Best Practices - Methadone Maintenance Treatment

2. Background

2.1 What is Substance Dependence?

According to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)⁵, the key feature of substance dependence is "a cluster of cognitive, behavioural and physiological symptoms indicating that the individual continues use of the substance despite significant substance-related problems...a pattern of repeated self-administration that usually results in tolerance, withdrawal, and compulsive drug-taking behavior." Although tolerance and withdrawal are usual features of substance dependence, the DSM-IV notes that neither is necessary for a diagnosis of substance dependence (Brands and Brands, 1998, 42).

As Brands et al. (1998, 43-44) explain, the term "addiction" is no longer widespread in the medical community, and has been largely replaced by the term "drug [or substance] dependence." They also note that the term "drug [or substance] abuse" is: "a highly complex, value-laden and often excessively vague term that does not lend itself completely to any single definition." Furthermore, because the term has different meanings for different groups of people - and their definition of the term reflects their different perspectives - there is often difficulty in drawing a line between use of substances and abuse of substances (Brands et al., 1998, 45).

2.2 What is Opioid Dependence?

According to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), (reprinted with permission from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Copyright 1994 American Psychiatric Association), opioid dependence is a substance dependence disorder. The DSM-IV specifies criteria for opioid dependence (which are the same as for substance dependence) and which include physical tolerance of, and dependence on, opioids, as well as the compulsive use of opioids despite harm:

"A maladaptive pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12-month period:

1. tolerance, as defined by either of the following:
   1. a need for markedly increased amounts of the substance to achieve intoxication or desired effect
   2. markedly diminished effect with continued use of the same amount of the substance
      
      
2. withdrawal, as manifested by either of the following:
   1. the characteristic withdrawal syndrome for the substance (refer to criteria A and B of the criteria sets for Withdrawal from the specific substances)
   2. the same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms
      
      
3. the substance is often taken in larger amounts or over a longer period than was intended.
4. there is a persistent desire or unsuccessful efforts to cut down or control substance use
5. a great deal of time is spent in activities necessary to obtain the substance (e.g., visiting multiple doctors or driving long distances), use the substance (e.g., chain-smoking), or recover from its effects
6. important social, occupational, or recreational activities are given up or reduced because of substance use
7. the substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance (e.g., current cocaine use despite recognition of cocaine-induced depression, or continued drinking despite recognition that an ulcer was made worse by alcohol consumption)..."

2.3 Impact of Opioid Dependence

People who are dependent on opioids often lead extremely stressful and chaotic lives, and frequently experience serious health and social problems as a result of their dependence. They are at high risk for premature death from accidental drug overdose, drug-related accidents and violence. Sharing needles, syringes, straws, cookers or other contaminated drug-taking equipment, for example, places them at high risk of acquiring human immunodeficiency virus (HIV), hepatitis C virus (HCV) or other blood-borne pathogens. The problem of opioid dependence may be exacerbated by multiple substance use, as well as by factors such as poverty, and homelessness. Mental health disorders - such as depression, antisocial personality disorder and phobias - are common. Often, people who are dependent on opioids have experienced a long history of rejection, exclusion, and incarceration, which reinforces their sense of alienation and antagonism. They may have little sense of control over their lives.

Opioid dependence is a costly social problem. Researchers have estimated that there may be 40,000 to 90,000 people in Canada who regularly use heroin (Fischer and Rehm, 1997, 367). The majority of people who are dependent on opioids are injection drug users.⁶ Untreated, opioid dependence involves costs related to criminal activity, medical care, drug treatment, lost productivity, and, increasingly, transmission of HIV, HCV and other blood-borne pathogens. In 1996, approximately half of the estimated 4,200 new HIV infections that occurred in Canada were among injection drug users (IDUs) (Health Canada, 1999b, 1).⁷ According to the Laboratory Centre for Disease Control (as cited in Health Canada, 2000a, 6), at least 70% of prevalent HCV infections are related to injection drug use. Some populations of individuals who are dependent on opioids are particularly vulnerable to the dual problem of injection drug use and infection with HIV, HCV or other blood-borne pathogens including women, street youth, offenders in correctional facilities, and Aboriginal people (Canadian HIV/AIDS Legal Network, 1999, 11; Health Canada, 2000a, 15-20).

Research by Single et al. (as cited in Fischer and Rehm, 1997, 368) indicates that the costs related to injection drug use and opioid dependence are significant. Overall, illicit drug use cost an estimated $1.37 billion in Canada in 1992, and about 70% of this (or $48 per capita) was attributed to opiate use. The lifetime (i.e. over a 17-year period) costs of treating an individual with HIV infection are estimated at $153,000 (Albert and Williams, 1998, 38).

2.4 What is Methadone Maintenance Treatment?

Although other forms of treatment for opioid dependence continue to be explored, in Canada and internationally, methadone maintenance treatment remains the most widely used form of treatment for people who are dependent on opioids. Methadone itself is a long-acting synthetic opioid agonist, which is prescribed as a treatment for opioid dependence. People who are dependent on opioids may be dependent on either oral or injectable forms of opioids such as heroin (diacetylmorphine), morphine or hydromorphone. Methadone maintenance treatment is an appropriate form of treatment for opioid dependence, regardless of the route of administration (oral or injection).

There is no universal definition of what a methadone maintenance treatment "program" is, although the common basis is clearly the use of methadone. Program components and policies vary widely around the world, and within Canada. A comprehensive approach to methadone maintenance treatment, however, generally includes a number of components - which can be delivered in a variety of ways and at varying levels of intensity - including:

• methadone dose;
• medical care;
• treatment for other substance use;
• counselling and support;
• mental health services;
• health promotion, disease prevention and education;
• linkages with other community-based supports and services; and
• outreach and advocacy. (See Section 4.6: Integrated, Comprehensive Services).

2.5 How does Methadone Work?

Methadone works by alleviating the symptoms of opioid withdrawal. A stable and sufficient blood level of methadone stems the chronic craving for opioids. Since methadone is a much longer acting drug than some other opioids, such as heroin, one oral dose daily prevents the onset of opioid withdrawal symptoms - including anxiety, restlessness, runny nose, tearing, nausea and vomiting - for 24 hours or longer.

Methadone diminishes the euphoric effects of other opioids (cross tolerance), without necessarily causing euphoria, sedation or analgesia (Lowinson et al.,1997, 407). This means self-administered illicit opioids will not lead to euphoria, making it less likely that clients/patients will either use illicit opioids or overdose.

Individuals in a methadone maintenance treatment program take their medication orally once daily - often it is mixed into an orange drink. Since methadone is long-acting, the need to inject other opioids is decreased and this reduces the health risks associated with injection drug use.

Tolerance to the effects of methadone develops very slowly, allowing many individuals who are dependent on opioids to be maintained on the same dose of methadone safely for many years.

When appropriately prescribed and dispensed, methadone is considered a medically safe medication.

For further information on the pharmacology and pharmacokinetics of methadone, readers are encouraged to consult the references cited in the back of this document.

2.6 Brief History of Methadone Maintenance Treatment

Methadone was originally developed in Germany as a substitute analgesic for morphine. World War II brought the formula to the attention of North American researchers, who subsequently discovered that methadone could be used to treat heroin withdrawal symptoms. Although the work of American researchers, Dole and Nyswander, in the early 1960s is perhaps best known for demonstrating that methadone was suitable as a maintenance treatment, a Canadian researcher, Dr. Robert Halliday, set up what may have been the first methadone maintenance treatment program in the world in British Columbia in 1963 (Ruel, as cited in Health Canada, 1998, 3; Berger, Carlisle and Marsh, as cited in Ontario Ministry of Health, 1999, 6).

To date, methadone remains the only opioid authorized for long-term (more than 180 days) outpatient pharmacological treatment of people who are dependent on opioids in Canada (Health and Welfare Canada, 1992, 10). In the almost forty years since methadone was first used in Canada, the number of people receiving treatment has fluctuated, as the regulations surrounding methadone have changed. After national guidelines for prescribing methadone were first introduced in 1972, the number of people receiving treatment dropped from 1,700 in 1972 to only 600 in 1982 (Berger, Carlisle and Marsh, as cited in Ontario Ministry of Health, 1999, 5). Since then - as awareness and concern about opioid dependence and related public health risks, notably the increasing rate of infection with HIV, HCV and other blood-borne pathogens among injection drug users has grown - the number of people who are dependent on opioids who are receiving methadone maintenance treatment has increased.

2.7 Evolving Regulatory and Administrative Context

The regulatory and administrative context within which methadone maintenance treatment in Canada is delivered continues to evolve. From the mid-1990s to the present, there have been significant changes in the administration of methadone maintenance treatment. The Office of Controlled Substances, Health Canada, permits physicians to prescribe methadone. In recent years, the provinces have begun to take over some responsibilities for administering methadone maintenance treatment programs. At this time, several provinces have developed - or are in the process of developing - guidelines and training for practitioners interested in providing methadone maintenance treatment.

2.8 Increasing Access to Methadone Maintenance Treatment in Canada: Overcoming Barriers

Current efforts to increase access to methadone maintenance treatment are linked to continued concerns about the relatively low numbers of people who have access to methadone maintenance treatment in Canada, as compared to other countries, such as Australia, that have emphasized methadone maintenance treatment as a key strategy for public health.⁸ Although in recent years, the number of clients/patients enrolled in methadone maintenance treatment has increased to approximately 15,000 (D. Marsh, personal communication, November 2000), critics of the situation in Canada still note that there are still barriers at every level - within society, in systems, in programs, and at the individual level - that need to be addressed.

To date, some of the signs of progress in overcoming barriers include:

• a growing awareness in the field that ongoing dialogue - at all levels - as well as a commitment to collaboration and coordination will be needed to overcome barriers and increase access to methadone maintenance treatment in Canada;
• an increased recognition among practitioners of the need for flexible and individualized services, driven by client/patient needs;
• an increasing emphasis in the field on the role of methadone maintenance treatment programs within a harm reduction⁹ approach to opioid dependence (Fischer and Rehm, 1997, 369); and
• international recognition of methadone maintenance treatment - particularly low threshold approaches to treatment - as an important strategy to combat transmission of HIV - and to potentially help prevent and control the transmission of HCV and other blood-borne pathogens - among injection drug users.

Suggestions for increasing the accessibility of methadone maintenance treatment, particularly within programs and for specific groups of people, are included throughout this document.

Barriers	Potential Ways to Address Barriers
Attitudinal barriers to treatment including fear and misinformation	Expand educational efforts - including dissemination of information - among policymakers, practitioners, public and clients/patients
Philosophical differences among practitioners	Educate and provide opportunities for dialogue
Insufficient resources for treatment	Increase resources and/or reallocate existing resources
Lack of practitioners	Link educational strategies with recruitment initiatives. Explore incentives
Level of regulation	Ongoing dialogue and consultation with all jurisdictions to clarify roles
Uneven or fragmented access to services across jurisdictions and sectors and lack of transferability	Ongoing interjurisdictional and intersectoral dialogue and information sharing to "cross-fertilize" knowledge and experience of best practices
Lack of access in rural or remote areas	Increase access - see Section 7.7 - MMT and People Living in Rural and Remote Areas
Lack of outreach	Increase outreach - see Section 4.6.7 -Outreach and Advocacy
Program Policies (admission criteria, etc.)	Revisit program policies - see Section 5.0 -Best Practices in MMT - Program Policies
Lack of supports for clients/patients (costs of treatment, access to and cost of transportation, access to and cost of child care, etc.)	Increase supports for all clients/patients including those with specific needs - see Section 7.0 - Best Practices in MMT -Meeting the Needs of Specific Groups.
Lack of supports for team members	Increase supports for practitioners - see Section 6.0 - Best Practices in MMT -Program Team and Environment

2.9 What is the Status Quo - How is Methadone Maintenance Treatment Delivered in Canada and Internationally?

Around the world, methadone maintenance treatment is delivered in many different ways. In addition to differences in national regulatory frameworks, programs differ widely in terms of their philosophy, the extent of non-pharmacologic treatment services provided, their program policies, and program settings. Programs also serve different client/patient groups.

In some countries, efforts are being made to increase access to methadone maintenance treatment. In the United States, for example, attempts to increase access to methadone maintenance treatment have led to new approaches to program delivery, such as:

• "medical maintenance" (based in physicians' offices);
• "limited service" programs (methadone alone, without comprehensive services);
• methadone clinics as primary-care sites (on-site access to primary health care services);
• residential short-stay methadone treatment;
• corrections-based programs;
• special primary medical care services for people living with HIV/AIDS;
• culturally sensitive, family-centred treatment; and
• programs that "frontload" services to newly admitted clients/patients (Lowinson et al., 1997, 412-413).

Other countries have also introduced a range of different program delivery approaches - well-known examples include strategies such as the mobile vans in the Netherlands and Boston (Lowinson et al., 1997, 413).

Methadone Maintenance Treatment in Canada

In Canada, as in many other countries, there is a national level regulatory framework for methadone prescription. The Office of Controlled Substances, Health Canada, works with provincial/territorial governments and medical licensing bodies to facilitate increased access to methadone maintenance treatment. To date, several provinces have developed - or are in the process of developing - guidelines and training for practitioners interested in providing methadone maintenance treatment. Although provinces have become increasingly involved in delineating the conditions under which physicians are permitted to prescribe methadone, methadone can be prescribed only by physicians who have received an exemption under the Controlled Drugs and Substances Act.

There is a dearth of published information about the various types of programs available in Canada. A national survey of substance use treatment programs collected information on 870 programs (estimated to be about 70% of the programs available in Canada). A total of 38 programs reported that they provide methadone maintenance treatment, and about half of those report using a higher dose regimen (60-100 mg/day). The prevalence of, and perceived need for, such treatment varies across the country (Health Canada, 1999c, 1,17,20).¹⁰ According to a recent national report, many methadone maintenance treatment programs in Canada adhere to an abstinence philosophy, and some do not offer comprehensive services such as primary health care, counseling or education. Furthermore, while some provinces have expanded their methadone programs and made them more accessible, other provinces do not have any methadone programs (Canadian HIV/AIDS Legal Network, 1999, 6,16).

The research for this document, including a search of the Canadian Centre on Substance Abuse Treatment database, suggests that methadone maintenance treatment programs are delivered in a range of different settings including:

• substance use treatment services/clinics (outpatient/inpatient);
• community-based health centres/clinics;
• private medical clinics;
• individual physicians' offices (linked with community-based pharmacies);
• hospital-based health clinics;
• HIV/AIDS services/clinics;
• mental health agencies/clinics; and
• correctional facilities.¹¹

Those who are involved in treatment delivery include practitioners and service providers from many different disciplines and backgrounds including medicine, psychology, substance use treatment and rehabilitation, social work, mental health and others. Practitioners' roles in providing treatment tend to vary somewhat depending on a variety of factors including program setting, available resources and geographic location. There also appears to be a significant amount of diversity across jurisdictions and among programs - in terms of program philosophy, range of services provided, client/patient groups served, level of client/patient involvement, program policies, and program settings.

2.10 What Types of MMT Programs are Most Effective?

At this time, as Bell (1998a, 161) points out, "despite an extensive research literature, there is no broad consensus on the role of methadone maintenance treatment, or on how treatment should be delivered. Even where there is firm empirical evidence, such as the importance of adequate methadone dose, treatment practices are often out of line with research evidence." Some of the difficulties in developing consensus on the most effective treatment approaches relate to the diversity of treatment goals. Other problems stem from the fact that some types of programs have been extensively evaluated, while others have received less attention. Furthermore, the current constellation of different delivery strategies represent attempts to respond to specific needs or circumstances.

There is evidence, however, that suggests that there are some "cross-cutting" features or characteristics of programs that increase the likelihood of client/patient retention and enhance other outcomes. Retention is a particularly key outcome - if programs cannot recruit and retain clients/patients, the potential benefits of treatment will not be realized. Consequently, this manual focuses on key aspects of:

• program development and design;
• program policies;
• program team and environment; and
• tailoring of programs to meet the needs of specific groups of clients/patients.

Insights from the field

• Practitioners (and clients/patients) need access to a database of all the programs available across the country.
• Different service delivery communities need ways to share their knowledge and experiences.
• It is important to clarify the treatment goals against which program effectiveness will be evaluated.
• There is a need for a continuum of program options, e.g. low threshold programs may serve as a "bridge" to programs with more comprehensive services.

Best Practices in MMT

Program Development and Design

• Clear program philosophy and treatment goals
• Focus on engagement and retention
• Maintenance orientation
• Client/patient-centre d approach
• Accessibility
• Integrated comprehensive services
  • Medical care
  • Other substance use treatment
  • Counselling and support
  • Mental health services
  • Health promotion, disease prevention and education
  • Linkages with other community-based services and supports
  • Outreach and advocacy
• Client/patient involvement
• Involvement of wider community
• Adequate resources

Program Policies

• Open admission
• timely assessment
• Adequate individual dosage
• Methadone dosage during pregnancy
• Unlimited duration
• Clear criteria for discharge
• Non-punitive approach to other drug use during treatment
• client/patient - Centred management of withdrawal

Delivery Modes

• Continuum of program delivery to meet needs of different people at different stages of treatment

Program Staff and Environment

• Multidisciplinary program team
• Adequate human resources
• Competence, attitudes, behaviours
• Relationships and support
• Adequate ongoing training
• Program environment
• Organized structured approach
• Safety
• Flexible routines
• Information collection and sharing

Meeting the Needs of Specific Groups

• People with multiple substance use disorders
• People who are dependent on oral opioids
• Women
• Pregnant women
• Infants
• Youth
• People who are homeless
• People living in rural or remote communities
• First Nations and Inuit
• People living with HCV
• People living with HIV/AIDS
• People with mental health disorders
• Offenders in correctional facilities

Research and Evaluation

• Address research gaps
• Evaluate programs

2.11 Developing a Continuum of MMT Program Delivery

Given the diversity of clients/patients' goals and needs, the availability of a continuum of different types of program delivery modes - from "limited service"¹² to much more intensive levels of services - may be the most important concern. There should be recognition that people who are dependent on opioids are a heterogenous population with diverse reasons for entering (or not entering) treatment. They do not all have the same type or level of need for treatment. Finally, as in all types of treatment, most people's needs will change over time, as treatment progresses. The more flexible, innovative and collaborative are the responses of various treatment delivery communities - including physicians, substance use treatment providers, and others - the better.

Insights from the field

• Increase the number of program options and expand the points of access.
• Increase the level of outreach, particularly for people who are homeless or who have concurrent mental health disorders.
• Make more low threshold programs available, and ensure they have linkages with more comprehensive programs.
• All hospitals should have the capacity (and trained staff) to provide MMT.
• All substance use treatment facilities should have policies and procedures in place to accept MMT clients/patients.
• Ensure community pharmacists are designated as members of the program team.
• Link substance use treatment and mental health treatment services.
• Recruit (and support ) more family physicians to obtain authorization to prescribe methadone and become involved in shared care with community based agencies and facilities.
• Encourage a multidisciplinary approach to program delivery.
• Involve trained nurse-practitioners in program delivery.
• Develop more community-based clinics in accessible locations.
• Rely on family physicians to provide ongoing care for stabilized clients/patients who have little need for intensive services (with linkages to other services when needed).
• Attending a physician's office, rather than a specialized clinic, may be less stigmatizing for clients/patients.
• Have prescribing physicians working in needle exchange centres.
• Explore international models, eg. automated dispensing.

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