Pharmacological Treatments

Most smokers have quit on their own or, rather, tried to quit. Although 18 million try each year, less than 7 percent do so successfully. Most of the efforts were ''cold turkey,'' good for a start, but the least effective of all techniques. Long-term abstinence rates are low for people using this method. Treatment programs are helpful in increasing rates of success, and the availability of pharmacological interventions gives clinicians additional useful tools to help the smoker. The major pharmacological approaches are nicotine replacement, symptomatic treatment, nicotine blockade, and deterrent therapy. Nicotine replacement and symptomatic treatment have become part of general medical practice. Until further information is collected, blockade and deterrent therapy must be considered experimental.

Nicotine Replacement. The rationale for nicotine replacement is to substitute a safer, more manageable, and, ideally, less addictive (more easily discontinued) form of an abused drug to alleviate symptoms of withdrawal. An example of a less-addictive substitute is Methadone Maintenance for opiate abusers. Various forms of nicotine replacement have been developed including polacrilex (gum), transdermal delivery systems (patches), nasal vapor inhaler, nasal nicotine spray (gel droplets), and smoke-free nicotine cigarettes. The forms provide different doses and speeds of dosing. These parameters may be important in offering the smoker levels of nicotine necessary to alleviate withdrawal and cravings for nicotine. Currently, only the nicotine gum and patch are approved for use in the United States.

Several advantages exist in replacing nicotine from tobacco with non-tobacco-based systems such as gum or patches. First, they do not contain all the toxins present in tobacco or produced by burning tobacco. Second, total daily nicotine administration is lower for most patients on nicotine-replacement systems, and the high initial nicotine bolus doses produced by inhaling are not delivered. Third, the clinician can control doses more effectively than with tobacco-based products. The patient cannot, for example, take a few extra puffs per cigarette and defeat the purpose of gradual nicotine-reduction plans.

Nicotine gum may not be absorbed well if the client does not follow directions carefully. From

I-UJ CO

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PERFORMANCE ("Logical Reasoning")

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BRAIN FUNCTION (Theta Power)

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NICOTINE GUM DOSE

* Significant difference from Libitum smoking + Significant difference from placebo gum

Figure 1

Cognitive Performance and an Electrophysiological Measure of Brain Function during Smoking and Abstinence with Nicotine-or Placebo-Delivering Gum Treatment.

1984 until 1991, about 1 million prescriptions for nicotine gum, the only form of nicotine replacement then available, were filled per year. At the end of 1991, nicotine patches were introduced, and approximately 7 million prescriptions were filled for all replacement systems, with the nicotine patch accounting for nearly 90 percent of new prescriptions for nicotine replacement. The popularity of the nicotine patch can be measured by the higher rate of compliance than for the only currently available alternative, nicotine gum. Nicotine gum compliance rates tend to be lower because patients may dislike the taste and experience slightly sore mouths, throats, and jaws and gastrointestinal upset. Nevertheless, a study at the Addiction Research Center of the National Institute on Drug Abuse (NIDA) found nicotine gum to be effective in treating the cognitive function and corresponding brain electrical function changes of tobacco withdrawal. The effect was stronger at higher dose levels (e.g., 4 mg; see Figure 1). Because of current prescribing practices, this section will concentrate on the nicotine patch.

Four brands of nicotine patch are currently available in the United States. All deliver a given dose of nicotine transdermally, through the skin, over either a 24-hour (Habitrol, Prostep, and Nicoderm) or a 16-hour (Nicotrol) period. No clinical study has directly compared the four brands, but there is no evidence that any one brand leads to consistently higher rates of abstinence than any other. Variations in nicotine-delivery rate and skin contact effects may mean that certain patches work better for some people than others, but there is as yet no way to tell which patch will work better for an individual patient.

The nicotine patch is highly effective, resulting in an overall doubling of smoking cessation rates. Different studies have reported cessation rates of between 22 percent and 42 percent after six months of use. The combination of intense counseling and patch use was associated with higher success rates.

Work is necessary to develop a list of characteristics of those patients most likely to benefit from nicotine patch use. The University of Wisconsin's Center for Tobacco Research and Intervention suggests that patients may benefit if they are motivated to quit and fit into at least one of the following categories:

Smoke at least 20 cigarettes per day

Smoke first cigarette within 30 minutes of awakening

Have experienced a strong craving for cigarettes during the first week of previous attempts at quitting

The nicotine patch should be applied as soon as the patient awakens, and the user should stop all smoking during patch use. The patch should be applied to a hairless part of the body, with a different site every day. The same site should not be used again for one week. Side effects include a local skin reaction at the patch application site in 30 percent of patients and possibly sleep disruption. Because the tobacco-withdrawal syndrome also may include sleep disruption, it is sometimes difficult to determine whether the sleep disturbance is a result of tobacco withdrawal or nicotine patch therapy.

The four patches vary in their recommendations for length of treatment, from six to sixteen weeks. Because no published studies have documented a benefit for longer treatment, some researchers recommend 6 to 8 weeks for most patients, but therapy should be individualized where appropriate. Other researchers have concluded that, in general, the chances of success appear better in longer-term use.

In patients with cardiovascular disease, the nicotine patch may be used cautiously, although there has been no documented association between patch use and acute heart attacks. It should be used in pregnant patients with caution—only after they have failed to quit using nondrug means. Nicotine replacement should not be given to people who continue to smoke, although the advisability of terminating therapy if only occasional cigarettes are smoked is subject to debate.

Nicotine delivered by tobacco products is one of the most highly addictive substances known. Even people highly motivated to quit may have profound difficulty doing so on their own. It is now known that people differ greatly in the severity of their addictions and their ability to cope. Our ability to treat nicotine addiction is continually improving. Even so, many people will require several repeated quitting attempts, regardless of treatment used. Therefore, long-term support by public health organizations and other facilities is essential if we are to prevent the serious diseases that will affect one in two untreated smokers.

Recent data from the 3 million people treated with the nicotine patch during its first seven months of availability in the United States increase optimism that the body can repair much of the damage caused by smoking. Epidemiological data indicate that 2,250 heart attacks would have occurred if these smokers had continued their habit. In fact, the Food and Drug Administration (FDA) received reports of only 33 severe cardiovascular problems. Even assuming underreporting, this de crease is so profound that it strongly supports the conclusion of the surgeon general in 1991 that risk of heart attacks rapidly declines after smoking cessation. These people were receiving nicotine via the patch, although probably at a lower level than if they continued smoking, and still their rate of heart attacks was significantly reduced.

Symptomatic Treatment. Nicotine administration and withdrawal produce a number of neurohormonal and other physiological effects. Symptomatic treatment methods are nonspecific pharmacotherapies to relieve the discomforts and mood changes associated with withdrawal. If the potential quitter relapses to escape the suffering of withdrawal, these methods should help to prevent such relapse. There is a long history of pharmacological treatment of smokers. To reduce withdrawal, sedatives, tranquilizers, anticholinergics, sympathomimetics, and anticonvulsants have all been tried at one time and were no more successful in helping smokers quit than was a placebo. Cloni-dine is one agent that has been tried in the treatment of nicotine withdrawal discomfort and is commonly used to treat opioid withdrawal. Glassman and his colleagues (1984; 1988) administered clonidine to heavy smokers on days they abstained from smoking and found that it reduced anxiety, irritability, restlessness, tension, and craving for cigarettes. When they gave clonidine to smokers trying to quit, 6 months later, 27 percent of those given clonidine and 5 percent of those given placebo reported abstinence. Surprisingly, clonidine seemed to be effective only for women. Among men, those given clonidine did no better than those given a placebo. Before recommending clonidine for smokers, practitioners should consider potential side effects. Clonidine has been used to treat hypertension, and abrupt termination has sometimes led to severe hypertension and in rare circumstances to hypertensive encephalopathy and death. More commonly, it may cause drowsiness, potentially dangerous to someone operating machinery or driving.

Among nicotine's effects is the regulation of mood. Smokers have been shown to smoke more than usual during stressful situations; therefore, those trying to quit often relapse (begin smoking again) during stressful situations. These observations suggest that treating the mood changes associated with abstinence with, for example, Benzodiazepine tranquilizers, Antidepressants, or psychomotor stimulants may improve abstinence rates. The benzodiazepine tranquilizer alprazolam was also examined by Glassman and his colleagues (1984; 1988) and found to reduce anxiety, irritability, tension, and restlessness, but it had no effect on cravings for cigarettes in heavy users abstaining from smoking for one day. More study is necessary on its effectiveness in maintaining tobacco abstinence.

Nicotine Blockade. Nicotine blockade therapy is based on the rationale that if one blocks the rewarding aspects of nicotine by administering an antagonist (or blocker), the smoker who seeks the pleasant effects nicotine produces will be more likely to stop. To be effective, the drug must be active in the central nervous system (brain and spinal cord). Thus mecamylamine, which acts at both central and peripheral nervous system sites, effectively increases rates of abstinence, whereas hexamethonium and pentolinium, which block peripheral nervous system receptors only, have no effect on abstinence. The problem is that there are no pure nicotine antagonists currently available. Drugs like mecamylamine produce side effects, such as sedation, low blood pressure, and fainting, that probably limit their role to that of an experimental tool, not appropriate for clinical treatment.

Deterrent Therapy. The rationale for deterrent therapy is that pretreatment with a drug may transform smoking from a rewarding experience to an aversive one if the unpleasant consequences are immediate and strong enough. Disulfiram treatment for alcoholism is an example of this type of treatment. After pretreatment, even a small quantity of alcohol can produce discomfort and acute illness. Silver acetate administration is a potential treatment for smokers. When silver acetate contacts the sulfides in tobacco smoke, the resulting sulfide salts are highly distasteful to most people. Although many over-the-counter deterrent products are available, their effectiveness has not been scientifically validated. Additionally, a severe limitation to this treatment is compliance. It may be difficult to ensure that patients continue to take the medication as needed.

BEHAVIORAL TREATMENTS

Characteristics of tobacco dependence and nicotine addiction suggest that combining nicotine replacement, to reduce the physiological disruptions of withdrawal, with behavioral treatments, to counter the conditioning cues, reinforcers, and social context cues associated with smoking, may be especially useful in helping people to quit. Adding behavioral treatments may increase both the rate of successful outcomes and the adherence to the pharmacological treatment. Behavioral interventions for smokers have been tried for many years. This section will focus on several of the current major approaches, but it is by no means comprehensive.

Social support has produced mixed results. Enlisting the help of the smoker's spouse and coworkers, or encouraging participation in a group, has yielded generally positive outcomes, but attempts to enhance social support further have been uniformly unsuccessful. Providing skills training in coping with stress and negative emotions has also been tried but generally as part of a multicompo-nent treatment plan. If the person smokes during times of stress and negative emotions, learning other means of dealing with these situations may lessen the need to smoke. Skills training appears beneficial in the short term, especially when combined with aversive smoking procedures (discussed below), but its long-term benefits are less clear. Mixed but generally negative results have been reported, but a problem in assessing skills training is that researchers have not controlled for the differences in treatments available. Some may be more effective than others. The techniques should be available for clients long after learning in order to be beneficial for long-term smoking cessation.

Contingency contracting uses operant conditioning techniques to reinforce quitting or punish smoking behaviors. Procedures include collecting monetary deposits from clients early in treatment and providing periodic repayment as nonsmoking goals are reached, having a client pledge to donate money to a disliked organization for every cigarette smoked, or similar procedures using nonmonetary rewards or punishers. Research indicates that contingency contracting aids quitting at least in the short term. Stimulus control procedures gradually eliminate situations in which the client smokes (e.g., only smoke outside) or the time the client smokes (e.g., only on the half hour) to reduce the number of cues for smoking.

Nicotine fading gradually changes brands or cigarette filters the smoker uses, in order to decrease tar and nicotine per cigarette before complete cessation. It is hoped this strategy will decrease later withdrawal symptoms when the client stops smoking. Problems are that the procedure may do nothing to reduce cravings (considered important for relapse prevention) and that the nicotine reduction is not as large as one would expect from ratings of the cigarettes' contents, because people change the way they smoke to receive more nicotine from each cigarette. Improved outcomes may occur with nicotine fading when it is part of multicomponent treatment approach.

Aversion treatments are designed to condition a distaste for cigarettes by pairing smoking with either unpleasant imagery (covert sensitization), electric shock, or unpleasant effects of smoking itself through directed smoking procedures. Directed smoking techniques include satiation, rapid smoking, and focused smoking. In satiation, clients smoke at least at twice their regular rate. Research indicates a low, 15 percent success rate when satiation is used by itself, versus 50 percent when it is part of a multicomponent program. In rapid smoking, clients inhale every 6 seconds until they will get sick, usually for six to eight sessions. As part of a multicomponent program, good outcomes are seen, but success is variable when rapid smoking is used alone, with high immediate abstinence rates, followed by low long-term rates. In focused smoking, clients either smoke for a sustained period at a slow or normal rate or do rapid puffing without inhaling. Long-term outcomes are similar to or slightly lower than for rapid smoking. The utility of aversion procedures is limited because the aversions are rarely permanent, and it is difficult to condition aversion to a substance that has had repeated past use.

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