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COMMON MISUNDERSTANDINGS

Much of the uneasiness about methadone stems from the idea that it is "just substituting one addicting drug for another." Indeed, this is technically correct; methadone treatment is drug-re-placement therapy in which a long-acting, orally administered preparation is substituted for a short-acting opioid that is used intravenously. The long-acting (24 to 36 hours) effect of preventing withdrawal allows most patients to receive a dose and function in a stable manner, without the four-hour cycles of euphoria and withdrawal that characterize heroin use. The objection that methadone is "addicting" reflects the recognition that the medication is dependence-producing. Addiction treatment professionals increasingly distinguish between physical dependence and addiction, the latter being characterized by behavior that is compulsive, out of control, and persists despite adverse consequences. Chronic-pain patients will develop physical dependence though their overall functioning is improved. Appropriate prescribing of benzodiazepines for patients with anxiety disorders is another example of another dependence-producing drug used beneficially for thousands of patients. Although physical dependence is a factor to be considered, addiction specialists increasingly assess the extent to which the person's functioning and quality of life are improved or impaired in order to determine whether physical dependence is an acceptable consequence of medication use.

Another point of discord is the belief that "methadone keeps you high," a notion that reflects misunderstanding about the effects of a properly adjusted dose. Once stabilized, most patients experience little or no subjective effects; heroin addicts will readily state that they seek methadone to avoid becoming sick (prevent withdrawal effects), not to get high. When the patient's dose is being stabilized, he or she may experience some subjective effects, but the wide therapeutic window allows for dose adjustment between the points of craving and somnolence. Dose adjustment may take some weeks and may be disrupted by a variety of medical and lifestyle factors, but once achieved the patient should function normally. There is ample scientific evidence that the long-term administration of methadone results in no physical or psychological impairment of any kind that can be perceived by the patient, observed by a physician, or detected by a scientist. More specifically, there is no impairment of balance, coordination, mental abilities, eyehand coordination, depth perception, or psychomotor functioning. Recently, advocacy efforts have been successful on behalf of patients identified through workplace drug testing and threatened with negative consequences. It is anticipated that the Americans with Disabilities Act will further protect patients against such forms of discrimination.

A third point of resistance, objection to long-term or even life-long maintenance, is better addressed following the presentation of some basic information about opioid addiction and the nature of treatment.

HOW DOES METHADONE TREATMENT WORK?

Most addiction specialists agree that addictive disorders are complex phenomena involving the interaction of biologic, psychosocial, and cultural variables, all of which need to be considered to make treatment effective. Dole and Nyswander, who pioneered the use of methadone, held the view that there was something unique about opioid addiction that made it difficult for patients to remain drug-free. Although originally intended as a long-term treatment for a metabolic defect, many initially hoped that methadone could be used to transition heroin addicts to a drug-free lifestyle and then be discontinued. Research in the subsequent 30 years indicates that less than 20 percent will be able to discontinue methadone and remain drug-free. As his thinking evolved, Dole (1988) postulated that a receptor system dysfunction resulting from chronic use leads to permanent alterations which we do not currently know how to reverse. New brain imaging technology holds the promise of better understanding and, eventually, improved intervention, but in the interim it appears that methadone is corrective although not curative for the severely addicted person. Two important questions for future research are whether a preexisting condition enhances the vulnerability of some patients more than others, and whether long-term addicts can ever recover normal functioning without maintenance therapy.

For now, studies indicate that methadone is a benign drug which exhibits stability of receptor occupation and thus permits interacting systems to function normally. One example of this is the normalization of hormone cycles and the return of regular menstrual cycles in women. This distinguishes it from heroin, a short-acting narcotic producing rapid changes that make a stable state of adaptation impossible. Although tolerance develops to most effects, it is fortunate that even long-term use (30 years or more) does not produce tolerance to the reduced craving, or to the narcotic withdrawal prevention effect.

The desired response to methadone depends on maintenance of a stable blood level at all times. Appropriate doses usually keep the patient in the therapeutic range of 150 to 600 ng per mL in the blood and produce the stable state so important for rehabilitation. What is referred to as a "rush" or "high" is the result of rapidly changing blood levels; thus, once therapeutic levels are achieved and maintained, the patient experiences little subjective effect.

Unfortunately, negative attitudes toward methadone have historically played a significant role in dosing practices, manifested in dose ceilings imposed by state or local regulations without regard to medical criteria. Such policies placed value on giving as little of the drug as possible (versus the therapeutic level needed to accomplish the goal), influenced in part by the belief (unsubstantiated) that lower doses would make it easier to discontinue methadone. It was common to have dose ceilings of 40 mg per day. It is now well established that this is inadequate to maintain the necessary plasma concentrations to be effective; the effective range is between 60 and 120 mg per day for most patients, with some needing less than 60 and others considerably more than 120 mg. The higher and more adequate doses are strikingly well correlated with reductions in illicit drug use and improved retention in treatment (GAO, 1990; Caplehorn & Bell, 1991). How painfully ironic to recall that patients on low doses who complained that "my dose isn't holding me" were often dismissed with the assertion that they were "merely engaging in drug-seeking behavior." And when the distressed patient then supplemented the methadone dose with heroin, it was concluded either that the patient was poorly motivated, or the treatment was ineffective. Studies by D'Aunno and Vaughan (1992) show that more than 50 percent of patients nationwide receive doses that are inadequate to prevent continued illicit narcotic use, indicating both poor physician training and inappropriate involvement by regulatory agencies and legislative policies.

Initial hopes to use methadone as a drug to transition patients to a medication-free life style have proven unrealistic. Studies indicate that although short-term abstinence is common, relapse is the norm for 80 percent or more (McLellan et al. 1983; Ball & Ross, 1991). Clinicians who have worked with this population over the long term believe that although lifestyle changes are essential to successfully discontinuing methadone, such changes in conjunction with high motivation will still be insufficient for most; neurobiological factors remain a deciding factor. Because the current treatment system, overburdened by regulations and inappropriate expectations, is dehumanizing for many, programs usually make efforts to assist the patient who wishes to taper off methadone. However, many of these programs attempt to create an environment in which the patient is encouraged to succeed, but also to resume methadone treatment promptly once relapse or the likelihood of it occurs.

METHADONE AND OTHER DRUG USE

Methadone patients may engage in alcohol, cocaine, and other drug use prevalent in their communities. It is important to remember that methadone is opioid-specific and does not in itself increase or prevent other kinds of drug use. It does, however, offer the enormous advantage of making the patient accessible to other kinds of intervention. Rules governing take-home medication are intended to reduce the diversion of methadone onto the illicit market. At minimum, they mandate that the patient come to the clinic at least once weekly and, in most cases, even more frequently. Thus, the patient can be exposed to educational presentations and materials, and to counseling interventions as indicated by an individualized treatment plan, which is required as part of the treatment effort. Cocaine use has received particular attention, as it has been identified as increasing dropout, slowing progress, and undermining the gains of previously stable patients. Research and training efforts have been brought to bear on this problem. Alcohol use remains a problem, particularly since many patients define their difficulty in terms of illicit drug use and are resistant to the notion of giving up drinking. With the blending of the "cultures" of alcohol and drug treatment providers, counselors are increasingly sophisticated about addressing problem drinking, although it is uncommon for programs to define goals for everyone in terms of abstinence from all intoxicants, as other parts of the treatment system do. Nonetheless, there is increasing sophistication in interventions, and programs have the added advantage of being able to dispense disulfiram with methadone when appropriate.

TREATING OPIOID-ADDICTED PREGNANT WOMEN

Methadone maintenance has been viewed as an effective treatment for opioid addiction in pregnant women since the early 1970s. In addition to the benefits of psychosocial interventions provided by the program, methadone maintenance treatment prevents erratic maternal opioid drug levels, thus protecting the fetus from repeated episodes of withdrawal. Programs either provide prenatal care onsite, or monitor the patient to see that prenatal care is obtained elsewhere, thus reducing the incidence of obstetrical and fetal complications, in utero growth retardation, and neonatal morbidity and mortality (Finnegan, 1991). Exposure to HIV infection through ongoing needle use is also reduced. Programs typically provide interventions around nutrition, parenting skills, exercise, and other related topics.

Methadone-maintained mothers produce off-spring more similar to drug-free controls, in contrast to the poorer health status of offspring born to women using street drugs. It is clear that the most damaging consequences of opioid use during pregnancy occur with repeated episodes of intoxication and withdrawal (Jarvis & Schnoll, 1994). Although expectant mothers can be stabilized on methadone, body changes specific to pregnancy cause them to frequently develop increasing signs and symptoms of withdrawal as the pregnancy progresses, and they may need dose increases in order to maintain therapeutic plasma level and remain comfortable. Splitting the dose so that it can be ingested twice daily often produces better results, both reducing fetal stress and increasing the comfort of the pregnant woman, but local regulatory obstacles, not allowing patients to take half their daily dose out side the clinic, make this impractical for many programs.

There is inconsistent evidence to support the commonly held belief that the severity of the neonatal abstinence syndrome is proportional to the methadone dose, but many programs urge the expectant mothers to reduce their dose so the "baby won't be born addicted." In fact, the management of neonatal abstinence syndrome is relatively straightforward; fetal discomfort can usually be eliminated within hours and withdrawal can be accomplished within 14 to 28 days. No lasting impairment from these experiences has been demonstrated.

ADDRESSING PSYCHOSOCIAL ISSUES

Many existing methadone programs fall far short of the resources needed to do an effective job, but extensive research over a long period of time has clarified many of the treatment tasks. The stigma against heroin addicts in general and methadone patients in particular has created a treatment climate in which both patients and treatment providers may become demoralized about the value of the treatment endeavor. Often isolated from the mainstream, providers may not be able to obtain access to resources for patients on methadone. For example, methadone patients are often excluded from housing support or residential treatment. Nonetheless, there exists growing documentation that minimal intervention using methadone does reduce illicit drug use and hence needle sharing, and enhanced treatment accomplishes a great deal more (McLellan et al., 1993).

Historically, drug counseling has been provided in clinics by counselors who often have no credentials but are provided some training onsite. This counseling focuses on managing the patient's personal problems: problems specific to drug use, physical health, interpersonal relationships, family interactions, and vocational and educational goals. The counselor also performs the role of the case manager and is a liaison between physicians and medical institutions, courts and social services. Counselors also help the patient to develop coping strategies for current problems, perform initial screening for medication and other program services, and attend to issues concerning program rules, privileges, and policies. The regulations governing methadone treatment are more complex, detailed, and restrictive than others in medicine or psychology, and maintaining a therapeutic alliance while meeting these obligations is a daunting task for clinical staff.

Studies of the drug-dependent population indicate that over 50 percent have a comorbid psychiatric disorder (Regier et al., 1990), and among the opioid-dependent population, depression is particularly common. Treatment outcome is improved by adding supplemental psychotherapy with professionally trained staff (Woody et al., 1983) for patients who meet the criteria for high psychiatric severity. It is important that such staff be well integrated into the treatment team. Medication may also be given concurrent with methadone, and methadone patient's use of antidepressants is increasingly common. Possible interaction effects are manageable with consistent monitoring and good staff teamwork. Psychotic conditions are relatively less frequent, but clinics are likely to have some highly disturbed individuals as part of their population and hence should be able to recognize and manage these patients appropriately. The patients benefit from the structure of frequent clinic attendance combined with the low psychological intrusiveness possible within the program.

It is also desirable for vocational interventions to be integrated into the program's mission, although the economic conditions in many urban areas also necessitate the development of alternatives to bring structure to daily life. Parenting classes that provide information and skill training and the opportunity to explore related issues are often well received by parents who feel the absence of good role models and skills.

Since twelve step programs actively promote abstinence from all potentially addictive drugs, this has been a barrier to methadone patients participating in them. Coupled with this are negative attitudes toward methadone and its users. Medication interventions such as methadone were not compatible with twelve step program participation in the minds of the Alcoholic's Anonymous' founders (Zweben, 1991), but meeting participants nonetheless may not always be open to methadone patients. In recent years, this climate has begun to change and methadone patients have started to increasingly attend twelve step meetings. Methadone maintenance programs are developing their own special meetings onsite, which in turn encourage patients' utilization of twelve step meetings in the larger community.

HIV/AIDS AND HEPATITIS C

A positive reexamination of methadone treatment has been greatly stimulated by documentation of its role in reducing the spread of HIV. Seroprevalence is much lower among those who have been on long-term maintenance, particularly those who entered treatment prior to the onset of the rapid spread of HIV in the local population (Hartel et al., 1988; Batki, 1988). Clinics provide accessibility to large numbers of intravenous drug users, making them an excellent site for prevention and education, screening, testing, and counseling. Because methadone patients have a continuing forum to discuss their life issues, counselors may be able to facilitate behavior change around the issues of safer sexpractices and other high-risk behaviors. Further gains accrue as the patient progresses in treatment, as an abstinent person is in a better position to exercise good judgment than an intoxicated one. Currently, efforts are being made to integrate HIV/AIDS-related activities as fully as possible into methadone treatment programs.

The hepatitis C virus (HCV) has emerged as a problem of major significance, with many clinics reporting a prevalence upwards of 80 percent. Among those with HIV, coinfection with HCV is high. Inasmuch as 50 to 80 percent of new injectors become infected with HCV within 6 to 12 months, methadone maintenance will not reduce its spread as effectively as has occured with HIV. However, it does provide a structured system in which the patient can be monitored for good medical care, informed of emerging treatments, and educated about health practices to reduce the burden on the liver while more promising treatments are being developed.

WHAT THE FUTURE HOLDS

Methadone maintenance has demonstrated its effectiveness in reducing illicit drug use and facilitating the transition to a productive lifestyle. In the mid to late 1990s, two major scientific bodies reviewed the evidence on methadone maintenance and concluded it was an effective modality whose usefulness was greatly reduced by stigma and over regulation (National Consensus Development Panel on Effective Medical Treatment of Opiate Addiction, 1998; Rettig & Yarmolinsky, 1995). The documents produced by these groups have been instrumental in efforts around the country to reduce barriers and make the delivery system more flexible and responsive to patient needs.

Research including long-term followup indicates that stabilized and socially responsible methadone patients can be safely given a month of take-home medication by physicians in an office-based practice (Novick & Joseph, 1991; Novick et al., 1994). The federal government is in the process of formulating guidelines and regulations to permit treatment to occur in the office of a physician affiliated with a methadone clinic. For the patient, this represents a significant opportunity to shift from the traditional treatment system, segregated from the rest of medical practice since the 1960s, to the mainstream medical system. Although these changes are likely to be implemented most easily with stabilized methadone patients, pilot programs are underway to admit new patients (such as those in rural areas) to an office-based practice. Concurrently, the development of an accreditation mechanism is intended to simplify regulations and emphasize clinical practice guidelines that are more easily modified in response to emerging research findings. These activities will likely reduce barriers to treatment and allow for the development of less restrictive treatment settings.

Other maintenance pharmacotherapies, particularly LAAM and buprenorphine, have been developed and will broaden the options and possibilities for effective intervention. Federally sponsored training efforts have improved the quality of care and will continue to be essential to disseminating current information and providing opportunities for skill development. Slowly, patients have emerged as visible examples of success and to serve as role models for others. Barriers to participation in residential treatment are beginning to be removed. It is hoped that developments will engender future gains and allow this modality to gain the acceptance it so greatly deserves.

JOAN ELLEN ZWEBEN, PH.D.

J. THOMAS PAYTE, M.D.