Comercio Internacional

BACKGROUND

In general, patients requiring greater structure and intensity of comprehensive treatment services including mental health, medical, and social services, may be better served in an Opioid Agonist Treatment Program (OATP). Provision of care at OATPs is highly regulated, with provider and patient-level requirements including limited take home medications provided, mandated laboratory studies and clinical assessments, appropriate psychosocial intervention, and formal agreements for the provision of OAT. In office-based opioid treatment (OBOT) for medical maintenance by credentialed physicians, patients usually receive less intensive services (e.g., less psychosocial services needed to prevent relapse) either within an addiction specialty care program or in a setting similar to treatment of other medical conditions.

Deciding on whether a patient requires opioid agonist treatment in a specialized OATP depends on matching treatment resources to each individual patient’s needs.

VA/DoD Clinical Practice Guideline For Management of Substance Use Disorders

Module P - Page 59

RECOMMENDATIONS

1. Individualize the choice of setting based on patient characteristics and availability of facilities to treat patients with opioid agonist therapy (OAT). See Table P-2.

2. Appropriate psychosocial interventions should be provided as part of the opioid agonist therapy (OAT). [A]

DISCUSSION

Opioid agonist therapy (OAT) can be delivered through opioid agonist treatment program (OATP) or through office-based treatment (OBOT). OATPs are structured, licensed facilities that are not available to each VHA facility. However, OATPs, or “methadone facilities,” may be located in proximity to a VHA or near the veterans domicile. Most OATPs provide both medically supervised withdrawal and rehabilitation services. Most OATPs provide comprehensive services including individual therapy, group therapy, and family counseling. OATPs can provide OAT in the form of methadone and buprenorphine. Most OATPs are providing predominantly methadone. Provision of care at OATPs is highly regulated, with provider and patient-level requirements including limited take home medications provided, mandated laboratories and assessments, appropriate psychosocial intervention, and formal agreements for the provision of OAT.

OBOT for opioid dependence can only be provided by credentialed physicians. Buprenorphine is the only medication approved for OBOT. Minimum resources necessary to provide OBOT using buprenorphine include history and physical exam, availability to obtain laboratories including urine drug testing, and access to additional counseling and treatment services. OBOT using buprenorphine can be provided in residential and outpatient arrangements and any environment not directly associated with OATP. If providing buprenorphine within the confines of an OATP, all OATP

requirements/regulations must be met.

Fiellin et al. (2006) randomized subjects to one of 3 conditions: 1) one 45 minute counseling session per week plus thrice weekly buprenorphine dispensing; 2) one 20 minute counseling session per week plus thrice weekly buprenorphine dispensing; 3) one 20 minute counseling session per week plus once weekly buprenorphine dispensing. Outcomes (illicit opioid use and treatment retention) did not differ by condition. Thus, a more intensive amount of psychosocial treatment was not better than a modest amount of psychosocial treatment.

Peer reviewed evidence evaluating system-, provider-, or patient-level factors that would assist the provider in determining whether a patient is most appropriate for OATP or OBOT care is currently not available, but several principles apply. If the facility has access to an OATP, and the patient is willing to accept OAT care through the OATP, patients should be directed to explore OATP care. If the facility does not have access to an OATP, OBOT care should be available. Patient level factors that would steer a provider to recommend an OATP over OBOT are the following: pregnancy (high level evidence), severe opioid dependence (high-mod evidence), co-existing pain syndromes requiring opioids (high level of evidence), and social/environmental instability (low level of evidence). Currently, the “gold standard” treatment of a pregnant opioid dependent patient is OATP care using methadone. This care has significant history, is well known to most providers, and has much evidence for efficacy for the mother, fetus and newborn. Patients who use significant amounts of opioids and who have a high level of physical dependence and tolerance may be better treated with methadone through an OATP (moderate level of evidence). Patients who have co-occurring pain syndromes, requiring OAT and opioids for pain control should be treated within an OATP as concurrent use of opioid medications for pain and buprenorphine presents management challenges and may be ineffective. Social and environmental factors (e.g., homelessness, marital discord, dangerous living environments) may prompt a provider to suggest OATP over OBOT care as OATP care generally has more access to wrap around services that may assist in the patient recovery (e.g., vocational training, housing assistance, family counseling). Recent evidence suggests that OBOT can be provided with success to the homeless and patients with social/environmental stressors, but OATP care is likely the preferred choice.

Module P - Page 60

A systematic review (Amato et al., 2004) concluded that adding any psychosocial support to standard methadone maintenance therapy reduced the use of heroin during treatment. Based on eight studies (N=510) the relative risk for retention in treatment was 0.94 (95%CI 0.85 to 1.02), and based on three studies (N=250) the relative risk for abstinence at the end of follow-up was 0.90 (95%CI 0.76 to 1.07). While these findings showed a trend towards improved outcomes by adding any psychosocial support, they did not reach statistical significance.

Scherbaum et al. (2005) compared methadone plus psychosocial intervention (cognitive behavioral training [CBT]) versus methadone alone. This RCT found a significant difference in drug use between methadone plus CBT versus methadone alone. Retention rates were 63 percent and 59 percent, and abstinence rates or percentage of negative urine were 29 percent and 52 percent respectively. Patients who have difficulty accessing an OATP (e.g., large geographical distances, lack of

transportation) may be better treated in OBOT using buprenorphine. Recent evidence suggests that use of buprenorphine may be preferable to methadone due to drug-drug interactions of medications taken for co-occurring conditions (e.g., anti-retroviral medications for HIV). OBOT care using

buprenorphine may also be preferred over OATP care for patients with opioid dependence, but with intermittent use of opioids and who do not have a significant amount of physical dependence and tolerance of opioids.

Table P- 2. Patient Suitability for Office-Based Opioid Treatment versus Opioid Treatment Program*

Criteria Office-Based Opioid Treatment (OBOT)

Opioid Agonist Treatment Program (OATP)

Can an office-based setting provide needed

resources for the patient Yes No

Patint’s psychosocial supports Good Poor

Level of opioid dependence Mild to Moderate High

Co-occurring psychiatric disorders Stable Unstable (e.g., chronically _suicidal)

Co-occurring medical disorders Stable Unstable

Dependence on CNS depressants (e.g. alcohol,

benzodiazepines) No Yes

Pregnancy No Yes

Previous failed treatment attempts, especially with

opioid agonists None/Few Many

Response to sublingual buprenorphine in the past Good Poor Expected to be reasonably compliant in treatment Yes No

* A considerable amount of medical decision-making is required to determine the best setting for each individual patient. If the setting chosen initially is not appropriate, the patient can be switched to the alternative setting with appropriate monitoring.

VA/DoD Clinical Practice Guideline For Management of Substance Use Disorders

Module P - Page 61

EVIDENCE TABLE

Evidence Source QE Overall Quality

Net Effect

SR

1 Insufficient data to determine if one setting of care is better (OBOT vs. OATP).

Working Group Consensus III Poor NR I

2 Methadone with counseling is better than methadone alone.

Amato et al., 2004 McLellan et al., 1993 Scherbaum et al., 2005

I Good Subst A

QE = Quality of Evidence; NR= Not Relevant; SR = Strength of Recommendation (See Appendix A)

E. Initiate Opioid Agonist Treatment in an Opioid Agonist Treatment Program (OATP) or Office-