavioral treatm ent in sm oking cessation. J Consult Clin Psychol 1985;53:256-8. 10. Hall SM , Tunstall C, Benowitz NL, Jones RT. Nicotine gum and behavioral treatm ent: a placebo controlled trial. J Consult Clin Psychol 1987;55:603-5. 11. Killen JD , Maccoby N, Taylor CB. Nicotine gum and self-regulation training in smoking relapse prevention. Behav Ther 1984;15:234-48. 12. Hughes JR , Gust SW, Keenan RM . Nicotine vs. placebo gum in general medical practice. JA M A 1989;261:1300-6. 13. C ooper TM, Clayton RR. Stop-sm oking program using nicotine reduction therapy and behavior m odification for heavy smokers. JA D A 1989;118:47-51. 14. Fagerstrom KO. A comparison of psychological and pharmacological treatm ent in smoking cessation. J Behav Med 1982;5:348-51. 15. Benowitz NL. Toxicity of nicotine: implications with regard to nico tine replacement therapy. In: Pom erleau O F, Pom erleau CS, eds. Nicotine replacement: a critical evaluation. New York: Alan R. Liss, 1988:187-217.
Nicotine reduction therapy and relapse prevention for heavy smokers: 3-year follow-up Thomas M . Cooper, D D S Richard R. Clayton, PhD rogress in any scientific field is slow and always inductive. studying two groups of recovering smokers who received 4-mg More often than not, clinical observation and technological nicotine polacrilex and 2-mg nicotine polacrilex respectively, found and pharmaceutical breakthroughs combine, eliciting the that there was a 25% relapse rate for the 4-mg group and a 49.6% researcher’s initial questions and exploratory research. Within a rate for the 2-mg group between the 1- and 2-year followrelapse relatively short period, research studies emerge which require the up periods. The implication is clear; hard-core smokers may need construction of rigorous placebo-controlled and cross-over designs, a higher starting dose of nicotine polacrilex and more pieces per and the exploration of potential confounding variables and day than those who are less nicotine dependent. alternative explanations of results. Eventually, initial questions The 2-mg nicotine polacrilex is clearly superior to the placebo, about the “efficacy” of a treatment model move to another level especially at the 2-year follow-up. Although the data show the of application. importance of using a nicotine replacement therapy, they also In 1969, scientists at the laboratories of A. B. Leo Pharma suggest the significance of exploring psychosocial interventions. ceuticals in Helsingborg, Sweden, developed nicotine polacrilex It should also be noted that, when less dependent subjects taking as a potential pharmaceutical adjunct to behavior modification 2-mg nicotine polacrilex were compared with subjects in the placebo therapy in treating nicotine dependence. For the next several years, group, their 1- to 2-year relapse rates were 26.1% and 58.4%, as the product’s efficacy was tested, appropriate exploratory respectively. questions such as the following were posed and answered: Does Another possible implication of these data concerns the elements nicotine polacrilex produce a significant decrease in withdrawal of intervention that were not discussed by Tonnesen and his symptoms and a corresponding significant increase in long-term colleagues.2 Research by Shiffman3and by Marlatt and Gordon4 success rates, for those who are attempting to quit smoking? emphasizes the importance of incorporating relapse prevention into Subsequent research has provided a generally positive response the treatment of addictive disorders. Reporting on their study, to this question. For example, in a number of rigorously designed Tonnesen and his colleagues2 indicate that all counseling consisting studies, the efficacy of nicotine polacrilex, compared with placebo, of “nonspecific support and encouragement” occurred during the was established for 6-month and 1-year follow-up periods. first 4 months. Perhaps more specific counseling, combined with Differences in magnitude, observed by Jarvis and colleagues' reflect longer treatment, would have maximized relapse prevention and the efficacy of nicotine polacrilex over placebo. One-year chemically increased the overall success rate. verified success rates were 47% for the experimental condition (2 Stated simply, evidence indicates that nicotine polacrilex is mg nicotine polacrilex) and 21% for the placebo group. effective in treating most withdrawal symptoms experienced by Tonnesen and others2 measured nicotine dependence using a quitting smokers. The exploratory question of efficacy is answered. modified version of the Horn-Russell scale. Those who scored in Logically, the next research question is confirmatory. the high-dependence category were randomly assigned to either a 4- or a 2-mg nicotine polacrilex group. Those scoring in the range which indicated less dependence were placed randomly in Table 1 ■ Results from the Tonnesen study.2 either a 2-mg or a placebo group. All subjects participated in six sessions (1 to V/2 hours’ duration) of psychological counseling. Success rate Relapse rate These meetings, involving nonspecific support and encouragement, T reatm ent conditions 1 Year 2 Year Year 1 to Y ear 2 occurred during the first 4 months of treatment. Success rates, Highly dependent assessed at both a 1-year and a 2-year point after entry into 44.4% 4-mg nicotine polacrilex 25.0% 33.3% treatment, were chemically verified (Table 1). 2-mg nicotine polacrilex 6.1% 49.6% 12.1% The findings reported by Tonnesen and his colleagues provide Less dependent strong support for the efficacy of nicotine polacrilex, as well as 2-mg nicotine polacrilex 38.3% 26.1% 28.3% Placebo control 22.6% 9.4% 58.4% clues for other nicotine withdrawal treatment strategies. The delivery of sufficient amounts of medication, for those who have been highly dependent smokers, was important. The researchers,
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S m o k in g C e s s a t io n Effective clinical protocol Information on delivering nicotine replacement therapy to heavy smokers can be extracted from two sources: the extant literature and clinical observations and studies. In the next section, some conclusions drawn from the 1988 Surgeon General’s report is discussed.5 Additionally, an on-going smoking cessation program delivered overthe last4years at the University of Kentucky Hospital and at other area hospitals is described. This group-oriented approach includes the delivery of nicotine polacrilex therapy, behavioral modification techniques, and relapse prevention strategies. The Surgeon General’s report Although the 1988 Surgeon General’s report revealed many significant facts concerning smoking and health, some of its conclusions are especially applicable when nicotine polacrilex is used to treat heavy smokers.5 These findings are summarized in the following five topical statements. Nicotine is addicting. The first and perhaps most salient conclusions of the 1988 Surgeon General’s report are: “a) cigarettes and other forms of tobacco are addicting; b) nicotine is the drug in tobacco that causes addiction, and c) the pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine.”5 A substance must meet specific criteria to be labeled as “addictive.” Henningfield and Jasinski6 describe the abuse and dependence potential criteria that are traditionally considered most important: psychoactive or centrally mediated discriminable effects; mood-elevating or euphoriant effects; reinforcing or rewarding effects; the development of tolerance to the drug; the appearance of withdrawal signs and symptoms associated with abstinence; and high relapse after abstinence. Kozlowski and coworkers7 used selfreport data from samples of persons seeking treatment for alcohol or other drug dependencies to examine the relative dependence across drugs. In general, those dependent on multiple substances reported equal or greater difficulty in quitting than those dependent on single substances. The group with multiple dependencies also reported nearly equal urges to use both cigarettes and other “problem” substances. However, they derived less pleasure from cigarettes than from the other drugs. From a clinical perspective, the most significant criteria that delineate addiction are the fear of withdrawal, the trauma experienced during withdrawal, and the potential for relapse. This is particularly true among heavy smokers, who are painfully aware of their high dependence on nicotine, reluctant to experience the misery of change, and prone to slip back into old and comforting habit patterns. Heavy smokers offer a major challenge. Smoking prevalence has declined from 43% in 1964 (when the first report of the Surgeon General was released) to less than 30% in 1988.8 About one-third of male smokers and one-fifth of female smokers are heavily engaged in the habit. Additionally, although more persons who are black than persons who are white smoke, the latter group smokes more cigarettes per day on average. Those who have a greater dependence on nicotine offer a major challenge to smoking cessation treatment providers. Nicotine replacement therapy is proved clinically successful.
Nicotine polacrilex is the only pharmacological agent approved by the Food and Drug Administration as an adjunct to behavioral modification smoking-cessation treatment. Although this product is consistently effective in decreasing irritability, it is variously effective in reducing other withdrawal symptoms including concentration difficulties, restlessness, hostility, and somatic com plaints.9-13 Henningfield and Jasinski6 indicate that the degree to which withdrawal symptoms are relieved is related to the dose that is actually obtained from nicotine polacrilex. In a review of the efficacy of nicotine polacrilex, Fagerstrom14 reached the following conclusion: “When nicotine gum has been compared with placebo, no-gum control conditions, and other smoking cessation treatments in terms of its effect on outcome, it is clear that nicotine replacement via gum is effective. In long term cessation studies, nicotine gum almost doubles the success rate; at earlier time-points, when nicotine replacement is actually underway, the effect is even more pronounced.” Nicotine polacrilex therapy is more effective when used with behavioral techniques. Studies show that nicotine polacrilex is less effective when it is used singly, and optimally effective when it is used in conjunction with behavioral modification techniques (the product was actually designed as an adjunct to other forms of treatm ent). Hall and associates9 examined three treatm ent conditions: nicotine polacrilex delivery plus an intensive, contactoriented, behavioral treatment program (14 sessions during an 8week period); nicotine polacrilex delivery plus low-contact behavioral treatment (four sessions during a 3-week period); and intensive behavioral treatment alone. The nicotine polacrilex intensive contact condition was significantly superior to the other two interventions at the 6-month, but not the 1-year, follow-up point. In a subsequent study, Hall and associates10 used a 2 * 2 factorial design, which delivered nicotine polacrilex or placebo with intensive behavioral or low contact. Results at 1-year follow-up indicated significant effects only for nicotine polacrilex. Killen and colleagues" found a 50% success rate at 10.5 months for combined behavioral and nicotine polacrilex treatment (versus a 23% success rate for polacrilex treatment alone and a 30% success rate for behavioral treatment alone). However, they did not find these differences to be statistically significant. These mixed results indicate that more effective use of nicotine polacrilex and more robust behavioral treatment regimens are needed. Efforts to deal with these issues will be described later in this paper. Successful drug (nicotine) withdrawal treatment requires a large dose o f relapse prevention. Health care providers must adamantly remind patients not to expect “quick fixes” during recovery from nicotine dependence. An overlearned and functionally positive behavior like cigarette smoking is not relinquished easily. Yet, a considerable number of researchers are testing brief interventions (similar to those that are routinely performed in a medical or dental practice). For example, Hughes and coworkers12 studied 210 smokers assigned to a nicotine polacrilex group and an additional 105 smokers assigned to a placebo group. Both groups attended a family practice clinic, where they received brief advice and smoking cessation literature and viewed smoking cessation slides. Before leaving, they were scheduled for a single follow-up visit. These short interventions were classified as successful when the following conditions were met: the self-reported, sustained 11month quit period was verified by two observers; carbon monoxide levels registered at 10 ppm or less; and cotinine levels were 15
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S m o k in g C e s s a t io n ng/ml or less. Appropriate statistical adjustments were made for marital status and income. The quit-smoking results at 1-year follow up were 10% for the nicotine polacrilex group and 7% for the placebo group. While brief smoking cessation strategies may be classified as “standard” medical treatment, they are not the “preferred” intervention modality for this problem. Shiffman,3 as well as Marlatt and Gordon,4 has stressed the inclusion of more relapse prevention measures in substance abuse treatment. An effective relapse prevention program demands more than brief intervention and brief follow-up. When the problem is drug dependence, the solution should not be restricted to the length of time which health professionals predetermine as expedient and adaptive to daily patient scheduling. Rather, it should be based on the type and degree of treatment which is “needed” to enable each person’s optimal recovery. The results, reported by Hughes and colleagues,12 further reinforce previous conclusions that behavior modification and nicotine replacement therapy become an effective treatment modality when they are used congruently and vigorously. Nicotine reduction therapy and group support offered in a 24-week hospital-based program In March 1984, the 2-mg version of nicotine polacrilex was introduced in the United States. In May 1984, the Kentucky method of smoking cessation (now known as the Cooper/ Clayton method of smoking cessation) was launched; one patient entered treatment. In May 1985, the second patient began an individualized treatment program. On June 19,1985, a group-oriented program was initiated. Since that date, more than 600 patients have entered this smoking cessation program which is delivered in Lexington, Ky, hospital settings, and is available on a fee-for-service basis.13In the following section, the basic elements of the Kentucky method will be described. Three-year follow-up data, collected from observing and testing the first 108 patients who were treated with this method, are reported. Recording consumption: increasing usage awareness This program is designed for heavy smokers (that is, those who smoke 25 or more cigarettes per day). The most frequently mentioned number of cigarettes smoked a day is 30. During the first 2 weeks of the program, each cigarette smoked must be recorded. This process of extended recordkeeping serves three important functions: it allays fear (patients are told during the first meeting that they are expected to continue smoking for 2 additional weeks), it crystallizes personal commitment to quitting, and it increases awareness of highly patterned, individual smoking behaviors. Those in recovery are reminded that cigarettes can accurately be viewed as a drug delivery device. When using cigarettes, smokers are self-administering a drug. Their longestablished pattern of self-administration of nicotine from cigarettes will be used to determine their individualized nicotine polacrilex dosing regimen. Acknowledging dependence Every patient who enters the program must initially complete the Fagerstrom nicotine dependence scale.14 The information compiled from this test enables patients to acknowledge their degree of nicotine dependence, and to increase their general awareness of the dependency (addiction) concept. Most patients who enter smoking cessation programs have tried to quit the habit on 34-S ■ JADA Supplement January 1990
numerous occasions, but have failed. Thus, they become fearful of failing again and tend to attribute their lack of success to internal weaknesses or character flaws. In this program, facilitators counteract the patient’s erroneous perceptions by telling them that their dependency on nicotine is a definite fact. It can be treated, although internal weaknesses and character flaws, which are far more elusive, deep-seated, and ethereal, are relatively untreatable. As they approach the program using this rationale, it is crucial for both facilitators and participants to stress nicotine dependency as the cause of past quitting failures. Group discussions about the relative degrees of nicotine or other drug dependencies help to create a sense of group cohesion and joint problem ownership. Switching to nicotine polacrilex The Cooper/Clayton method is built on the concepts of nicotine replacement and nicotine reduction therapy. The 108 patients who initially participated in this program were apprehensive about quitting smoking. Most had tried to quit previously, had experienced the pain of withdrawal, and had ultimately failed to remain abstinent. Therefore, on the first day of the third week (after 2 weeks of recording nicotine intake via cigarettes), the patients began the process of quitting via nicotine replacement and nicotine reduction therapy (nicotine polacrilex use) (Fig 1). The Federal Drug A dm inistration’s approval of nicotine polacrilex use is contingent on the patient’s complete abstinence from cigarette smoking throughout polacrilex treatment. This plan is currently used by the authors. Results of another study, using the polacrilex and totally stopping cigarette use are reported in January 1989.13 Participants in this study, however, slowly and systematically substituted nicotine formerly received from cigarettes for nicotine from the polacrilex product. Short-term maintenance of nicotine polacrilex dosage Patients who use nicotine polacrilex as a quitting aid must maintain this product as their only source of nicotine. Under ideal conditions, smokers transfer from their original source of nicotine to nicotine polacrilex immediately. However, heavy smokers who have a high fear of failure and a more serious nicotine dependence, may take 2 weeks or longer. In our program, after patients have used the polacrilex product as the only nicotine source for 2 weeks, they are instructed (for the following 2-week period) to reduce nicotine polacrilex to one piece per hour. They continue on this all-day schedule for the next 2 weeks. By this time, patients have abstained from cigarette smoking for a total of 6 weeks: (2 initial weeks when alternate source usage was maximum; 2 additional weeks when nicotine polacrilex use was being reduced; and 2 more weeks when maintenance was sustained, at approximately one nicotine polacrilex piece per hour). Eliminating the use of nicotine polacrilex The ultimate goal of this program is to totally eliminte nicotine use; quitting smoking is only part of this process. During week 9 in the program (6 weeks into cigarette abstinence), the patients eliminate the first daily piece of nicotine polacrilex, but systematically take the rest. The following week (week 10), the first and second daily pieces are eliminated, but the remaining pieces are taken. In 16 weeks, the use of nicotine polacrilex is slowly and methodically eliminated. Many health care providers have been concerned about the potential for dependence on nicotine polacrilex because of the
S m o k in g C e s s a t io n to slips and relapse, are framed positively; negative thinking is discouraged. During the meetings, attention is focused on relapse prevention. This includes identifying and avoiding situations with a high potential for relapse, developing skills for resisting periods of craving, effective techniques for using nicotine polacrilex, dealing with the potential for weight gain, engaging in effective exercise programs, coping with depression and bereavement over cigarette loss, and other methods. The 24-week treatment period allows ample time for natural, nonmanipulative, and repeated discussions of these issues (an effective reinforcement strategy).
NICOTINE REDUCTION THERAPY
Results from a 3-year clinical follow-up
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Fig 1 ■ The 24-week smoking cessation program consisted o f three stages o f nicotine reduction. The 2-week baseline period determined cigarette smoking patterns. During weeks 3 through 8, the patient substituted nicotine polacrilex for cigarettes, achieved comfort at a level below the previous cigarette nicotine level, then reduced nicotine intake over a 6-week period. Weeks 9 through 16 were used to eliminate the patient’s use o f nicotine by slowly reducing nicotine intake to zero.
present lack of available strategies which systematically reduce and finally eliminate its use. The process described here can be used to alleviate some of these concerns, even though there is no present, specific evidence to support the claim that persons can become dependent on nicotine via nicotine polacrilex. All patients who use this product therapeutically are already dependent on nicotine. Those who deliver this therapy merely switch the administration route and the drug source. Support groups designed to assist in behavior modification and relapse prevention Support groups, consisting of five to 20 people, meet once each week in a hospital classroom. Entrance into the program is based on a “rolling admissions” process. Groups operate 52 weeks per year. Each patient joins when ready, attends a group meeting once per week, for 24 consecutive weeks. This time period may be extended to 30 weeks for patients who have a great deal of difficulty quitting. Most heavy smokers understand the logic and need for a longer-term treatment process and are willing to remain in treatment for this predetermined time span. One of the strongest features of the rolling admissions process is continuity of care. Another is the principle of the student (patient) becoming the teacher (taken from adolescent and adult drug treatment programs). Those who are more advanced in the program held those who are newer. The more experienced group members help beginners to solve problems concerning use of nicotine polacrilex, to avoid situations which present smoking temptations, and to learn to feel positive about their new lifestyle. From a practice management perspective, these strategies enable the program to maintain momentum. The group sessions, conducted very informally, usually involve brief exchanges of relevant information on individual reasons for smoking or using drugs, dependency issues, and tips on use of nicotine polacrilex. An open discussion follows, with each patient sharing individual problems or progress encountered during the previous week. The group becomes spontaneously involved in helping specific persons who are experiencing difficulties. The group leader provides insights gleaned from prior clinical experiences. Progress for each patient (not immediate and total success) is the central theme of each meeting. All problems, including those related
The following investigation was not designed as a rigorous experimental study with random assignment and placebo controls (the kind which is invaluable for understanding efficacy). Instead, this study followed 108 nonselected patients who participated in a clinical smoking cessation program conducted by a dentist and a sociologist in a local hospital. The sample consisted of 28 males and 80 females who enrolled in the program for several months (during 1985 and 1986), and who, at the most recent follow-up visit (March 1, 1989), have not smoked for an average of 36.1 months. Among the 28 males who entered the program, 12 (42.8%) who were not smoking at the 1-year follow-up were reinterviewed at the 3-year point. Of those, the eight people who reported abstinence at year 3 were chemically verified with a carbon dioxide meter, with 8 ppm or less as the criterion. The average age of these eight males was 43.9 years. They had smoked an average of 29.8 cigarettes per day when they entered the program and had been off cigarettes an average of 39.8 months. Sixteen males were unsuccessful in quitting at the end of 1 year. One member moved during treatment, and 11 participants attended five or fewer of the group sessions. Therefore, three-fourths of the unsuccessful males were not fully exposed to treatment. Of the 80 females who entered the program, 37 were chemically verified as nonsmokers at 1 year. Of the 43 who were unsuccessful at 1 year, several had attended five or fewer meetings and one moved before receiving substantial exposure to treatment. At the 3-year point, 31 of the 80 (38.5%) were chemically verified as nonsmokers. The mean age of this group was 49.8 years. They had previously smoked approximately 34.8 cigarettes per day and had not smoked for an average of 35 months. Forty-nine of the 108 patients (45.3%) who entered the program were not smoking at the end of 1 year. Between the first and the 3-year follow-up, ten of these patients relapsed, leaving a 3-year success rate of 36% (39 of 108). Stated differently, 79.5% of those who were not smoking at 1 year were still not smoking at the 3-year point. This is a ringing endorsement for relapse prevention programs. Even more significantly, three of the patients who were smoking at year 1 were nonsmokers at year 3. Therefore, at the 3-year follow-up, 42 of the original 108 patients (38.5%) were nonsmokers. D iscussion
Facilitators who are assisting heavy smokers to quit smoking must know each person’s former pattern of nicotine self-administration via cigarettes. Professionals who treat patients with nicotine polacrilex (as an alternate, less damaging source of nicotine) must consider the patient’s perceived need for nicotine before prescribing specific dosage levels. The terms “nicotine replacement therapy” and “nicotine reduction therapy” are important concepts, used to
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S m o k in g C e s s a t io n achieve the smoking cessation goal.15 By removing the rapid absorption of nicotine, formerly derived from cigarette smoking, nicotine polacrilex administration (a replacement therapy) severs old reinforcement patterns. As a treatment modality specifically designed to immediately eliminate cigarette use and gradually eliminate nicotine ingestion, nicotine reduction therapy is highly appropriate. The regularity of nicotine polacrilex use is important because of the relatively long time involved (about 10 minutes) for its absorption through the buccal mucosa to the brain. To achieve maximum results, it is crucial to take this medication “by the clock.” Patient instructions for use (approved by the FDA in 1983) suggest an ad lib dosing schedule. This has been interpreted as “use it when you crave nicotine.” However, because patients absorb the nicotine in polacrilex in 10 minutes (instead of absorbing the nicotine in smoke in 7 seconds), they must take the polacrilex product regularly. If they wait until it is craved, they are asking for failure. Because we know of no other prescribed medication that is directed to be taken “at will,” we choose to use the term “as needed.” The recorded pattern of nicotine self-administration via cigarettes is clearly the most accurate guide to nicotine polacrilex dosage amount and regularity. It is essential to understand the delivery process of nicotine polacrilex use. Buccal absorption of nicotine is pH-dependent. The pH must be 7.4 or higher for significant amounts of nicotine to pass through the buccal mucosa. Any acidic beverage (coffee, tea, soft drinks, or beer) will interfere with a most important process— getting nicotine to the brain on a patterned and sustained basis. It is recommended that patients who wish to drink a beverage remove the nicotine polacrilex, have their drink, rinse their mouths with water (to neutralize the pH to 7.0), and reinsert the medication. Also, the product should be held in the same general oral area to make the buffering agent (sodium bicarbonate) site-specific. Finally, it is suggested that vigorous chewing should be avoided, because it releases excessive amounts of nicotine, sodium bicarbonate, and saliva, which all wash into the stomach. Benowitz15 has shown that only 2% of the nicotine washed into the stomach reaches the blood, compared with approximately 86% of nicotine which is absorbed through the buccal mucosa. If patients understand the role of oral pH, they are more apt to use nicotine polacrilex effectively. The concept of nicotine replacement implies the matching of nicotine dosages. It is important to note that this program offers a nicotine reduction plan, not a permanent nicotine replacement plan. From the first 2 weeks of treatment, the only source of nicotine is nicotine polacrilex. Thus, there is at least an immediate 20% reduction in total daily nicotine consumption. In addition, the nicotine absorbed from the polacrilex takes a longer time to reach the brain. These factors contribute to an overall reduction in nicotine’s reinforcing effects. Also, nicotine polacrilex is a cleaner source of the drug. From the outset, our program involves a consistent, gradual reduction in nicotine consumption. The administration of nicotine reduction therapy combined with extensive behavioral modification appears to be the most effective treatment available for heavy smokers. The 1-year success rate of 45.3% observed with 108 patients, supports the original hypothesis that nicotine replacement therapy is an appropriate treatment regimen for heavy smokers. The 3-year point prevalence rate (36% cessation) supports the hypothesis that nicotine reduction therapy, delivered in a gradual, systematic manner and coupled with support group and relapsed prevention, can increase long-term smoking cessation rates, even in heavy smokers. 36-S ■ JADA Supplement January 1990
Conclusions
People learn cigarette smoking behavior over time. They can also slowly and methodically unlearn smoking behavior as they gradually weaken the series of strong associations formerly linked to smoking. Thus, behavioral modification is essential in any smoking cessation program aiming to achieve long-term success. Nicotine polacrilex treatment, which replaces the nicotine formerly provided by cigarettes, is a viable adjunct when used concurrently with behavioral modification. It is important to prescribe nicotine polacrilex in dosages similar to those received from cigarettes to avoid smoking relapse. A slow and methodical reduction of nicotine polacrilex may serve as a retraining process, conditioning the brain receptor sites to accept consecutively smaller amounts of nicotine as “normal” doses, until zero nicotine intake is once again perceived as “normal.” The fact that 79.5% of heavy smokers seen at year 1 were still nonsmokers at year 3 suggests that nicotine reduction therapy (via 2-mg nicotine polacrilex administration), combined with long-term behavioral modification, provides effective smoking cessation treatment. D r. C ooper is professor, departm ent of oral health sciences, College of Dentistry at the University of Kentucky; and D r. Clayton is professor, departm ent of sociology and scientific director of the Center for Prevention Research, the University of Kentucky, Lexington. Address requests for reprints to Dr. Cooper at M-129, C handler M edical Center, Lexington, KY 40536. 1. Jarvis MS, Raw M , Russell M AH. Random ized controlled trial of nicotine chewing gum. Br J Med 1982;285:537-40. 2. Tonnesen P, Fryd V, Hansen M. Effect of nicotine chewing gum in com bination with group counseling on the cessation of smoking. N Engl J Med 1988;318:15-8. 3. Shiffman S. Relapse following sm oking cessation: a situational analysis. J Consult Clin Psychol 1982;50:71-86. 4. M arlatt GA, Gordon JR , eds. Relapse prevention: maintenance strategies in the treatm ent of addictive behavior. New York: Guilford, 1985. 5. US D ep artm en t of H ealth and H um an Services. The health consequences of smoking. Nicotine addiction. A report of the Surgeon General. W ashington, DC: US Governm ent Printing Office, 1988; D H HS publication no. (CDC) 88-8406. 6. Henningfield JE , Jasinski DR. Pharm acologic basis for nicotine replacement. In: Pom erleau O F, Pom erleau CS, eds. Nicotine replacement: a critical evaluation. New York: Alan R. Liss, 1988:35-61. 7. Kozlowski LT, W ilkinson A, Skinner W, Kent C, Franklin T, Pope M. Com paring tobacco cigarette dependence with other drug dependencies. JA M A 1989;261:898-901. 8. W arner KE. Effects of the antism oking campaign: an update. Am J Public Health 1989;79:144-51. 9. Hall SM , Tunstall C, Rugg D. Nicotine gum and behavioral treatm ent in sm oking cessation. J Consult Clin Psychol 1985;53:256-8. 10. Hall SM , Tunstall C, Benowitz NL, Jones RT. Nicotine gum and behavioral treatm ent: a placebo controlled trial. J Consult Clin Psychol 1987;55:603-5. 11. Killen JD , Maccoby N, Taylor CB. Nicotine gum and self-regulation training in smoking relapse prevention. Behav Ther 1984;15:234-48. 12. Hughes JR , Gust SW, Keenan RM . Nicotine vs. placebo gum in general medical practice. JA M A 1989;261:1300-6. 13. C ooper TM, Clayton RR. Stop-sm oking program using nicotine reduction therapy and behavior m odification for heavy smokers. JA D A 1989;118:47-51. 14. Fagerstrom KO. A comparison of psychological and pharmacological treatm ent in smoking cessation. J Behav Med 1982;5:348-51. 15. Benowitz NL. Toxicity of nicotine: implications with regard to nico tine replacement therapy. In: Pom erleau O F, Pom erleau CS, eds. Nicotine replacement: a critical evaluation. New York: Alan R. Liss, 1988:187-217.