Methadone Treatment in Narcotic Addiction: Chapter 10

Introduction

There are almost as many distinctive addiction treatment approaches as there are individual programs; even where the administration of methadone forms a common bond among different programs, the philosophies, policies, and procedures are widely divergent. The unique feature which characterizes the original "methadone maintenance" approach introduced ten years ago is the acceptance of methadone as a medication, devoid of any inherent negative value: the drug is used in order to achieve a desired clinical result; effectiveness is measured solely by improvement in the patient's status; the dosage of the drug is not a criterion of treatment outcome; and the treatment regimen is continued until it no longer elicits the desired response, or until the underlying condition is resolved.

In all these respects, the management of narcotic dependence proposed by Dole and Nyswander parallels the medical treatment of other illnesses. In most clinical situations, the amount of medication prescribed is recommended on the basis of experience, and in the absence of serious side effects attendant to the use of a drug, the "conservative" approach is generally to give more rather than less, in order to provide a margin of safety. Even where the drug employed is an addictive, abusable substance such as a barbiturate, the same orientation applies; in the management of epilepsy with phenobarbital, the primary focus is on controlling the disease, and moral qualms regarding the prescribed dosage or duration of medication do not justify subjecting patients to the risk of persistent seizures. Moral qualms, however, have pervaded the field of methadone maintenance treatment since its inception, and consequently the regimen introduced a decade ago has been drastically altered.

Methadone Maintenance: The Basis for Dissonance

In introducing methadone maintenance as a new therapeutic approach to drug addiction, Dole and Nyswander recognized that the anticipated opposition would be based on moral rather than medical grounds. There was a deep-rooted belief that "...prescription of medication would do no more than gratify a bad habit, and therefore that it could not possibly contribute to rehabilitation" (149). The American Medical Association, as early as 1921, had urged "...an end to all manner of so-called ambulatory [i.e., maintenance] treatment of narcotic addicts" (150). In a joint statement with the National Research Council in 1963, only weeks before Dole and Nyswander initiated clinical studies with methadone, the Association reaffirmed its position: "Continued administration of drugs for maintenance of addiction is not a bona fide attempt at cure, nor is it ethical treatment [of addiction]..." (lxiv). An equally unambiguous condemnation of maintenance treatment had been voiced earlier by the Judiciary Committee of the United States Senate: "We believe the thought of permanently maintaining drug addiction with 'sustaining' doses of narcotic drugs to be utterly repugnant to the moral principles inherent in our laws and the character of our people" (153). The unprecedented results of the Dole-Nyswander treatment did not change the prevailing attitudes, and as late as 1970 the American Medical Association continued to question the propriety of substituting methadone for heroin and "...maintaining such dependence for an indefinite period, perhaps for life" (154).

The fact that nonnarcotic drugs used in the management of substance abuse are generally free of controversy indicates that the rejection of methadone maintenance treatment is based on the moral, and irrational, premise that methadone "substitutes vodka for gin." The dosage of Antabuse employed in alcoholism is rarely the subject of discussion, let alone debate, and "weaning" the former alcoholic from Antabuse is a goal which is viewed with almost total indifference by the clinician, the patient and the general public. These issues are similarly inconsequential with respect to narcotic antagonists: few workers in the field know or care what the "usual" or "best" dose of cyclazocine or naltrexone is; little attention has been focused on the optimal means of discontinuing the administration of these drugs; and no attempt has been made by regulatory agencies to limit the number of months that they may be prescribed. The critical difference between these drugs and methadone is that the latter is pharmacologically classified as a narcotic. The conclusion is inescapable: methadone remains identified as a euphorigenic drug which exerts its influence by keeping patients "doped up," all the facts to the contrary notwithstanding.

The assumption that the administration of any narcotic, under any circumstances, will produce euphoria is simply inaccurate. The initial, carefully controlled studies by Dole and Nyswander demonstrating that patients maintained on constant doses of methadone experience no mood- altering effect from the drug have been confirmed by other, independent investigators; they have been considered beyond dispute by knowledgeable clinicians and pharmacologists for many years. Nevertheless, the medical community's bias against maintenance treatment with narcotics has remained largely impervious to the facts:

In one of the earliest articles denouncing methadone maintenance treatment, published in the Journal of the American Medical Association as a "Critical Commentary;" the author concluded: "'Stabilization,' in other words, is just a euphemistic term to indicate that when heroin addicts receive a sufficiently high euphorogenous dose of methadone, they no longer have any craving for the euphorogenous effects of heroin" (155) (lxv).

A medical journal article asserted that methadone maintenance patients were reduced to "narcotized zombies" (158).

Some clinicians, having experienced the frustrating failure of other forms of addiction treatment, viewed the success of methadone maintenance as proof that the medication must produce "psychic gratification" (159), and reasoned that persons on methadone are "...satiated to the effects of opiates and, therefore, demonstrate reduced illicit heroin self-administration" (160).

Dosage and Duration of Treatment:
Changing Attitudes

In introducing methadone maintenance treatment, Dole and Nyswander defined the pharmacological objectives as: "(1) the relief of narcotic hunger, and (2) induction of sufficient tolerance to block the euphoric effects of an average illegal dose of diacetymorphine [i.e., heroin]" (161). The importance of the latter effect was underscored in 1966, when the Committee on Problems of Drug Dependence of the National Research Council defined the Dole-Nyswander research with methadone as a "...project serving to test the hypothesis that ... the administration of methadone in amounts sufficient to produce a high level of tolerance, will result in the narcotic dependent person losing his inclination toward continued abuse of illicit narcotics" (162, emphasis added). Four years later, in 1970, the World Health Organization Expert Committee on Drug Dependence still described methadone maintenance as "...the continuing daily oral administration of methadone under adequate medical supervision, the dose being adjusted (a) to prevent the occurrence of abstinence phenomena, (b) to suppress partially or completely any continuous preoccupation with taking of drugs of the morphine type [i.e., to suppress "drug hunger"], and (c) to establish a sufficient degree of tolerance and cross-tolerance to blunt or suppress the acute effects of such agents" (163, emphasis added). One of the hallmarks of the original methadone maintenance concept, therefore, was the use of medication to establish a high degree of tolerance to narcotics. Although the early programs frequently relied on dosages in the range of 80-120 mg of methadone to achieve this effect, the specific dosage used for an individual patient was generally viewed with disinterest. The focus was on the patient, and the patient's response to treatment.

The dramatic increase in the late 1960's and early 1970's in the number of addiction treatment programs throughout the country utilizing methadone, however, was accompanied by a growing preoccupation with lowering the maintenance dosage. Decreasing the amount of medication prescribed became an end in itself, for which the rationale was considered so self-evident that it required no elaboration. Those program directors who did seek to explain their departure from the original, highly successful protocol pointed to experimental studies which alleged that treatment outcome is not appreciably affected by dosages used. In this connection the most widely publicized findings have been those of Goldstein and his co-workers (164-167). The double-blind research design employed in these studies, however, which prevented both the patients and the staff from knowing the dosages prescribed, created an artificial setting wholly different from that of programs which adjust dosages on the basis of individual patient assessment, and make no secret of the amount prescribed (lxvi). Consequently, the experimental conclusions have little relevance to the clinical management of patients. This was evident in subsequent studies by Goldstein, in which patients were not only advised of the dose of methadone ordered, but allowed (within limits) to make adjustments themselves; under these circumstances, a reduction in heroin use was associated with dosage increases in some cases (170). Whether these findings are the result of psychological or pharmacological factors, or both, there are indeed patients who do better, objectively and subjectively, when maintained at dosages of approximately 100 mg than at lower levels.

Nevertheless, increasing numbers of clinicians have lowered the amount of methadone which they are willing to prescribe, and established inflexible upper limits of 60 mg, or less. The debate between low-dose advocates and those who continue to prescribe higher doses has received considerable attention, and unfortunately has obscured the more fundamental issue: assuming the results of treatment are satisfactory, why should it matter whether they are achieved with 50 or 150 mg of methadone? Rigid policies of uniform adherence to any dosage conflict with the axiom that medical treatment should be based on the clinical course of the individual patient. The concern of program staff with dosages rather than patients, however, is the rule rather than the exception (lxii).

Preoccupation with lowering the maintenance dosage of methadone has been exceeded only by the emphasis which total detoxification has received. In a step which is without precedent in the practice of medicine, a limit has been imposed on the duration of methadone maintenance treatment; the Food and Drug Administration now demands that a physician provide written justification for extending the administration of methadone beyond the arbitrary time frame which is permitted (lxviii). The F.D.A. explicitly acknowledged the political pressure which motivated its decision: "The Honorable Paul G. Rogers, Member of Congress from Florida, Chairman of the Subcommittee on Public Health and Environment of the Committee on Interstate and Foreign Commerce, U. S. House of Representatives, has written the Commissioner of Food and Drugs to request revision of the regulations governing methadone ... to include a requirement for discontinuance of methadone after 2 years of treatment unless, based on clinical judgment, the patient's status indicated that treatment with methadone should be continued for a longer period of time" (173). According to the perverted logic underlying this ruling, the fact that a patient is doing well is presumptive evidence that treatment should be terminated, and only in those cases where therapy has been relatively unsuccessful can its continuation be condoned.

Departing from its usual practice of soliciting public comment prior to promulgating new regulations (174), the F.D.A. explained that the imposition of a time limit with respect to methadone treatment was immediately necessary in order to "...protect the health and safety of patients treated with methadone" (175). Although this claim was totally unsupported by the extensive data regarding the effects of long-term methadone administration, the message conveyed to patients as well as staff was that methadone treatment is a dangerous and undesirable modality which can only be tolerated as a temporary expedient.

Conclusion

In retrospect, the most destructive impact on methadone maintenance treatment has come from the seemingly more moderate critics who tolerated the use of methadone, but with certain qualifications, especially with respect to dosage and duration of treatment. The "endorsement by the Federal Government of the methadone maintenance treatment modality," (176) and its "strong commitment to the ... massive expansion of methadone maintenance programs throughout the country," (177) has amounted to no more than the grudging approval to utilize methadone, but only within a therapeutic framework diametrically opposed to that which formed its original foundation. Today, the utilization of methadone represents only a modification of the drug-free approach, and a total repudiation of methadone maintenance treatment as employed so successfully by Dole and Nyswander and the few early programs that sought to emulate their experience. Despite the fact that administration of methadone for more than 21 days continues to be labeled "methadone maintenance," this form of treatment no longer exists.

Notes

lxiv. This position was warmly endorsed by the Bureau of Narcotics in a "Concurring Statement": "The Bureau is pleased to note that the American Medical Association has reaffirmed its position opposing the establishment of community ambulatory clinics for ... the continuing maintenance of addicts on narcotics" (152).

lxv. An article by the same author, in which he states that methadone maintenance involves "... simply substituting the euphoric action of methadone for the euphoric action of heroin by administering massive doses o the former," (156) was reprinted in 1968 by the New York State Narcotic Addiction Control Commission as an "especially noteworthy article on narcotic addiction" which deserved a wider audience (157).

lxvi. In the early months of operation, the NYC MMTP attempted to keep patients from knowing their dosages, and noted an almost universal preoccupation with dosage levels; virtually all patients believed the amount prescribed was either too high or too low. The adverse effect of this anxiety, which has also been reported by other programs (168, 169), may overshadow differences in treatment outcome associated with various dosage levels.

lxvii. This orientation is shared by the Federal Food and Drug Administration, which has decreed that when more than 100 mg are prescribed by the physician, daily clinic attendance is mandatory; the degree of social rehabilitation demonstrated by the patient is totally inconsequential (171).

lxviii. The orientation which this regulation reflects has been espoused by the former Director of the National Institute of Mental Health, Division of Narcotic Addiction and Drug Abuse (the forerunner of the National Institute on Drug Abuse): "It is most important to recognize methadone maintenance for the crutch that it is, a temporary support which is to be discarded as a soon as the client has changed his sick attitudes, values and rationalizations" (172).