Matching Treatment to Patient Needs in Opioid Substitution Therapy
Treatment Improvement Protocol (TIP) Series 20

Physicians

All opioid substitution programs are required by Federal and State regulations to have a physician who is identified as the program's medical director. The physician may be a psychiatrist or internist, must be either onsite or on staff as an employee or consultant, and must be registered to prescribe and administer methadone or levo-alpha-acetyl-methadol (LAAM) for opioid substitution therapy. The medical director may be assisted by one or more additional physicians, who must also be registered with the State and the FDA and approved by the Drug Enforcement Administration (DEA). The medical director is responsible for the overall substance abuse, medical, and psychiatric treatment of patients in the program. For some patients who need many services, compliance may be improved if the program physician can spend sufficient time with the patient to establish a strong physician-patient relationship.

In some programs with greater resources, physicians can play a more integrated and specialized role in ongoing treatment. For example, a program physician trained in internal medicine may take a more active role in diagnosing and treating medical disorders. If the medical director is a psychiatrist, he or she can provide onsite psychiatric evaluations, and in some cases, can treat patients with comorbid psychiatric conditions or supervise others in providing such treatment. Although it may be ideal for all opioid substitution therapy programs to have a psychiatrist on staff, in many programs it is not feasible. When a psychiatrist is not on staff, the program physician's role is limited to the core functions described below:

• Assessing patient for admission and continued opioid substitution therapy and informing the patient of risks and benefits
• Evaluating the patient's initial response to methadone or LAAM and adjusting the dosage as needed
• Providing assessment and treatment (or referring patient for treatment) of associated medical and psychiatric conditions
• Supervising staff.

Medical Staff

Medical staff includes registered nurses (RNs), licensed practical nurses (LPNs), nurse practitioners, registered nurse clinical specialists (RNCSs), physician assistants, pharmacists, and pharmacy assistants.

• Pharmacists dispense (and in some programs administer) methadone or LAAM, order controlled substances, and keep records.
• RNs and LPNs can administer these medications, maintain records, and facilitate referrals for medical and psychiatric treatment.
• NPs and PAs perform physical examinations of new patients and evaluate and treat patients for some medical problems.
• All nonphysician medical staff members consult with program staff on all aspects of patient care.

Other Professional Staff With Formal Degrees

Social workers typically have master's degrees and training in a wide range of useful skills. Depending on their background and training, they can provide

• Drug and alcohol counseling
• Psychotherapy and family therapy
• Case management
• Pre- and posttest HIV counseling
• Skills training, including job skills, parenting skills, and life skills
• Supervision of other staff who provide these services.

Psychologists have master's degrees or doctorates. Services they provide include

• Psychological testing and evaluation (doctoral level)
• Psychotherapy, including family therapy, for patients with dual diagnoses and with complicated psychiatric conditions
• Consultation to program staff about behavioral therapy strategies
• Supervision of staff.

Vocational and educational specialists usually have master's degrees and provide services such as

• Vocational assessments and making referrals
• Vocational skills training
• Assistance in helping patients obtain a general educational development (GED) certificate and in providing referrals for jobs
• Teaching good work habits.

Addiction Specialists and Drug Counselors

Most substitution therapy programs hire persons with bachelor's degrees or less formal education to serve as addiction specialists or drug counselors. Many have no training in a specific discipline but have an interest in treating addicted individuals. Many have learned drug counseling techniques through their work in methadone or other drug treatment programs or through their own recovery experiences. These persons often serve as the backbone of substitution therapy programs and in some cases provide most of the front-line care. The functions of the counselor and the importance of counseling are addressed in more detail in the section on Counseling, Behavioral Treatments, and Psychotherapy later in this chapter.

Extreme care should be taken in hiring to be certain that recovering individuals are in sustained full remission as defined by the current edition of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (American Psychiatric Association, 1994). Some programs require recovering persons to be in sustained full remission for at least 3 years before being hired and to demonstrate good performance in one or more jobs.

In some programs, counselors have caseloads of 50 or more patients, well above the recommended limit of 35 discussed in Chapter 2. Generally, they

• Address addiction issues and concrete problems via individual and group counseling
• Recommend adjustments in dosage and take-home schedules
• Enforce program rules
• Provide crisis intervention
• Provide case management and make referrals.

Drug counselors also have significant recordkeeping responsibilities. They play a major role in developing the initial treatment plan, monitoring its implementation, explaining the importance of treatment to the patient, updating the plan at specified intervals, and making sure the patient understands the reasons for modifications or adjustments in treatment.

There has been a trend in many programs to upgrade the qualifications of counselors and therapists to require a master's degree in clinical psychology, social work, or a related discipline. In such programs, it is important to match patients to clinicians with the specialized training and professional background to recognize and respond to more complex medical and psychiatric problems.

Administrative Staff

These team members include office managers, secretaries, receptionists, billing department staff, and security staff. They do not have specific treatment responsibility for the patient, but often provide valuable information for the treatment team. Responsibilities include operational management of programs, provision of billing, receipt of payments of clinic fees, record review, observation of milieu interactions, and telephone coverage.

The Treatment Team

Regardless of the backgrounds of various staff members, working as an integrated team is critical to delivering effective services to patients in opioid substitution therapy. Regular staff meetings and case coordination are important components of this strategy. Although it is particularly important to consider the impressions and observations of the patient's counselor and therapist, the definition of the team should not be limited to direct clinical or treatment staff. The team is made up of all individuals who interact with the patient throughout the course of treatment. This includes the program staff as well as offsite primary care clinicians, medical and psychiatric specialists, administrative and treatment staff of affiliated agencies, probation officers, attorneys, advocates, and so forth.

Each team member plays an integral role in the delivery of services and should be considered in the treatment planning process. For example, when a treatment plan or a specific problem with a patient and his or her family is being considered, the program receptionist may have critical information. The program receptionist is the first line of communication with the patient and can observe the patient while he or she is waiting for an appointment or observe interactions with children or family members. The receptionist may talk to the patient on the telephone and be privy to information that others may not readily obtain. Treatment providers from other agencies may have information or observations of the patient that differ from those of onsite program staff. Billing office staff may have information about how the patient handles financial responsibilities. The observations and opinions of the entire treatment team provide varied and valuable information for patient assessment and should be included in the treatment planning process. Participation of all members of the team may be critical to successful interventions.

Continuing Education

Treatment programs generally employ inservice education, case presentations, supervisory sessions, and other methods to maintain and upgrade the skills of the counseling staff. In many States, addiction specialists and drug counselors are offered training courses and can obtain certification in addiction counseling. Most of these, however, provide little or no information about opioid substitution therapy. Like licensed professionals, certified addiction counselors are required to participate in continuing education to keep their certification.

Regardless of counselor status, programs should require all clinicians who provide direct services to participate in continuing education. Participation should be reviewed as part of the employee review process. Topics for continuing education might include HIV, acquired immunodeficiency syndrome (AIDS) and TB, dual diagnosis, homelessness, and counseling techniques such as motivational interventions (Saunders et al., 1991).

Supervision

Clinical supervision ensures that the clinician's work with patients is monitored; it also serves as a vehicle for ongoing training and support. Clinical supervision is particularly critical to identifying transference and countertransference issues in the treatment setting and offering management strategies.

Many individuals, irrespective of professional discipline, bring powerful countertransference issues to the treatment milieu. Countertransference refers broadly to feelings that the therapist has toward his or her patient. When recognized and analyzed, many such feelings can provide valuable insights into the patient and the therapeutic relationship. However, some countertransference feelings are irrational and not useful; they create obstacles to treatment unless they are identified and modified. One common countertransference issue among recovering individuals working in opioid substitution therapy programs is a sense that there is only one path to recovery (generally the path that the recovering individual has taken). Some individuals may also regard patients' dependence on methadone as not legitimate or "real" recovery; they may have a punitive attitude toward patients in the program. Conversely, other staff may be overly supportive or protective of certain patients and unwilling or unable to set reasonable or appropriate limits on inappropriate behavior.

It is important to establish careful screening procedures during job interviews to protect patients from individuals with biases and rigid or even negative ideas about opioid substitution therapy and recovery. Programs should hire staff who are flexible, educated, self-disciplined, and willing to learn, and who get along with a multidisciplinary group.

Recommendations About Dosage

The previous discussion illustrates the importance of establishing individualized dosage levels and the problems associated with a standardized-ceiling approach to treatment. Dosage levels vary among programs and individual patients. However, despite the support for higher doses in the treatment outcomes literature, considerable debate remains about dosage levels, especially about giving patients too much methadone. A rigid approach to dosing levels is inappropriate, inconsistent with the goals of substitution therapy, and contrary to findings of almost every treatment outcomes study that has examined this issue (Cooper, 1992).

These recommendations may result from a fear that it will be more difficult for patients to detoxify and enter a period of sustained remission free of substitution therapy if their methadone dosage level is too high. In fact, this fear appears to be without basis; there is no evidence that higher doses prevent patients from eventually becoming medication free. For example, one study found that those maintained on higher doses (80 mg a day) were more likely to become drug free than those on lower doses (McGlothlin and Anglin, 1981a). To further complicate this situation, some States have set inappropriately low (for example, 40, 60, or 80 mg) limits on the maximum methadone dosage. These limits are not articulated in FDA regulations, which recommend a ceiling of 100 mg and permit dosages of more than 100 mg with clinical justification.

There is some concern in the treatment field that, without upper dosage limits, patients will manipulate the system to obtain higher dosages. Manipulative behavior is common among addicts, and treatment program personnel should be able to distinguish requests that reflect drug-seeking behavior from those that reflect a desire to obtain more control over illicit substance use. Thus, the panel makes the following recommendations:

• Programs should use flexible dosing strategies
• Routine use of low dosages (less than 40 mg a day of methadone) should be discouraged
• The average dosage should be in the range of 60 to 100 mg of methadone a day (or its LAAM equivalent)
• Programs should be allowed to increase dosages to reflect the needs of patients, up to or even over 120 mg.

For some patients, a dosage in the lower end of the range will be sufficient. When adjusting dosages upward, gradual increases (10 mg per week) will reduce the chances of stimulating drug-seeking behavior because patients will become tolerant to euphoric drug effects fairly quickly. Thus, the concern that raising the dosage will stimulate drug-seeking behavior can be greatly reduced by slow dosage increments.

Conditions That May Effect Dose Levels

Medical conditions, medications, and other conditions (for example, pregnancy) affect the establishment and maintenance of adequate methadone (and LAAM) dosage levels. The previous TIP State Methadone Treatment Guidelines provides a detailed discussion of these issues.

Other factors have implications for determining an adequate methadone dose. For example, the purity of heroin available to addicted patients varies. In many urban areas, the available heroin is more potent and cheaper than heroin sold elsewhere. Thus, the amount of heroin a patient reports using daily (reported in bags or spoons of heroin) is not always a reliable indicator of the actual amount of drug being ingested. A patient who reports using a relatively small amount may need higher doses to eliminate withdrawal and craving and to produce an appropriate blockade dose if purity is high. In addition, because of individual differences in metabolism, some patients who report using large amounts of heroin can be stabilized on a lower dosage of methadone, while other patients who are using small amounts of heroin may have higher tolerance to opioids.

Therefore, assumptions about heroin use are not adequate to establish an effective methadone or LAAM dosage. Also, patients increasingly report a return to intranasal heroin use. This change in the route of administration is in part due to increased purity, but is also related to concerns about needle use and fears of HIV transmission from shared drug paraphernalia. These issues have an enormous -- but unquantifiable -- impact on establishing an adequate dosage level of methadone.

It has been well established how important an adequate dosage is to the outcome of opioid substitution therapy. Although many programs are aware of these issues, managed care providers and purchasers of addiction treatment need to be educated about the relationship of adequate dosing to positive treatment outcomes.

Monitoring the Delivery of Services

Simply offering services does not mean that patients will receive them. Thus, mechanisms are needed to ensure that patients receive services, both on- and offsite. The case management model that utilizes the patient's primary counselor is appropriate to use in tracking the receipt of services. The case manager maintains contacts with staff within the treatment program and staff from outside agencies involved in the patient's care. Documentation and recordkeeping are key activities of case management. Standards of documentation and regulatory requirements guide programs in this area.

A comprehensive treatment plan process can also be effective in monitoring service delivery. This approach requires that clinicians and patients set specific goals and measure progress toward achieving these goals within a review period. It also may be appropriate to utilize a global treatment planning model when a single system is delivering a multimodality approach. Under this approach, if a patient requires opioid substitution therapy as well as services from a specialty partial hospitalization program and from a nonhospital rehabilitation program, the treatment plan should include these other modalities. This inclusion facilitates coordination of care and guides therapeutic efforts. It also allows for the verification of service delivery.

Assessment and Continuing Evaluation

As described in Chapter 2, the process of assessing patients for associated problems, developing treatment plans that match patient needs to specific interventions, and integrating these interventions into the overall treatment program forms one of the key aspects of patient-treatment matching within opioid substitution therapy. The assessment forms the basis for matching patients to a range of services. For example, psychotherapy and pharmacotherapy for psychiatric disorders, treatment of HIV and TB, vocational or job counseling, family therapy, legal assistance, and assistance with housing and shelter may need to be provided while the patient continues to receive the core elements of opioid substitution therapy. Participation in self-help groups is usually encouraged as well; some programs have provided space and time so that these groups can meet during clinic hours.

Once a patient has been assessed, a treatment plan is developed in collaboration with the patient. The treatment plan outlines short-term goals (for example, referral to a shelter for adequate housing) and long-term goals (for example, individual, group, or independent living, or engagement of the patient's family in treatment). The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires both short- and long-term goals to be documented in the treatment plan; progress toward them must be measurable. Goal setting should also include a means and a time frame for achieving the goals. Ongoing monitoring should be carried out to ensure that services are received, interventions are working, new problems are identified, and services are adjusted accordingly when problems are resolved.

Among the components of ongoing assessment are review of urine test results, observations based upon patient contact, and review of patient compliance with the treatment plan.

Urine Testing

Urine testing is a vital element of assessment and treatment. It is a tool used to

• Determine patients progress and status in the program
• Determine when patients can move from an acute to a less acute phase of treatment (see Chapter 3)
• Select patients who are allowed to have take-home medications
• Monitor methadone use and intervene in the diversion of take-home medication
• Reveal other substance use problems (for example, use of cocaine or benzodiazepines)
• Determine additional patient treatment needs.

Another TIP is this series, State Methadone Treatment Guidelines, has a separate chapter with detailed discussions of urine screening techniques and methods and of Federal regulations governing these procedures. A brief overview is provided here.

The first urine test is especially important since it is part of the initial evaluation. As noted in the FDA regulations, the presence of opioids in the urine does not establish a diagnosis of opioid dependence, and the absence of opioids does not mean that current dependence does not exist. Thus, the clinical examination and medical history are the keys for determining the appropriateness of opioid substitution therapy. Nevertheless, the admitting urine test is an important piece of data, and it is critical that the sample, as well as other appropriate laboratory tests, be returned from a laboratory in a timely manner. Ideally, throughout the course of treatment, urine tests should be conducted more often rather than less often: at least once a week during the acute phase is recommended. Testing provides initial information for making timely decisions about treatment. It is also an important part of ongoing assessment and planning for continued treatment.

Programs often decrease testing dramatically after the acute phase of treatment because of lack of resources. Programs often operate on budgets that place extreme pressure on the feasibility of doing regular (at least weekly) urine testing. However, the panel strongly recommends that testing be done regularly to the extent possible and that programs continue to pursue funds for urine testing from their funding agencies.

To avoid deception, urines should be collected only under controlled conditions. The best situation is one in which urine specimens can be obtained through direct observation of the patients. Taking the temperature of the specimen immediately after collection is another means that many programs have found to be a reasonably reliable method for assuring compliance. The urine temperature should never be higher than body temperature, and it should not be more than 2 degrees below it. Some programs gauge urine temperature simply by feeling the specimen container by hand. It is important to acknowledge that false positives and negatives occur; thus, if a patient is adamant that a positive result is incorrect, additional specimens should be tested. A laboratory can occasionally make mistakes, but repeated mistakes, especially on samples from the same patient, are highly unlikely.

Patients' refusal to give urine samples is one of the many problems encountered in urine testing. Some patients refuse because they have used illicit drugs and they want to avoid losing privileges (take-home methadone) or are concerned that the program will report their drug use to the probation agency or child protective services. Some patients refuse urines because they have trouble urinating in front of a monitor.

Some strategies are helpful in addressing the issue of refusal. Offering patients water or coffee and asking them to wait for their methadone dose until they can urinate is sometimes helpful. Asking patients to return to the clinic later in the day is another strategy. The policy in some programs is to automatically consider a refusal as an indication of drug use. Regardless of the response, it is important for clinic staff to talk with patients about their concerns about urine testing. To make the appropriate intervention, staff must take the time to understand the problem from the patient's point of view. Many programs do not dispense the daily methadone dose until the scheduled urine sample is obtained, although exceptions are usually permitted in unusual circumstances. Other programs may dispense the medication but require the patient to return later in the day for urine testing. Recently, hair analysis has become available, and it is used by some clinics as a tool to obtain a 90-day drug use picture. However, it is expensive and its use and reliability are in the process of being thoroughly investigated and verified. In the future, if the test is made more economical, hair analysis may constitute a state-of-the art monitoring system.

Neuropsychological Testing

Patients seeking opioid substitution therapy often have cognitive deficits, such as problems in understanding or remembering. These deficits are typically of mild to moderate severity and attributable to the pharmacological effects of abused substances. They generally clear over a period of days to months if abstinence is sustained. Neuropsychological problems that persist warrant formal neurological testing to diagnose the type and severity of the problem and to guide treatment. Such testing is performed by trained professionals, either psychologists or physicians, and such services should be available to the program.

A few patients have severe cognitive deficits that interfere with compliance and other aspects of therapy. Staff should be trained to recognize the needs of these patients. They typically have extensive histories of dependence on alcohol, benzodiazepines, or other sedative drugs; advanced HIV infection; or a history of traumatic head injuries or cerebrovascular accidents. Such patients have difficulty assimilating information unless it is slowly presented and frequently repeated. They may fail at treatment unless special approaches are used. In addition, they are very likely to have difficulty with compliance if they are required to take medications for accompanying medical or psychiatric conditions. In such cases, dispensing the other medications along with the daily dose of methadone will greatly increase the chances of appropriate levels of compliance.

Some patients may have difficulty reading or comprehending written information such as program rules or consent forms because of educational deficits or language difficulties. Such patients can usually be identified by careful observation during intake when they are reading and filling out forms. In most cases, staff can read the information to the patient and ask whether he or she understands it.

Medical Services

Patients entering opioid substitution therapy programs may have one or several comorbid medical conditions. As described in Chapter 2, these conditions include

• HIV/AIDS
• TB
• Hepatitis
• Cirrhosis
• Syphilis and other STDs
• Chronic obstructive pulmonary disease
• Cardiomyopathy and heart disease
• Diabetes
• Hypertension
• Cellulitis.

All of these problems can be treated within the context of the opioid substitution therapy program if assessment is thorough and resources are available, or provisions are made through liaisons with the appropriate specialists. The integration of medical treatment for these and other comorbid conditions presents a major challenge and opportunity for matching strategies and a potentially cost-effective intervention for managed care.

Since associated medical problems may resolve or emerge, programs should establish protocols to screen and evaluate acute problems and to perform periodic reassessments. Periodic routine screenings should be conducted for hepatitis A, B, and C, syphilis, other STDs, TB, and HIV. Liver and kidney function should be routinely evaluated. All of these tests except that for HIV can be done as part of a routine evaluation; HIV testing requires written permission from the patient, along with pre- and posttest counseling. Some programs repeat physical examinations annually, others every 2 years. The panel recommends performing periodic physical examinations no less often than every 2 years and performing tuberculin skin tests every 6 to 12 months.

Administration of medication and treatment is best conducted onsite to observe patient compliance. Onsite services are particularly important for patients who need TB treatment, because they are far less likely to comply with offsite treatment. As discussed above, a recent study by Umbricht-Schneiter and associates (1994) found that compliance with medical care was significantly better when services were provided onsite.

If onsite services are not feasible, it is important to develop strong linkages with appropriate resources, and to monitor patient compliance on a regular basis. This can be done by the counselor, by an NP or PA, or by assigning a staff member to coordinate and to follow up on all referrals to offsite providers.

Psychiatric Services

Patients with untreated substance use and psychiatric disorders do poorly in treatment and often drop out of methadone programs. Thus, it is critical that programs address substance use and psychiatric disorders. It is not appropriate or desirable to withhold methadone treatment from patients with these disorders. The best strategy is to attempt to stabilize the patient's addiction and use appropriate treatments to address AOD disorders and psychiatric problems.

The abuse of cocaine by patients in opioid substitution therapy is a growing problem. A recent report estimated that up to 75 percent of patients in substitution therapy might be abusing cocaine (Avants et al., 1994). Currently, there are no substitution therapies for treating cocaine or sedative dependence. However, a wide range of behavioral and psychosocial treatment interventions have demonstrated efficacy in reducing or eliminating use of these drugs. They include talking therapies, such as individual and group counseling and psychotherapy, and self-help groups. Most of these strategies have been developed and studied in drug-free rehabilitation programs. Manuals to facilitate implementation are available (Raison et al., 1989; Washton, 1992). In addition, Mercer and associates as well as Mercer and Woody have written unpublished manuals (1994) which are also available.

Much less work has been done on systematically developing and evaluating psychosocial treatments for substance use disorders among methadone or LAAM patients. However, treatment outcomes studies have demonstrated significant reductions in cocaine and other drug use among methadone-maintained persons as a consequence of drug counseling and the other psychosocial services (Arndt et. al., 1992; McLellan et al, 1993; Kosten et al., 1992; Magura et al., 1991). These reductions are not as great as those seen for heroin and opioids; however, they are clinically significant and support the value of delivering good drug counseling and other services along with the substitution medication.

Patients with nicotine addiction should be strongly encouraged to quit, especially those who are motivated to do so. Programs should consider offering educational sessions on smoking cessation.

Pharmacological Treatments

Although methadone and LAAM have some antianxiety effects and weak antipsychotic effects, opioid substitution therapy has limited efficacy in addressing these conditions and, in fact, was never intended for this purpose. However, a variety of pharmacological treatments have proven effective in treating these and other psychiatric disorders, and should be used when indicated. Another TIP in this series, Assessment and Treatment of Patients With Coexisting Mental Illness and Alcohol and Other Drug Abuse, has a separate chapter addressing pharmacologic management of patients with dual diagnoses. (Nonpharmacological treatments -- counseling and psychotherapy -- are discussed in a separate section later in this chapter.)

Useful medications include antipsychotics, lithium, and antidepressants. Benzodiazepines are widely used to treat anxiety disorders, but they present special problems with this population because of their widespread abuse. As a result, there is a common belief that benzodiazepines are contraindicated in methadone patients; however, there are no studies that confirm this belief. A large number of studies indicate major differences in the abuse liability among benzodiazepines. Those having a rapid onset of action (alprazolam and diazepam) appear to have significantly higher abuse liability than drugs of the same class having a slower onset, such as oxazepam (Serax). Since these drugs have a very wide margin of safety and are effective in reducing anxiety even when used over extended periods of time, the use of benzodiazepines with a low abuse liability for selected patients may be helpful and is worthy of further study. In fact, there are several case reports in which benzodiazepines, particularly those with very low abuse liability, have been used with success among selected patients with substance use disorders (Adinoff, 1992; American Psychiatric Association, 1990; Griffiths et al., 1984; Sellers et al., 1993).

The nonbenzodiazepine buspirone (BuSpar) has none of the sedative effects of benzodiazepines and thus its abuse potential is essentially nonexistent. It has a slower onset of action than other antianxiety drugs, which may account for its low rate of use. It has some antidepressant effects. Investigative clinicians continue to learn more about the effects of this medication, which has a complex profile and may affect a multitude of symptoms. Tricyclic antidepressants have been used with some success to treat anxiety disorders in this population.

Acupuncture

Acupuncture may provide some symptom relief for patients having difficulty managing anxiety, or it may be used as an adjunct to outpatient detoxification from benzodiazepines or alcohol. Acupuncture is the use of thin needles inserted subcutaneously at points on the body believed to be related to organs in need of stimulation. Electro-acupuncture applies small amounts of electricity to needles or staples at body points believed to affect opioid withdrawal. The use of acupuncture for the treatment of opioid withdrawal was first reported by Wen and Cheung in 1973. Its efficacy has been questioned by many ("Acupuncture: the Position Paper of the National Council Against Fraud," 1991; Alling et al., 1990; Ter Reit et al., 1990; Whitehead, 1978).

Although research on acupuncture in the treatment of opioid withdrawal is limited, it appears to be somewhat effective in reducing both objective withdrawal and subjective discomfort. Acupuncture may be helpful during withdrawal as an adjunctive treatment to the psychosocial approach. It may be a helpful alternative to alleviate withdrawal discomfort for opioid substitution therapy patients who seek outpatient, nonpharmacological treatment alternatives for cocaine dependence or for low levels of benzodiazepine dependence. More research is needed to determine what techniques are helpful, how acupuncture works, and how it relates to more traditional interventions (Kleber, 1994).

Individual and Group Counseling

The major focus of counseling is to provide support and guidance, especially to stop AOD use; to monitor problematic behaviors; to help the patient comply with clinic rules; and to offer referrals to medical, social, and legal services. Counseling provides support for a drug-free lifestyle and encourages abstinence from AODs. The Center for Substance Abuse Treatment (CSAT) has recently published Treatment of Opiate Addiction With Methadone: A Counselor Manual. This manual facilitates the training of new counselors and improves the quality of the counseling component in methadone treatment.

In individual counseling, the patient meets with a counselor periodically, from once a month to several times a week. Some patients in the acute phase of treatment meet with a counselor daily. The frequency of sessions varies according to the patient's condition, the phase of treatment, and sometimes the State's provisions. In some States, Medicaid regulations and contracts may require or limit services for methadone patients regardless of their needs or treatment phase.

The counselor providing services

• Reviews urinalysis reports
• Encourages the patient to talk about important personal or family issues
• Helps the patient resolve acute social or personal crises
• Encourages the patient to seek and maintain gainful employment
• Provides liaison services with physicians, courts, and social service agencies
• Encourages the patient to discuss problem areas, such as ongoing health and financial problems
• Arranges for changes in methadone dosage or take-home medication
• Helps the patient comply with program rules and policies.

Counselors also help patients with problems in other areas, such as dealing with the criminal justice system or arranging transportation to obtain medical services.

Standard components of AOD counseling include

• Motivation enhancement
• Education about addiction and the effects of AODs
• Education about relapse prevention strategies, such as how to avoid or best respond to "people, places, and things" that trigger drug craving
• Identification of special unexpected problems
• Assistance in compliance with program rules and regulations
• Stress and time management techniques
• Assistance in structuring waking time and setting up schedules
• Assistance in developing a healthy lifestyle involving exercise, good nutrition, smoking cessation, and avoidance of risky sexual practices
• Assistance in becoming involved in socially productive activities such as community organizations, church groups, or self-help groups such as Narcotics Anonymous (NA) or Methadone Anonymous (MA).

A typical counseling session might include the following activities:

• Reviewing results of urine tests
• Reviewing the treatment plan
• Identifying measurable goals and time frames
• Reviewing the patient's progress in achieving the treatment goals, including abstinence and abstinence-related behaviors
• Discussing legal and family problems, such as reporting to probation officers or complying with safety contracts that were implemented as a result of abuse of family members
• Reviewing emergencies and how to address them.

When the primary counselor serves as case manager, he or she provides a liaison with other services. Medical staff should discuss a patient's medical problems with his or her counselor so that the counselor can help the patient understand the importance of complying with medical treatment and keeping appointments. In turn, the counselor should convey to medical staff any observations about the patient's medical condition.

Although counselors are not expected to understand medical treatments, pathophysiology, or pharmacotherapy in the same way that a medically trained professional does, they should have some general knowledge of common medical conditions and their treatment. This knowledge enables counselors to work more closely and effectively with medical and psychiatric staff in developing matching strategies that combine medical, psychiatric, and drug-focused treatments.

The type, frequency, and duration of group counseling sessions vary significantly by program. Some groups keep the same membership and stay together for a limited time; others are more long term and may involve a "rolling" membership. Some groups are psychoeducational, with a curriculum including workbooks and homework assignments. Formats or topics for each session are designed to provide a strong structure, using models that have been adapted from those used in drug-free rehabilitation programs.

• Common psychoeducational group counseling topics include
• Drug education and drug cessation (including focused lectures on these topics)
• Dynamics of addiction
• Medical effects of certain drugs
• Medical impairments
• Impact of drug use on families
• Introduction to self-help groups such as NA.

Other topics designed to provide a strong structure may include

• Leisure activities
• Interpersonal relationships
• Drinking and driving
• Building self-esteem
• Dynamics of relapse
• Medications
• Psychiatric illnesses
• Side effects of methadone
• Skill-building and relapse prevention
• Stress management and relaxation
• Assertiveness training
• Communication skills training
• Time management
• HIV/AIDS
• Nutrition and exercise
• Smoking cessation
• Parenting groups
• Other compulsive behaviors.

Ideally, groups should be led by individuals trained in group therapy. Most State agencies offer basic training courses in group process and group dynamics. Group counseling sessions are often directed by following guidelines in a manual. Use of a manual allows different staff to lead particular groups and permits programs flexibility in running groups; it also ensures that all groups cover standard information. Manuals for use in opioid substitution therapy are not as common as those for drug-free programs. However, the same principles can easily be adapted to methadone patients. The necessary step is to emphasize the need to take the prescribed pharmacotherapy, but no other substances.

Some groups, such as process-oriented groups, are not compatible with use of a manual, but are highly effective in helping patients change their attitudes and behaviors. For example, some patients are resistant to group therapy and refuse to attend. Offering small process groups specifically geared toward these patient's concerns and needs allows the therapist to explore the patients' resistance to groups and past group therapy experiences and to address fears of talking in a group setting. In forming groups, programs should also consider mixed groups -- for example, men and women and stable and unstable patients. Such groups are often more beneficial than extremely homogeneous groups.

Parenting Groups

Many patients who enter opioid substitution therapy programs have children. Many have lost custody of their children (either temporarily or permanently) because of substance abuse and addiction problems. Concerns about children and parenting can be an important focus of treatment. For some, these concerns are the motivating factor that brings them into treatment. Developing groups for patients who are concerned about their parenting skills can be very valuable in engaging them in the recovery process.

Groups may be educational and address specific topics, including information about Child Protection Services, resource availability, day care services, breastfeeding and methadone, and so forth. Skill-building groups for parents often address limit setting and appropriate discipline; divorce, visitation, and parenting; and dealing with a sick child. Psychodynamic groups for parents help patients explore issues such as ambivalence about losing a child, fear of parenting, and coping with anger, shame, and guilt. Programs should ask patients what their needs are in these areas and develop groups accordingly.

Family Counseling

Family interventions can be done in an individual or group format. They are generally of two types: counseling interventions and family therapy. The interventions are discussed in the section on psychotherapy. Family counseling consists of one or more sessions that includes educational information and gives participants the opportunity to ventilate feelings and describe problems. Some families have very negative attitudes about substitution therapy and need considerable education about its benefits. In these groups, family members learn about the treatment program and how to support the efforts of the patient and staff to treat the dependence and associated problems. This type of intervention can usually be done by counseling staff, sometimes with the brief assistance of a psychiatric social worker or psychiatrist.

Some programs have a monthly "family night" or some other forum for ongoing family involvement. In these settings, all family members of patients are invited to an informal gathering to discuss their concerns or questions about the program or their relative's progress. This ongoing format can be very helpful in providing family support for therapy, and for identifying acute family problems that need more focused treatment.

In deciding whether a family requires psychotherapy for more serious, multigenerational problems that might be helped by a family approach to drug use, a good evaluation is essential. One approach is to have a psychiatric social worker who has been trained in family therapy, or a person who specializes in family therapy interview every new patient as part of the initial evaluation. Information obtained at this interview, often supplemented with information obtained during the acute phase of treatment, can then be used to determine if family therapy is indicated.

Other Types of Counseling

In addition to drug-focused counseling and family therapy, specialized, highly focused counseling is available for several issues, including

• Relapse prevention, often combined with time management strategies
• Sexually transmitted diseases and responsible sexual behavior
• Vocational counseling (sometimes linked with cognitive testing and conducted in collaboration with vocational agencies)
• Smoking cessation
• Nutrition (a dietician or nurse discusses nutrition, including special needs of HIV-infected persons)
• Exercise, including aerobic types of exercise and
• meditative exercise such as yoga (a dietician or nurse can facilitate discussion)
• HIV pre- and posttest counseling
• Support groups.

The last two issues are especially important and are discussed in more detail below.

Behavioral Treatments

Behavioral treatments are derived from the principles of learning and behavior change developed by psychologists and behavioral scientists. AOD abuse and dependence are seen as involving major elements of learning and as being influenced by many aspects of the patient's environment and circumstances. Many elements of this behavioral view and of behavioral treatments are now widely accepted and routinely incorporated into substance abuse education and counseling. For example, the emphasis on identifying high-risk circumstances that increase the likelihood of AOD use and of developing alternative coping responses to those circumstances is derived from a behavioral approach, as is the emphasis on developing personally rewarding activities as alternatives to AOD abuse and related activities.

Another aspect of behavioral treatment that can be beneficial in conjunction with methadone treatment is the use of behavioral incentives or contingencies to motivate and reward therapeutically appropriate behaviors. Incentives may be provided and may be effective in increasing a wide variety of desirable outcomes: maintaining negative urine specimens, attending counseling sessions, keeping medical appointments, and working or volunteering. One of the most effective rewards available in methadone clinics is the medication take-home privilege. Other potential incentives or rewards include increasing or decreasing counseling services, scheduling administration of methadone at specific and more desirable times of day, and facilitating access to goods or services such as meal vouchers, gift certificates, entertainment tickets, and toys for patients' children. Designing such incentive or reward programs may require significant effort but it can add an important dimension to a treatment program.

An important principle of behavioral treatment is that positive incentives or rewards for desirable behavior are more effective than negative or punishing consequences or threats for undesirable behavior. This is a critically important principle, and one that is often difficult for treatment staff to learn and implement. Negative or punishing consequences tend to have the undesirable effect of driving patients out of treatment rather than retaining them and encouraging as much improvement as attainable. To be most effective, behavioral treatment contingencies should be clearly spelled out and reliably and consistently implemented. Contingencies can be either individualized for patients based on specific areas of behavior change or implemented on a uniform, program-wide basis. Either strategy is acceptable. The efficacy of behavioral incentive treatments has been demonstrated in several well-designed studies (Boudin, 1972; Daley and Marlatt, 1992; Melin et al., 1976; Stitzer et al., 1992). Such treatments are especially effective when medication take-home privileges have been made contingent upon providing drug-free urine samples.

When patients are being considered for administrative termination from treatment because of nonresponse, it may be especially worthwhile to spell out to patients a specific set of behavioral contingencies that can lead to their retention in treatment. For example, a patient who consistently fails to attend prescribed counseling sessions might be informed that a gradual detoxification will be initiated but that it will be terminated and the patient's dose gradually restored contingent upon attending the prescribed sessions.

Psychotherapy

The term psychotherapy is often used synonymously with counseling but it has a significantly different focus. While drug counseling focuses mainly on external events and processes, psychotherapy aims to identify and modify intrapsychic processes that contribute to the substance use disorder and interfere with treatment progress. Psychotherapy is most often used to treat patients whose psychiatric distress interferes with their ability to participate in routine treatment. Because of the instability of many patients in the acute phase of treatment, methadone patients usually begin psychotherapy late in the acute phases or after entering the rehabilitation phase. In the methadone treatment context, psychotherapy tends to be more time limited than counseling. Psychotherapy is often combined with pharmacotherapy and counseling.

Psychotherapy was originally developed to treat nonpsychotic psychiatric disorders such as anxiety and depression. It has been used with persons who have substance use disorders and has been found effective for psychiatrically impaired patients in substitution therapy programs, but only when combined with substitution therapy and drug counseling (Woody et al., 1983; 1984; in press ).

There are many schools of psychotherapy, and several methods have been used in opioid substitution programs. Among these are cognitive-behavioral psychotherapy, supportive-expressive psychotherapy, and interpersonal psychotherapy. It is beyond the scope of this TIP to describe these psychotherapies in detail; however, it should be noted that they have been most successfully used with patients who have significant levels of nonpsychotic psychiatric symptoms. These patients are sometimes described in the literature as being "high severity," and they typically do not respond well to the drug-focused counseling available in methadone programs. Several authors have described effective psychotherapeutic approaches to these patients (Luborsky et al., 1994; Beck et al., 1993).

Spirituality

Spirituality refers to an involvement in socially desirable activities or processes that are beyond the immediate details of daily life and personal self-interest. Ethical behavior, consideration for the interests of others, community involvement, helping others, and participating in organized religion are all ways in which spirituality can be expressed. Persons who recover from substance use disorders often experience an increased interest in the spiritual aspects of their lives, and addressing a person's spirituality is widely recognized as an important aspect of recovery. For example, assessment of spirituality is required by the Joint Commission on Accreditation of Healthcare Organizations, and the development of that aspect of one's personal life is encouraged by most self-help groups.

Approaching patients in relation to their spirituality can also provide an opportunity for the patient to connect or reconnect with community and family. This process can begin with the initial assessment which helps establish the patient's cultural context. For example, if a patient who was raised in a church-going family has not attended church in a long time, there may be a need to address underlying issues about that individual's adjustment in the community. Psychosocial treatment could involve persuading the individual to return to church as part the process of reconnecting with the community and family, gaining acceptance, and forgiving himself or herself.

Children

Lack of adequate childcare is a barrier for many single working parents in substitution therapy programs. For example, some patients report missing clinic dosing hours or scheduled counseling appointments because they have no one to watch their children. Some bring their children to the clinic and into counseling sessions; this alternative makes it difficult for the patient and counselor to have the privacy and concentration to have productive sessions. Some may arrange for another patient to watch their children while they attend counseling, but this is not always practical, available, or desirable.

Ideally, waiting rooms should be able to accommodate children. However, some programs lack physical space and are not safe for children because they do not have a separate or secure room with adult supervision (for times when patients are with staff in treatment sessions). Lead paint and asbestos often found in many urban facilities may pose another hazard to children. Programs without space must require patients to have immediate control of their children so that they do not disrupt treatment. Some programs prohibit children in the facility out of concern that their presence poses a danger to them or a distraction to patients' focus on recovery. Some programs allow patients to bring their children to the facility early in treatment so that childcare concerns will not interfere with treatment.

Childcare services available onsite that allow patients to leave their children in a supervised environment are ideal. Structured childcare services provide an opportunity for observation, assessment, and problem identification, which can be valuable in planning a patient's treatment program. Childcare services are strongly recommended for the relatively small subgroup of substitution therapy programs that provide outpatient hospital treatment.

Many programs have limited resources, and childcare services are currently available in very few programs. Developing arrangements for childcare is a challenging -- but not impossible -- task. A program may develop a collaborative project with an area college or university that has a child development program. The program can provide the space and a coordinating staff member, while the college could provide students who need child assessment experience and supervision. Another alternative would be for two or more service providers to jointly develop a childcare program or negotiate a contract with a childcare facility. The proposed Federal block grant regulations on set-aside services for women will probably increase support for programs to institute childcare services and should stimulate their development.

Although childcare services clearly benefit patients, programs must be careful when considering taking on childcare responsibilities because of issues related to licensing and insurance. Staff should not be expected to provide childcare services unless they are specially equipped to do so.

Access for the Disabled

Increasingly, methadone treatment facilities are faced with developing ways to address the needs of disabled patients. Many patients with AIDS have disabilities such as blindness or are sometimes not strong enough to visit the clinic. Other patients have hearing impairments or other physical handicaps.

At the very least, programs should be well maintained and barrier free. Programs should be aware of measures necessary to comply with the Americans With Disabilities Act. They should provide wheel chair accessibility, handicapped-accessible bathrooms, access for patients with seeing-eye dogs, Telecommunications Device for the Deaf (TDD) machines, and sign language services. If services are not available onsite, provisions should be made through contracted agreements and used on an as-needed basis.

Because of the growing number of patients who are unable to visit the clinic daily as a result of disabilities, home dosing with methadone has become an increasing need. Although many patients can be provided with take-home medication, not all patients are eligible. For example, some patients with AIDS or other medical problems that affect neurological functioning are unable to manage their medication without supervision. Other medically compromised patients may continue to use illicit drugs or abuse alcohol and are ineligible for take-home dosing. These patients pose major dilemmas for opioid substitution programs and treating them requires creative planning.

Solutions vary from program to program and in different geographic areas. For those who do not meet take-home eligibility criteria, home dosing can be negotiated under the Federal regulations emergency dosing provisions. For example, some programs identify a responsible family member or significant support person to assist in the dosing process. With the patient's permission, these individuals are educated about methadone and are responsible for picking up the methadone from the program, ensuring safe storage (for example, locked boxes and limited key access), and administering the medication daily. For patients who cannot identify such a person, programs may negotiate services through the Visiting Nurses Association or comparable programs to assist in this process.

Some programs deliver the medication directly to the patient's home. This delivery may be impractical for programs that serve patients who live a great distance from the clinic and is costly for programs that do not have adequate staff. Switching from methadone to LAAM can also be considered in these cases because the long-acting nature of LAAM allows patients to visit the clinic for dosing every other day rather than daily.

Regardless of the strategy, meeting the needs of homebound patients is a challenge for all involved. This service can be time consuming and expensive, and it can introduce safety and security dilemmas. Consideration may be given to negotiations with pharmacies or interested physicians who could work directly with a licensed narcotics treatment program to propose solutions for home dosing in geographically inaccessible areas. Programs are encouraged to engage in discussions with their State agencies, the DEA, and Federal and local FDA agencies to assist in developing creative solutions.

Nonfraternization Between Patients And Staff

Programs must establish clear standards barring outside engagement between program personnel and patients, including prohibitions on dates and intimate or financial involvement of any kind. Patients not infrequently offer to sell goods or services to program staff. Staff should not be patients' sponsors in 12-step programs, although it is acceptable if they meet at 12-step meetings. If staff fraternize with patients in these ways, the boundaries necessary to provide effective medical and clinical services will be compromised, and the treatment process will probably be negatively affected.

Noncompliance

Repeated skipping of methadone doses should be an indicator of a problem situation. Reasons for missed doses include incarceration, hospitalization, changed work schedules, or transportation difficulties. Programs should establish a certain number of missed days per month (for example, 3 missed days) as indicative of a treatment problem. Programs can approach such situations by mobilizing staff to identify problems and determine a response. Rarely should patients be administratively discharged simply for missing appointments.

Although some patients may be eager to receive counseling and other psychosocial services, patients generally request admission to a methadone program in order to receive methadone. They may not want other services, at least at the time they apply for treatment. If methadone were not available, many opioid-dependent persons would not seek help or be receptive to receiving it. However, regular counseling appointments have been shown to be associated with significantly improved treatment outcomes (McLellan, et al., 1993). Thus, the program should expect and even demand participation in an appropriate level of psychosocial treatment. This level should be determined by the patient's clinical status. Some severely impaired patients may require several hours per week of care, while others will require considerably less.

Certain treatment issues, especially those that relate to public health, should not be negotiated with patients. For example, testing and treatment for TB should be required because of the its contagious nature. Although HIV can be transmitted to others, stipulating that patients must be tested for HIV may drive opioid users away from treatment because they fear the consequences of learning that they are HIV positive.

Summary

The recommendations made in this chapter are summarized below.