What follows is the executive summary of the guideline; for more detailed information on the recommendations, please see the original guideline document.
Patient Assessment
An approach to the screening, assessment, and diagnosis of opioid addiction problems, and for determining when buprenorphine is an appropriate option for treatment is provided in Chapter 3 of the original guideline document. The necessary first steps in the medical management of opioid addiction are (1) the use of validated screening tools to identify patients who may have an opioid use problem and (2) further assessment to clearly delineate the scope of an opioid addiction problem when one is identified. When treatment is indicated, consideration must be given to the appropriate treatment approach, treatment setting, and level of treatment intensity, based on a patient’s preferences, addiction history, presence of medical or psychiatric comorbidities, and readiness to change. Buprenorphine is a treatment option for many, but not for all.
Screening
The Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction Consensus Panel recommends that physicians periodically and regularly screen all patients for substance use and substance-related problems, not just those patients who fit the stereotypical picture of addiction. Several validated addiction or substance use dependence screening instruments are discussed. The full text of selected screening instruments is provided in Appendix B of the original guideline document, Assessment and Screening Instruments.
Assessment
If screening indicates the presence of an opioid use disorder, further assessment is indicated to thoroughly delineate the patient’s problem, to identify comorbid or complicating medical or emotional conditions, and to determine the appropriate treatment setting and level of treatment intensity for the patient. Complete assessment may require several office visits, but initial treatment should not be delayed during this period.
The Guidelines document provides recommendations on effective interviewing techniques and on the components of the complete history, physical examination, and recommended initial laboratory evaluation of patients with opioid addiction.
The consensus panel recommends that initial and ongoing drug screening should be used to detect or confirm the recent use of drugs (e.g., alcohol, benzodiazepines, barbiturates), which could complicate patient management. Urine screening is the most commonly used and generally most cost-effective testing method.
Diagnosis of Opioid-Related Disorders
After a thorough assessment of a patient has been conducted, a formal diagnosis can be made. As a general rule, to be considered for buprenorphine maintenance, patients should have a diagnosis of opioid dependence, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). This diagnosis is based not merely on physical dependence on opioids but rather on opioid addiction with compulsive use despite harm. (See DSM-IV-TR diagnostic criteria in Appendix C of the original guideline document, DSM-IV-TR Material.)
Determining Appropriateness for Buprenorphine Treatment
A detailed approach to determining the suitability of buprenorphine as a treatment option for patients with opioid addiction is included in the Guidelines. The evaluation includes determining if appropriate patient motivation exists and ruling out contraindicating medical and psychiatric comorbidities.
Patients for whom buprenorphine may be an appropriate treatment option are those who:
- Are interested in treatment for opioid dependence
- Have no contraindications to buprenorphine treatment
- Can be expected to be reasonably compliant with such treatment
- Understand the benefits and risks of buprenorphine treatment
- Are willing to follow safety precautions for buprenorphine treatment
- Agree to buprenorphine treatment after a review of treatment options
Patients less likely to be appropriate candidates for buprenorphine treatment of opioid addiction in an office-based setting are individuals whose circumstances or conditions include
- Comorbid dependence on high doses of benzodiazepines or other central nervous system depressants (including alcohol)
- Significant untreated psychiatric comorbidity
- Active or chronic suicidal or homicidal ideation or attempts
- Multiple previous treatments for drug abuse with frequent relapses (except that multiple previous detoxification attempts followed by relapse are a strong indication for long-term maintenance treatment)
- Poor response to previous treatment attempts with buprenorphine
- Significant medical complications
Treatment Protocols
Detailed protocols for the use of buprenorphine in the treatment of opioid addiction are provided in Chapter 4 of the original guideline document. A variety of clinical scenarios are addressed, including whether patients are addicted to long- versus short-acting opioids, and whether the approach selected is maintenance treatment or medically supervised withdrawal (which must be followed by long-term drug-free or naltrexone treatment to be useful to the patient).
Maintenance Treatment
Maintenance treatment with buprenorphine for opioid dependence consists of three phases: (1) induction, (2) stabilization, and (3) maintenance. Induction is the first stage of buprenorphine treatment and involves helping patients begin the process of switching from the opioid of abuse to buprenorphine. The goal of the induction phase is to find the minimum dose of buprenorphine at which the patient discontinues or markedly diminishes use of other opioids and experiences no withdrawal symptoms, minimal or no side effects, and no craving for the drug of abuse. The consensus panel recommends that the buprenorphine/naloxone combination be used for induction treatment (and for stabilization and maintenance) for most patients. The consensus panel further recommends that initial induction doses be administered as observed treatment; further doses may be provided via prescription thereafter.
To minimize the chances of precipitated withdrawal, patients who are transferring from long-acting opioids (e.g., methadone, sustained release morphine, sustained release oxycodone) to buprenorphine should be inducted using buprenorphine monotherapy, but switched to buprenorphine/naloxone soon thereafter. Because of the potential for naloxone to precipitate withdrawal, pregnant women who are deemed to be appropriate candidates for buprenorphine treatment should be inducted and maintained on buprenorphine monotherapy.
The stabilization phase has begun when a patient is experiencing no withdrawal symptoms, is experiencing minimal or no side effects, and no longer has uncontrollable cravings for opioid agonists. Dosage adjustments may be necessary during early stabilization, and frequent contact with the patient increases the likelihood of compliance.
The longest period that a patient is on buprenorphine is the maintenance phase. This period may be indefinite. During the maintenance phase, attention must be focused on the psychosocial and family issues that have been identified during the course of treatment as contributing to a patient’s addiction.
Medically Supervised Withdrawal ("Detoxification")
Buprenorphine can be used for the medically supervised withdrawal of patients from both self-administered opioids and from opioid agonist treatment with methadone or levo-alpha-acetyl-methadol (LAAM). The goal of using buprenorphine for medically supervised withdrawal from opioids is to provide a transition from the state of physical dependence on opioids to an opioid-free state, while minimizing withdrawal symptoms (and avoiding side effects of buprenorphine).
Medically supervised withdrawal with buprenorphine consists of an induction phase and a dose-reduction phase. The consensus panel recommends that patients dependent on short-acting opioids (e.g., hydromorphone, oxycodone, heroin) who will be receiving medically supervised withdrawal be inducted directly onto buprenorphine/naloxone tablets. The use of buprenorphine (either as buprenorphine monotherapy or buprenorphine/naloxone combination treatment) to taper off long-acting opioids should be considered only for those patients who have evidence of sustained medical and psychosocial stability, and should be undertaken in conjunction and in coordination with patients’ Opioid Treatment Programs (OTPs).
Nonpharmacological Interventions
Pharmacotherapy alone is rarely sufficient treatment for drug addiction. For most patients, drug abuse counseling—individual or group—and participation in self-help programs are necessary components of comprehensive addiction care. As part of training in the treatment of opioid addiction, physicians should at a minimum obtain some knowledge about the basic principles of brief intervention in case of relapse. Physicians considering providing opioid addiction care should ensure that they are capable of providing psychosocial services, either in their own practices or through referrals to behavioral health practitioners in their communities. In fact, DATA 2000 stipulates that when physicians submit notification to the Substance Abuse and Mental Health Services Administration (SAMHSA) to obtain the required waiver to practice opioid addiction treatment outside the OTP setting, they must attest to their capacity to refer such patients for appropriate counseling and other nonpharmacological therapies.
Treatment Monitoring
Patients and their physicians together need to reach agreement on the goals of treatment and develop a treatment plan based on the patient’s particular problems and needs. During the stabilization phase, patients receiving maintenance treatment should be seen on at least a weekly basis. Once a stable buprenorphine dose is reached and toxicologic samples are free of illicit opioids, the physician may determine that less frequent visits (biweekly or longer, up to 30 days) are acceptable. During opioid addiction treatment with buprenorphine, toxicology tests for relevant illicit drugs should be administered at least monthly.
Special Populations
The approach to patients who have certain life circumstances or comorbid medical or behavioral conditions that warrant special consideration during the assessment and treatment of opioid addiction is discussed in Chapter 5 of the original guideline document.
Patients With Medical Comorbidities
Patients who are addicted to opioids often have other medical comorbid problems as a consequence of both high-risk behaviors and of direct toxic effects of the active and inert ingredients in illicit drugs. In patients being treated with buprenorphine for opioid addiction, it is important to screen for and manage common comorbid medical conditions and to anticipate known and potential drug interactions.
Pregnant Women and Neonates
The scant evidence available does not show any causal adverse effects on pregnancy or neonatal outcomes from buprenorphine treatment, but this evidence is from case series, not from controlled studies. Methadone is currently the standard of care in the United States for the treatment of opioid addiction in pregnant women. Pregnant women who present for treatment of opioid addiction should be referred to specialized services in methadone maintenance treatment programs. If such specialized services are refused by a patient or are unavailable in the community, maintenance treatment with buprenorphine may be considered as an alternative.
Adolescents/Young Adults
Buprenorphine can be a useful option for the treatment of adolescents with opioid addiction problems. The treatment of addiction in adolescents, however, is complicated by a number of medical, legal, and ethical considerations. Physicians intending to treat addiction in adolescents should be thoroughly familiar with the laws in their States regarding parental consent. Physicians who do not specialize in the treatment of opioid addiction should strongly consider consulting with, or referring adolescent patients to, addiction specialists. Additionally, State child protection agencies can be a valuable resource when determining the proper disposition for adolescent patients addicted to opioids.
Geriatric Patients
Literature on the use of buprenorphine in geriatric patients is extremely limited. Due to potential differences in rates of metabolism and absorption compared to younger individuals, care should be exercised in the use of buprenorphine in geriatric patients.
Patients With Significant Psychiatric Comorbidity
The presence and severity of comorbid psychiatric conditions must be assessed prior to initiating buprenorphine treatment, and a determination made whether referral to specialized behavioral health services is necessary. The psychiatric disorders most commonly encountered in patients addicted to opioids are other substance abuse disorders, depressive disorders, posttraumatic stress disorder, substance-induced psychiatric disorders, and antisocial and borderline personality disorder.
As with medical comorbidities, it is important to explore the medications used to treat the other psychiatric conditions. Assessing for drug interactions is a critical part of the process.
Polysubstance Abuse
Abuse of multiple drugs (polysubstance abuse) by individuals addicted to opioids is common. Pharmacotherapy with buprenorphine for opioid addiction will not necessarily have a beneficial effect on an individual’s use of other drugs. Care in the prescribing of buprenorphine for patients who abuse alcohol and for those who abuse sedative/hypnotic drugs (especially benzodiazepines) must be exercised because of the documented potential for fatal interactions.
Patients With Pain
Physicians may encounter particular complexities with regard to abuse and addiction in the use of opioids to treat patients with pain. Some patients move from needing prescription opioids for the treatment of pain to abusing them. Physicians concerned about this changing diagnostic picture now may legally use an opioid—buprenorphine—to help facilitate a controlled detoxification in order to manage the physical dependence of the patient who no longer has pain that requires an opioid, but who continues to take the opioid for its mood-altering effects.
Patients who need treatment for pain but not for addiction should be treated within the context of a medical or surgical setting. They should not be transferred to an opioid maintenance treatment program simply because they have become physically dependent on prescribed opioids in the course of medical treatment.
Patients who are being treated for addiction also may experience pain due to illness or injury unrelated to drug use. Pain in patients receiving buprenorphine treatment for opioid addiction should be treated initially with nonopioid analgesics when appropriate.
Patients maintained on buprenorphine whose acute pain is not relieved by nonopioid medications should receive the usual aggressive pain management, which may include the use of short-acting opioid pain relievers. While patients are taking opioid pain medications, the administration of buprenorphine generally should be discontinued. When restarting buprenorphine, to prevent acutely precipitating withdrawal, administration generally should not begin until sufficient time has elapsed for the opioid pain medication to have cleared from the patient’s system, as demonstrated by the onset of early withdrawal symptoms. Patients who are receiving long-acting opioids for chronic severe pain may not be good candidates for buprenorphine treatment because of the ceiling effect on buprenorphine’s analgesic properties.
Patients Recently Discharged From Controlled Environments
A number of issues should be considered in determining the most appropriate treatment modalities for patients with addiction who are recently released from controlled environments (e.g., prison). Intensive buprenorphine monitoring activities are required, and treating physicians may be called upon to verify and explain treatment regimens (e.g., to parole and probation officers); to document patient compliance; and to interact with the legal system, employers, and others. If an OTP alternative is available, physicians should determine if any patient factors preclude referral.
Healthcare Professionals Who Are Addicted to Opioids
There is a substantial problem of addiction to prescription opioids among physicians and other health professionals, especially within certain specialties. Prescription opioid addiction in health professionals should be viewed as an occupational hazard of the practice of medicine. Health professionals with substance abuse disorders often require specialized, extended care.
