The purpose of this Treatment Improvement Protocol (TIP) is to develop guidelines
to assess the needs of patients in opioid substitution therapy and to match
patients, based on their needs, to a variety of services, including medical, psychiatric,
social, and other support services. Several studies show that patients who receive
the services they need are more likely than others to stay in treatment and
to have positive outcomes. The concept of matching patients to services according
to their needs is widely accepted in other medical treatment settings but
until recently was not used in the field of opioid substitution therapy. This
TIP details the current knowledge about patient matching in opioid substitution
therapy; its goal is to help programs more fully develop the important aspects of
treatment that derive from matching strategies.
Another TIP in this series, State Methadone Treatment Guidelines, presents
a structure for States to follow to comply with Federal regulations when
providing methadone treatment (the most common form of opioid substitution therapy).
The methadone document describes the best treatment practices in separate
chapters on admissions procedures, dose determination, use of urinalysis as a clinical
tool, take-home medication, and patient retention. The methadone guidelines discuss
the provision of methadone treatment to pregnant women, multiple substance
abusers, and persons with human immunodeficiency virus/acquired immune deficiency
syndrome (HIV/AIDS) and other infectious diseases. The TIP on methadone also discusses
matching strategies.
The current TIP focuses on ways to develop matching strategies on a comprehensive,
programmatic level. This TIP and the previous one provide useful information about
the best practices for providing opioid substitution therapy and about how
to improve patients' chances for recovery by matching services to patient
needs.
This document on patient matching continues the efforts of the Center for Substance
Abuse Treatment (CSAT) to ensure that opioid substitution therapy programs throughout
the United States provide high-quality, cost-effective services. Two other
TIPs LAAM in the Treatment of Opiate Addiction and Assessment and Treatment
of Cocaine-Abusing Methadone- Maintained Patients provide information
on delivering the highest quality and most cost-effective treatments to the
broadest range of persons with opiate dependence.
In addition, this TIP on patient matching describes a further evolution of
opioid substitution therapy as an effective treatment. The epidemics of AIDS
and tuberculosis (TB) and the advent of managed care have a strong influence
on opioid substitution therapy programs. These epidemics make it more important
than ever that programs find ways to address the wide range of patient needs,
retain patients in treatment, and use resources efficiently. Patient matching
is a critical strategy in attaining these goals.
In recent years, phased treatment models have been developed to help planners
and providers better conceptualize opioid substitution therapy to improve
service delivery and resource allocation. This document presents a six-phase treatment
model, which includes an initial evaluation and an ongoing assessment of progress;
it describes patient treatment needs during each phase and the types of
services that can best meet these needs. Since effective patient matching depends
on careful ongoing assessment, this TIP outlines the assessment process and
describes clinical indicators for transition to other treatment phases. It also
reviews treatment elements, including a core group of treatment and support services
and a variety of counseling and therapeutic services that will enable opioid
substitution therapy programs to meet patient needs via matching strategies.
Also addressed are the issues of program self-evaluation and cost-benefit analysis
to help programs stay responsive to the realities of managed care and to provide
input into managed-care policies and decisions.
Managed care is an evolving process that was first developed in the private sector,
mainly for individuals who are regularly employed. It was only recently applied
to the public sector and to opioid substitution therapy programs. Many States
are moving toward the use of a managed care model to provide healthcare services
to Medicaid patients. The public sector, especially substitution programs,
has large numbers of chronically ill and disadvantaged persons with multiple
problems. Persons with multiple and chronic problems present a special dilemma for
managed care programs, which traditionally focus on achieving cost savings by reducing
or denying services. This strategy may be cost effective when applied to
relatively healthy persons with illnesses that are usually time limited; it may be
counterproductive if applied unwisely to opioid substitution therapy, which is a long-term
process.
On the other hand, the managed care approach has considerable potential to
facilitate treatment matching within opioid substitution therapy programs, provided
that the managed care entity is held responsible for treating the medical, psychiatric,
family, social, and other problems of patients in the program's care. When managed
care organizations attempt to help the patient to obtain the most cost-effective
medical, psychiatric, and other services for opioid substitution therapy, they do
so within the opioid substitution programs. Emergency psychiatric and medical
hospitalizations can be reduced when appropriate outpatient treatment and preventive services
are provided to persons who are high users of inpatient treatment.
Thus, managed care, rather than being regarded as a nemesis for opioid substitution
therapy, can be seen as having the potential to support this treatment, especially
in regard to developing effective matching strategies. The reasons are financial.
Very high costs result when patients are hospitalized. Most opioid-dependent
patients are potential frequent users of hospital beds -- for detoxification or
for psychiatric, medical, surgical, or other conditions that may or may not
be related to their substance use disorder. It is most cost effective to
prevent hospitalization (including emergency room use) by ensuring that opioid
substitution therapy programs have the professional resources necessary to develop effective
psychiatric, medical, and other matching strategies.
Many of the services described in this TIP have not been routinely available
to most substitution therapy programs. However, they may become more available
when managed care organizations fully realize the cost savings that can be achieved
by using matching strategies and outpatient professional services to prevent
hospitalization and other more expensive treatments. If this view is held, managed care
could help opioid substitution therapy programs to become the backbone of an
effective outpatient, medical, and psychiatric treatment delivery system, which functions
to reduce overall health costs for a group of patients who are high users
of expensive inpatient services.
Many States currently lack a model to assess the appropriateness of treatment
levels and patient matching in opioid substitution therapy programs. Models could
be based on those being considered for treatment of other chronic diseases,
such as HIV infection, that recognize the chronic nature of the condition and
the need for extended therapy. It is very important that opioid substitution
therapy programs work with managed care companies to establish assessment and treatment
guidelines that are both cost effective and that match the needs of the patients.
Patient matching is the process of individualizing treatment resources to patient
needs and preferences. It requires an assessment of the extent, nature, and
duration of the individual's alcohol and other drug (AOD) use and treatment history,
as well as an assessment of medical, psychiatric, and psychosocial needs and
functional status. The patient's gender, culture, ethnicity, sexual orientation,
and language are of key importance. Matching is a participatory activity that
involves both the clinician and the patient. Also important is the patient's motivation
as well as the level of support available to the patient to achieve and maintain
a life-style free of AOD abuse.
Most patients who require opioid substitution therapy have long-term, chronic
addiction ailments that cause serious problems in many life areas. Patient matching
should be undertaken with the understanding that many persons who are addicted
to opioids have multiple needs. Because of the complexity of patients' needs
and the scope of services required, matching is best accomplished through a
three-step process that involves 1) assessing, 2) selecting the most suitable treatment
modality and site, and 3) identifying the most appropriate ancillary services.
An individualized treatment plan with well-defined short- and long-term goals
is the product of the patient-matching process. This plan is reevaluated
at regular intervals to determine if it should be modified in respect to new
issues that may arise as earlier identified problems are resolved.
Data from matching studies have become available only within the last 10 to
15 years, and thus the subject of this TIP is relatively new. In addition,
the available data address relatively few of the many areas that could be investigated
in this complex subject. However, the available data indicate that matching
increases the likelihood of positive treatment outcomes. Provision of individualized,
comprehensive services were shown to increase rates of retention in treatment (Condelli, 1993; Joe et al., 1991); the longer a
patient is in treatment, the better the chances for recovery.
Matching also improves resource allocation by ensuring that patients receive the
appropriate level and type of services. It ensures appropriate use of the specific
training and experience of all members of the multidisciplinary clinical team, thereby
increasing the quality of care as well as team members' job satisfaction. The short-term
cost of providing individualized, professionalized services may be higher than
that of providing more limited care. However, the ultimate cost to the healthcare
system and to society, as measured in terms of increased productivity and reduction
in criminal activity, is likely to be greatly reduced.
The idea of patient matching, while not new, has become more attractive in
the wake of pressures to contain the overall cost of healthcare, particularly
if matching in an outpatient setting can reduce the need for hospitalization.
Nonetheless, the concept of matching is as methodologically elusive to
researchers as it is attractive to clinicians (McLellan and
Alterman, 1991), and many of the basic concepts of patient matching have not
yet been clearly defined or fully accepted. As additional data becomes available,
these problems may be resolved.
One example of the early development of the concept of patient matching within
the substance abuse treatment field is that, despite the existence of detailed
Federal and State regulations, methadone treatment services and outcomes vary dramatically
from program to program (Ball and Ross, 1991;General Accounting Office, 1990). Some programs are still
basing patient management decisions on outdated clinical paradigms that are not
consistent with current research findings. For example, many programs administer
low dosages of methadone (i.e., 25-40 mg as the average) in the belief that
lower is better, despite the abundant research supporting the efficacy of higher
dosages (60 mg or more), with dosage levels individualized for each patient. Further,
some programs encourage time-limited treatment rather than long-term substitution
therapy. In these cases, clinical practice does not reflect research findings that
demonstrate the efficacy of higher doses and long-term, very extended, or even indefinite
treatment.
In other cases, State regulations prohibit the use of methadone in settings
and modalities that are an important part of treatment matching and the continuum
of care. For example, consider the case of a homeless patient who might do
well on substitution therapy if he or she had a stable living arrangement; however,
the housing or shelter that could provide such an arrangement does not admit
persons on methadone. Another example is the case of a methadone-maintained patient
who needs brief hospitalization for medically supervised withdrawal (detoxification)
from another substance, but the detoxification program does not allow the patient
to be maintained on methadone during the process.
This TIP describes the problems and points out rules that need attention and
revision. As a result, it is hoped that some regulations will be modified to become
more consistent with an integrated, comprehensive system of treatment that includes
patient matching within a continuum of care.
The lack of resources and staff to provide an appropriate range of services
is an impediment to developing matching strategies within the current AOD,
health, psychiatric, and social service systems. There is a tendency in some programs
to wall off substance abuse treatment from other services, as if to say, "We
are responsible only for the substance use disorder and nothing else." This
type of organizational structure is a significant obstacle to the use of effective
matching strategies and often inconveniences the patient to the point that he or
she does not comply with important treatment recommendations. In addition,
it runs counter to AOD provider's growing awareness of the need to develop
increasingly effective systems of primary care that treat the whole person.
It is not necessary for each program to offer the full spectrum of needed
resources and services to successfully apply patient-matching techniques. Through
staff training and the use of carefully developed referral networks supported
by appropriate guidelines, staff can identify the need for additional services
and work with patients to offer them access to services that a single program
is unable to provide. Psychiatric, medical, and social work services are
the most commonly needed and used. Programs should place the highest priority
on obtaining resources or developing relationships with providers that can
provide these services in a convenient and cost-effective manner.
The remainder of this chapter provides a historical review of the development
of opioid substitution therapy and ongoing treatment issues. HIV/AIDS and
the concept of harm reduction are discussed, and additional comments about
the impact of managed care on the delivery of substitution therapy are reviewed.
When new treatments are developed, matching patients to these treatments can
be done relatively quickly. Clinicians in most medical settings readily accept
the concept of matching. There are numerous examples of this phenomenon.
For instance, clinicians began using a combination of drugs to treat HIV infection
when it was found that the HIV virus was able to quickly develop resistance
to AZT when it was used alone (Cheesman et al.,
1994).
However, in the case of opioid substitution therapy, the progression from the development
of a treatment for a very serious disorder to further treatment refinements,
including the use of matching strategies, has been delayed. For example, many single
State agencies have been slow to approve use of the opioid substitute levo-alpha-acetyl-methadol
(LAAM), even though its use reduces the risk of diversion. In addition, although
methadone has now been used for almost 30 years, patient-treatment matching strategies
have only just begun to be formally addressed in opioid substitution therapy
programs.
Reasons for this halting progression may be found in the historical development
of substitution therapy and in the ambivalence that has always surrounded
its use. Treatment of opioid dependence with substitution therapy has been
tried in isolated cases by individual practitioners and applied on a larger scale
as part of organized treatment programs for at least 100 years. Until the
advent of methadone maintenance in the 1960s, there was little or no scientific
evidence that opioid substitution therapy was generally helpful. Perhaps because
of this lack of evidence, reports of improper use, and diversion of legally
prescribed opioids, substitution therapy fell into public disrepute during the 1920s.
An administrative structure to control prescription and consumption of addictive
substances was put into place by the Harrison Act of 1914, which required dispensers
of opioids and cocaine to register annually, to pay a fee, and to use special
forms provided by the Internal Revenue Service. This move toward more controls
on addictive substances was consistent with the temperance movement and the
enactment of Prohibition in 1919. These structures to introduce controls over prescribing,
though seemingly modest in scope, were interpreted by law enforcement agencies
in increasingly restrictive ways beginning in the 1920s. As a result, the
few physicians who continued to prescribe opioids to addicted persons were
forced to discontinue this practice; to do so, even in the absence of diversion
or overt criminal behavior, became defined as an illegal act that could result
in suspension of a physician's medical license or even a prison sentence.
This movement toward strict limits on prescribing was greatly strengthened under
the leadership of Harry Anslinger, who was commissioner of the Federal Bureau
of Narcotics (FBN) from 1930 to 1964. (The FBN became the Drug Enforcement
Administration [DEA] in 1973.) Treatment became totally abstinence oriented, and two
Federal hospitals with long-term residential settings were established during the
1930s to treat opiate-addicted individuals. One hospital was at Lexington, Kentucky,
and the other at Fort Worth, Texas. Each hospital accepted voluntary patients
as well as prisoners who had been convicted of Federal crimes that were often
related to opiate dependence. Much of the early research on opioid dependence
was conducted in these settings, especially the Lexington facility. These
treatment facilities were very small and required patients to remain for long periods
in residential therapy. In addition, they were expensive, and although patients
improved, relapse rates were high after discharge from the residential setting.
In the early 1960s, Drs. Marie Nyswander and Vincent Dole became interested
in opioid addiction and relapse. They were aware of the problems that had
been associated with previous attempts at substitution therapy but did not give
up on the idea. They began to examine methadone as a possible solution.
This drug had been developed during World War II by Germany when its opiate
supplies were interrupted by the war. Methadone has all the pharmacological effects
of other opioids; however, it also has two properties which make it potentially
useful for substitution therapy: 1) It is well absorbed when given orally, and
2) it suppresses opioid withdrawal symptoms for 24 to 36 hours.
Thus, a single oral dose of methadone can prevent opiate withdrawal symptoms
for a day, while also avoiding the complications associated with parenteral
use. Using high doses of methadone for substitution therapy was found to produce
significant cross-tolerance to illicit opiate, thus diminishing the high produced by
heroin, which further contributed to methadone's efficacy. In addition, methadone
provides much more control over diversion or improper use, since a single daily
dose can be administered under direct observation.
Dole and Nyswander began a series of experiments in which they selected persons
with a long history of opioid dependence who were free of serious medical or
psychiatric problems and who were willing to participate in a study of methadone substitution
therapy (Dole and Nyswander, 1966;1967). Careful followup showed a significant change in the behavior that had
been typical of these patients. Illicit heroin use and criminal behavior were
markedly reduced, patients' sense of well-being and self-respect were significantly
improved, employment increased, and family problems were improved. In addition,
medical evaluations demonstrated no significant adverse effects as a consequence
of long-term maintenance (Kreek, 1973;1978;1983). On the basis of these early and very
positive results, methadone was approved in the early 1970s by the Food and Drug
Administration (FDA) as a substitution therapy for chronic opioid users who had demonstrated
an inability to achieve sustained abstinence.
Thus, after more than 50 years of public and legal opposition to substitution
therapy, a new drug, methadone, had been studied, applied, and found effective.
Within a period of several years, almost 100,000 opioid-addicted persons
were being treated with methadone in the United States. Methadone maintenance
became and remains the single treatment that is most acceptable to opiate-addicted
individuals.
This marked change in policy occurred rapidly and was not without its opponents,
especially among law enforcement agencies that had played a significant role in implementing
the earlier restrictive policies. Some medical professionals, particularly
those committed to long-term drug-free treatment, also opposed its use as did
some lay persons and politicians who felt that it represented "giving in" to
the problem or that it was another form of "slavery." These factors contributed
to a lack of public and professional acceptance of opioid substitution therapy.
In fact, attempts were made to arrest Dr. Dole, even after he reported
the very positive results that could be achieved by methadone maintenance treatment.
Since methadone can be abused like any other opioid, regulations were developed
by States, FDA, and DEA to limit and control its use. These regulations govern
who can administer methadone maintenance, eligibility for treatment, evaluation
procedures, dosages, take-home medications, frequency of patient visits, medical and
psychiatric services, counseling, support services, and related details. The various
regulations are complex, and State regulations are not always identical to FDA regulations.
For example, Federal regulations do not specify a limit on time in treatment;
however, some States and some programs set such limits. Similarly, some
States limit dosages of methadone to 80 mg a day or less, a lower limit than is
permitted by Federal regulations.
The FDA regulations were enacted in 1973 and revised in 1980 and 1989; they
have been described in detail in a previous TIP State Methadone Treatment
Guidelines. Copies of the most current FDA regulations are included in appendices
to that document.
The FDA has responsibility for approving programs and ensuring compliance with
FDA regulations; the DEA monitors the security of program facilities and compliance
with regulations concerning the handling of controlled substances. Programs
must also receive approval from the State methadone authority, which monitors
the same areas as the FDA and the DEA, and also serves as a source of technical
assistance. In addition, methadone treatment programs must meet other requirements
to be accredited by the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) and the Commission on Accreditation of Rehabilitation Facilities (CARF),
if they choose to be certified by these agencies.
The emphasis on regulatory compliance that has dominated opioid substitution
therapy programs since their inception has probably inhibited the development of
patient-treatment matching strategies. Although it is probably necessary to have a clinically
informed set of regulations that are reasonably enforced by qualified and well-trained
persons (characteristics that have not always been the case [Institute of Medicine, 1995]), the regulatory emphasis has consumed so much of
treatment providers' energy that it has in all likelihood diverted attention from
more clinically focused activities and impaired the development of clinically
focused approaches, such as matching strategies and treatment guidelines.
An emphasis on regulatory controls may have been necessary when opioid substitution
therapy was first developed. However, the relevance of a regulatory emphasis at
the present time is not so clear. For example, a recent report on methadone
by the Institute of Medicine concluded that the emphasis on regulations has
focused too much on protecting society from methadone and not enough on developing
methadone programs to best help persons with opioid dependence and to protect society
from the social disruption caused by heroin addiction (Institute of Medicine, 1995).
The potentially adverse effects of an overemphasis on regulatory control may
be strongest in the area of patient-treatment matching. The original patients
selected by Dole and Nyswander for substitution therapy were generally not polydrug
abusers; they were free of serious medical or psychiatric problems. After methadone
was approved for general use, a much more heterogeneous group of patients,
in particular those with serious psychiatric and medical problems, was admitted
to treatment. These patients did not progress as well as the original treatment
group (McLellan et al., 1983b).
The number of multiplicatively impaired patients has been growing, especially
since the AIDS epidemic. Patients with medical and psychiatric impairments are
those who can best be served by treatment matching strategies; they usually do
not progress unless these approaches are instituted. An emphasis on regulatory
compliance or overly restrictive interpretation of existing regulations can impair
the development of matching strategies and reduce the chances of good treatment
outcomes for patients with multiple problems.
LAAM is a long-acting opioid that can be used in place of methadone for opioid
substitution therapy. It was approved by the FDA in July 1994, after two decades of
study. Its effects are similar to those of methadone; that is, it creates a pharmacologic
cross-tolerance to heroin and other opioids and therefore blocks the euphoric effects of
those drugs while also controlling craving. LAAM can suppress the signs and
symptoms of opiate withdrawal for 48 to 72 hours, whereas methadone is effective
for 24 to 36 hours.
Use of LAAM allows patients to visit the clinic less frequently; instead of
daily visits for methadone, LAAM can be administered every other day from the
beginning of treatment. In addition, some patients report that they feel better
on LAAM than on methadone, perhaps because of LAAM's longer duration of action.
Some patients have reported a "smoother" effect, with fewer ups and downs.
LAAM is an alternative to methadone for opioid substitution therapy; it allows
the patient and clinician another choice. Although LAAM has been approved
by the FDA, it must also be approved by the individual State in which it is
to be used. As of this writing, approximately 20 States have approved the
use of LAAM, and it is being used in Portugal and several other European countries.
LAAM is discussed in detail in another TIP in this series, LAAM in the Treatment
of Opiate Addiction.
Since opioid substitution therapy became widespread, some important treatment
issues have come into focus. Several of these issues have a direct bearing on
the ability of programs to effectively carry out patient-treatment matching.
Two of the most important issues involve questions about the most effective
methadone dose and the optimal level of psychosocial services to provide in substitution
therapy programs. Other issues relate to the problems of polydrug abuse and to
choosing the best approaches for treating dually diagnosed patients, dispensing
take-home medications, and managing behavioral problems in the immediate vicinity
of the methadone clinic facility.
Several studies have been done to explore the issues of dose, psychosocial services,
and management of dually diagnosed patients. Studies of dose have shown conclusively
that, although some patients do well on 30 to 50 mg per day, those on higher
doses (60 mg per day or more) generally do better (Ball
and Ross, 1991). One of the best designed of these studies was done by
Ling and associates in the Veterans Administration
(Ling et al., 1976). It showed that patients randomly assigned to receive
100 mg of methadone a day did significantly better than those receiving 50
mg a day. The more positive effects of higher doses are probably mainly a
result of the significant levels of cross-tolerance that are obtained.
Other studies have addressed questions regarding the most appropriate levels
of psychosocial services and the treatment of dually diagnosed patients.
One of the most consistent findings of these studies is that there is no single
predictor of success for patients in treatment. Some have problems only with substance
abuse, while others have many problems, including psychiatric, legal, medical,
family-social, and employment problems. Studies have usually found that the provision
of more services is associated with better treatment outcomes. Studies that
have more closely examined interactions between services and outcomes have found
that patients are usually helped when services are targeted to specifically
identified problems (McLellan et al., 1993). For example,
studies have shown that professional psychotherapy given in addition to drug-focused
paraprofessional counseling can improve outcomes of patients with recurrent and coexisting
psychiatric symptoms (Woody et al., 1991).
Ambivalence about opioid substitution therapy continues in spite of the overwhelming
scientific evidence of its effectiveness. Many people are uncomfortable maintaining
patients on methadone for long periods, especially when maintenance may be indefinite.
Some of the controversial issues focus on very real problems such as how
best to treat methadone-maintained patients who abuse or are dependent on other
drugs. Some programs want to withdraw from methadone those patients who have
other AOD problems or serious medical or psychiatric problems. Use of cocaine,
benzodiazepines, and alcohol has presented special difficulties, since administration of
methadone does not directly address the use of these substances. Evidence is accumulating,
however, that the psychosocial and behavioral aspects of methadone treatment programs
are often helpful in suppressing nonopioid drug abuse (Arndt, 1992;McLellan et al. 1993) however,
psychosocial treatments alone leave much room for improvement.
Other issues sometimes focus on the goals of methadone treatment. Should methadone
maintenance be a stepping stone to eventual abstinence, or is it an acceptable lifelong
treatment? From the data, one could argue that it is an acceptable lifelong treatment
for many patients but that some can achieve long-term and stable drug-free
adjustment. Who are these patients, and how are they best identified? These questions
need further research.
A current and important issue, and one on which little research data are
available, is how to decide that methadone treatment either is appropriate for a patient
or is not working. Studies indicate that overall drug use by most methadone
patients is markedly reduced, even though total abstinence may not be achieved.
Although the goal of most treatment providers is to maintain patients on
methadone in the absence of illicit drug use, this goal is often not achieved. At
what level of drug use does one conclude that methadone maintenance is not helping
and another treatment should be tried, even to the point of terminating methadone
treatment against the patient's wishes?
Decisions in this area have always been difficult, but they have become even more
complex with the advent of HIV infection. As discussed later in this chapter,
data are accumulating showing that opioid-addicted persons who are maintained
on methadone have a substantially reduced chance of becoming infected with
HIV, even though they might not completely stop illicit drug use (Metzger et al., 1993). At what point can it be said that enough harm reduction
has occurred to justify continued methadone maintenance despite the fact that
the patient's progress is not at the expected level? More data are needed
to guide decisions in this area. Available data indicate that substantial
risk reduction can occur without the achievement of total abstinence. However,
patients who continue to use drugs may erode clinic morale as other patients come
to the conclusion that compliance and abstinence are not expected.
In summary, although many important issues remain, the data strongly indicate
that opioid substitution therapy can provide substantial benefits to persons
with opioid dependence. This important point should not be obscured in our
attempts to identify problems and improve upon methadone treatment, to find newer
substitution therapies that may be more efficacious for some patients than methadone,
such as LAAM, and to develop guidelines and strategies for treating addicted
patients with opioid substitution therapy.
As discussed earlier, there is growing evidence that involvement in opioid
substitution therapy reduces the risk of HIV infection, even if illicit drug use is
not completely eliminated. In addition, HIV-positive patients who are receiving
substitution therapy are engaged in a treatment program in which they are seen frequently.
Their engagement in treatment generally allows them better access to important
medical services than they might otherwise have (provided the services are available).
Engaging this patient population in continued care has significant public
health implications. Not only can these patients receive treatment for HIV disease
and its complications, but they also can receive counseling about the disease
and about behavioral changes that will reduce the risk of HIV transmission.
A prime example of a public health benefit that can be achieved by effectively
run opioid substitution therapy programs is screening for tuberculosis (TB),
which has increased significantly in recent years, especially in association
with HIV disease. The medical evaluations that occur at intake to substitution
therapy programs provide an opportunity to identify patients who carry TB or have
active TB. One of the difficulties of treating TB is that many persons fail to
comply with medication regimens and must be carefully monitored. The frequent
clinic visits that are part of opioid substitution therapy provide an opportunity
for direct observation of antituberculosis pharmacotherapy.
A more recent harm reduction intervention is interim substitution therapy.
This treatment involves daily administration of methadone without provision
of regular counseling services. It is applicable only on a time-limited basis
and only when there are waiting lists for methadone programs. The aim of interim
therapy is to provide some reduction in opiate use while a patient is waiting for
a place to open in a more fully staffed treatment program. Interim treatment
has been found to decrease the use of heroin and other opioids; however, patients
who participate in programs in which more comprehensive services are available
achieve greater reductions in use (Yancovitz et al.,
1991;McLellan, 1993).
Concerns about interim therapy have been raised, especially if it is seen by providers
and managed care companies as a less expensive and equally effective model
for the treatment of opiate dependence. Interim therapy should never be viewed
as an alternative to comprehensive opioid substitution therapy programs.
Meeting patients' needs in opioid substitution therapy cannot be addressed without
looking at the cost benefits of providing comprehensive services to opioid-dependent
patients. These are often persons with no readily available entry point into the
healthcare system, and methadone treatment programs often provide an entry. Therefore,
appropriate decisions about what services are needed, for how long, and in what setting
are crucial. As described above, untreated addicted patients meet their healthcare
needs in a crisis-oriented episodic fashion -- by utilizing emergency services
as their primary care provider. Implementation of comprehensive outpatient
models providing long-term care decreases the high utilization of more expensive
acute care services.
Many programs are not able to afford comprehensive services for patients entering
opioid substitution therapy. Therefore, programs must develop other models for
effective services. One option is to develop linkages or networks between services
and to refer patients to offsite services, thus attempting to contain costs
while providing necessary services. Unfortunately, because of the fragmented
system of publicly funded healthcare, public ambivalence about treating persons
with opioid dependence, and extremely restricted resources in the public outpatient
treatment area, many programs have great difficulty or even find it impossible to
establish these liaisons. In these cases, programs must do the best they can and
hope for improvements in service delivery that will make meaningful, comprehensive
treatment possible.
As discussed earlier in this chapter, the potential financial advantages to
managed care companies from combining psychiatric and medical services with substance
abuse treatment may change this situation. Treatment providers and taxpayers
could benefit from serious efforts to combine these important services and realize
the cost savings that may result.
Recent Federal block grant requirements have created a mandatory link between
the provision of substance abuse treatment and other healthcare services for
pregnant and parenting women, persons from minority groups, individuals with dual
diagnoses, injection drug users, disabled persons, HIV-infected persons, and persons
with TB. While not designed specifically for opioid substitution therapy, these
requirements must be met by all programs receiving Federal funding under the State block
grant mechanisms. Now being implemented, the regulations are particularly important
for State AOD directors who must determine how to establish the mandated links.
These requirements may encourage States, HMOs, managed care companies,
and other healthcare providers to increase their efforts to develop the treatment
resources that will make matching strategies more of a reality than they are at present.
Many of these aims can be achieved through networking.
Effective networking should cut across several disciplines. Some examples of networking
are described below:
Contact with State and city public health, mental health, and vocational rehabilitation
departments.
Creation of ad hoc alliances. For example, under the Yale/New Haven Model, a methadone
treatment program became allied with the mayor's task force to create a women's health
consortium. The consortium established a referral network through which each client
had two counselors, one for methadone treatment and one for other health, mental
health, and ancillary needs.
Access to services supported by the Federal Government, including clearinghouses,
electronic databases, and training and technical assistance programs.
Access to programs for special populations, including abused children, victims
of domestic violence, the homeless, and persons with disabilities.
Use of pro bono legal services.
Establishment of relationships with health, mental health, and civil rights advocacy
groups.
Use of educational, training, and technical assistance resources available
through professional organizations.
Equally important is the development of a proactive attitude toward community outreach.
For example, program staff might seek opportunities to sit on the boards
of directors of other agencies and organizations, and members of these organizations
might be invited to join the opioid substitution program board. Such relationships
broaden understanding of individual and shared program goals and increase the likelihood
of appropriate referrals. Given the multiplicity of patient needs and limited
resources, "turfism" and insularity are ill advised.
In addition to providing concrete services, networking can create a feeling
of shared responsibility for patient welfare. It also increases program visibility
and broadens public understanding of the purpose of opioid substitution therapy
and its role in substance abuse treatment and rehabilitation.
Persons who are addicted to opioids share many of the problems and needs of those
with other substance use disorders. At the same time, opioid-addicted persons
present unique treatment challenges. The CSAT consensus panel believes that the
following five challenges are especially important.
Among the most important factors to be understood when assessing the progress
of an opioid-addicted patient is the probability of relapse, or recurrence
of opioid use. Posttreatment followup studies have shown that roughly 80
percent of all patients resume daily use of opioids within the first year of leaving
treatment (Ball and Ross, 1991;Hubbard and Marsden, 1986;Simpson and Marsh, 1986). However, it has also been shown that relapses may lead to a series of
readmissions that are eventually associated with successive reductions in drug use and
even extended periods of remission (Simpson and Savage,
1980). A 12-year followup study of 490 opioid-addicted patients treated in the
Drug Abuse Reporting Program showed that each patient averaged more than six
AOD treatment admissions. However, improvement occurred over time, and only
one patient in four was still using opiates in the year preceding the last
followup interview (Marsh et al., 1990).
Even patients who are highly motivated to achieve total abstinence and who terminate
treatment under the best of circumstances have a less than 50 percent chance of remaining
in full remission for as long as 3 years (Hargreaves,
1983). Such surveys substantiate the General Accounting Office conclusion that
heroin addiction is a chronic, relapsing condition that many persons "will battle
the rest of their lives" (General Accounting Office,
1990).
Relapses are, in other words, a predictable part of opioid addiction. The number
of relapses does not predict failure in treatment; in fact, past relapses
correlate positively with ultimate treatment success, and resistance to relapse increases
as long-term abstinence increases (Simpson and Marsh,
1986).
Studies that explore additional predictors of treatment outcome have shown that
patients who are older, have a stable family and an intact marriage, and are employed
are more likely to have positive results than younger, unemployed patients
with less stable family support.
Polydrug and alcohol abuse, psychopathology, and a history of criminal activity
that is independent of the substance use disorder are associated with poorer
treatment outcomes (Anglin and Hser, 1990;McLellan, 1986).
Substitution therapy often has been mistakenly perceived as a simple and inexpensive
pharmacologic treatment for opioid addiction. On the contrary, most patients who enter
opioid substitution therapy have multiple needs and the most effective programs
provide comprehensive services to meet these needs (Anglin
and Hser, 1990;Ball and Ross, 1991;Joe et al., 1991). One recent study has shown that 85 percent of patients
entering methadone treatment had problems in more than one of the following areas:
physical or mental health; family and peer relationships; and legal, educational,
vocational, and financial matters.
Although most patients' needs were in more than one of these areas, only 25 percent
reported receiving any medical, psychiatric, or social services during the critical
first month of treatment (Condelli, 1993). The
role of ancillary services in improving treatment outcome is illustrated in
studies such as that of McLellan et al. (1993), who
documented an improvement in AOD treatment outcomes associated with provision of appropriate
psychosocial services to methadone patients. As discussed in later chapters of this
TIP, some patients require assistance in gaining access to and utilizing needed
services. An addictions counselor or case manager often performs this function.
Retention is thus a primary objective of treatment, and the challenge to the clinical
team is to take every reasonable action to keep the patient actively engaged.
Several investigators have sought to determine the factors most likely
to be associated with retention. Among these are comprehensive and individualized
services, caring staff, "user friendly" program protocols, and an adequate methadone
dosage (Condelli, 1993;Joe et al., 1991).
To promote retention, patients should be engaged in treatment and participate
actively in the therapeutic process. More frequent attendance, compliance with
psychiatric services, and use of other ancillary services are associated with improved
treatment outcomes (McLellan et al., 1993;Simpson et al., 1995). Thus, augmenting program resources and encouraging
their use should be prime concerns of program staff. One recent study found
that elimination of treatment fees increased retention during the first year
of treatment (Maddux et al., 1994). Consideration
also should be given to developing techniques for monitoring service delivery
and levels of patient engagement over time (see Chapter
5 on program evaluation). As is discussed later in this TIP, case managers
can play an important role in retaining patients in treatment by ensuring that
they gain access to and use needed services.
Recent research has deepened understanding of the contribution of patient motivation
and readiness for change to positive outcome in persons with AOD disorders
(Miller and Rollnick, 1991;Prochaska and DiClemente, 1986). For this reason, it is important to explore
patient motivation at the time of assessment and throughout treatment. Most patients
are initially ambivalent about treatment, and clinicians must help them resolve
this ambivalence. Many patients may have attitudes or experiences that create
obstacles to engaging in treatment. For example, some patients have the fixed notion
that only methadone will work for them and that methadone is all they need.
Others may not want to participate in 12-step programs because of negative
past experiences with persons in those programs who rejected opioid substitution
therapy. Some patients may resist medical care because healthcare providers in
the past have reacted negatively to their addiction and its associated behavior.
Clinicians must be prepared to identify and overcome these obstacles. They also must
be prepared to clarify and negotiate mutually acceptable treatment goals.
The more committed patients are to their treatment goals, the more likely
they are to remain in the program and have a positive outcome (Simpson and Joe, 1993).
Patient noncompliance -- whether it manifests as a deviation from an individual
treatment plan or as a violation of program rules -- should be seen not only as a
sign of potentially poor outcome, but also as an indication of possible problems
in the treatment plan. Providers should continually review and examine their
delivery of services before "blaming" the patient for not complying with treatment.
Program staff must be alert to subtle attitudinal changes of patients
and be prepared to address those attitudes even before problems stemming from
noncompliance arise and interfere with treatment. The reasons underlying a loss of motivation
or ambivalence about treatment goals should be promptly explored and resolved,
if possible, with the objective of making the treatment plan more realistic.
For example, a patient's response to a brief relapse to opioid use could
lead to discouragement and premature termination if the staff did not encourage
and educate the patient about the realistic course of addiction treatment.
Clinicians who provide opioid substitution therapy must create opportunities to educate
the community, including the public, legislators, and third-party payers, about
the nature of opiate addiction, its anticipated outcomes, and the benefits
of treatment. Methadone is commonly seen as a "chemical crutch," and opioid
substitution therapy is viewed as replacing one drug with another. Added to such philosophical
and ideological reservations may be fears of public and personal safety stemming
from drug sales or clients' loitering in neighborhoods where opioid substitution
therapy programs are located.
Treatment program staff must make efforts to overcome misconceptions concerning opioid
addiction and inform the public about the entire range of treatment options and the
overall positive benefits of opioid substitution therapy. They can do this through
networking, public education (giving examples of patients who were helped by substitution
therapy), and outreach.
This TIP provides guidelines for meeting patient needs in opioid substitution
therapy. It takes into consideration the needs of patients, limited resources,
the current knowledge base, and outcome evaluation.
Chapter 2Assessing Patient Needs provides
a brief overview of opioid substitution therapy and definitions of terms
used in the TIP. Guidelines are offered for conducting both a preliminary assessment
to determine a person's appropriateness for substitution therapy and a comprehensive
biopsychosocial assessment upon entry into the program. Areas to assess are recommended,
including the patient's expectations and motivation. Effective matching depends
on careful ongoing assessment, which is also discussed.
Chapter 3Phases of Treatment proposes a six-phase
model of opioid substitution therapy that includes the acute and rehabilitation
phases, the supportive care phase, medical maintenance, tapering and readjustment,
and aftercare. Patient needs characteristic of each phase are described, and
strategies for meeting these needs are outlined. Clinical indicators for transition
into other treatment phases are described.
Chapter 4Treatment Elements looks at core
services essential for opioid substitution therapy programs and the responsibilities
of staff from various disciplines who facilitate the use of treatment matching
strategies in these programs. Common comorbid medical and psychiatric disorders are
discussed and the roles of counseling and psychotherapy are summarized. Special
considerations, such as childcare and access for disabled persons, are addressed.
Chapter 5 Self-Monitoring and Evaluation addresses
the importance of program self-monitoring and evaluation of treatment outcomes.
Goals of these processes are outlined, and a step-by-step guide for conducting
self-monitoring and evaluation is presented. A detailed hypothetical example is included
in an easy-to-follow chart format that lays out the evaluation steps described
in the text.
Chapter 6Cost-Effectiveness of Opioid Substitution
Therapy addresses the costs of opioid substitution therapy services and describes
approaches to calculating treatment costs.
Appendix A, lists references cited in the text,
as well as other useful articles. Appendix B contains
the Massachusetts Methadone Treatment Criteria, which were modeled on the American
Society of Addiction Medicine patient placement criteria (American Society of Addiction Medicine, 1991). They provide admission, continuing
care, and discharge criteria for AOD abuse treatment including methadone substitution
therapy. For readers who are interested in designing and conducting research on
the costs of AOD treatment, Appendix C presents
several methodological approaches to consider. Appendix
D is a list of the Federal resource panel members who contributed suggestions
during the initial phases of the development of this TIP. Appendix E is a list of experts who participated in the field review of the
TIP.
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