Office-based treatment of opioid addiction has been unavailable in the United States since the early 1900s. Thus, most U.S. physicians today have little or no experience in the management of opioid addiction. As a consequence, physicians often treat substance-related disorders (e.g., infectious diseases) without having the resources to treat the concurrent substance-use disorder itself. With the introduction of buprenorphine, office-based physicians now will have the ability to treat both the complications of opioid addiction and opioid addiction itself. (For articles on managing opioid -dependent patients in the office setting, please see (Fiellin et al. 2001; Fiellin and O'Connor 2002; O'Connor et al. 1996, 1998)

Physicians who use buprenorphine to treat opioid addiction must consider the entire process of treatment, from induction, through stabilization, and then maintenance. At each stage of the process, many different factors must be considered if the physician is to provide comprehensive and maximally effective opioid addiction care. Physicians should conduct a comprehensive assessment to understand the nature of an individual's addiction problem, especially with regard to the primary type of opioid abused. Before initiating buprenorphine treatment, physicians should obtain a signed release of information (see Title 42, Part 2 of the Code of Federal Regulations [42 C.F.R. Part 2]) from patients who are currently enrolled in Opioid Treatment Programs (OTPs) or other programs (42 C.F.R. Part 2 2001). This section provides detailed protocols on the use of buprenorphine for the treatment of opioid addiction. The section begins with a discussion of some general issues regarding treatment with buprenorphine.

Buprenorphine Monotherapy and Combination Buprenorphine/Naloxone Treatment

The  consensus  panel  recommends  that  the  buprenorphine/ naloxone  combination be used for induction treatment (and for stabilization and maintenance) for most patients.

 However, pregnant women who are determined to be appropriate candidates for buprenorphine treatment should be inducted and maintained on buprenorphine monotherapy.

In addition, patients who desire to change from long-acting opioids (methadone ) to buprenorphine should be inducted using buprenorphine monotherapy.*

If the buprenorphine monotherapy formulation is elected for induction treatment, it is recommended that patients who are not pregnant be switched to the buprenorphine/naloxone combination form as early in treatment as possible to minimize the possibility of diversion of Subutex to abuse via the injection route.

When   the  buprenorphine  monotherapy formulation is used for induction, it is recommended that it be used for no more than 2 days before switching to the buprenorphine/naloxone combination formulation (for patients who are not pregnant).

 If buprenorphine alone is to be used for extended periods, the number of doses to be prescribed should be limited, and the use of the monotherapy formulation should be justified in the medical record.

Although controlled trials have not compared buprenorphine monotherapy to the buprenorphine/naloxone combination for induction, clinical experience in office-based trials conducted by the National Institute on Drug Abuse (NIDA) has demonstrated that physicians were comfortable starting patients on either the monotherapy formulation or the combination formulation and did not report adverse events when patients began directly on combination treatment.

Physicians will need to find their own comfort level with the induction protocols, but the consensus panel sees no contraindication to the use of the buprenorphine/naloxone combination in the initiation of buprenorphine treatment, except as noted above.

Must read for those considering Suboxone Pharmacotherapy...  

Opioid Withdrawal Syndrome With Buprenorphine Induction

Because buprenorphine (and particularly buprenorphine/  naloxone)can precipitate an opioid withdrawal syndrome if administered to a patient who is opioid dependent and whose receptors are currently occupied by opioids, a patient should no longer be intoxicated or have any residual opioid effect from his or her last dose of opioid before receiving a first dose of buprenorphine.

Due to this required abstinence before initiating  buprenorphine treatment, it is likely that patients will feel that they are experiencing the early stages of withdrawal when they present for buprenorphine induction treatment, unless they are on maintenance treatment with a long-acting opioid agonist (methadone). If a patient has early symptoms of withdrawal, then the opioid receptors are unlikely to be occupied fully; precipitated withdrawal from administration of buprenorphine will be avoided, and the efficacy of buprenorphine in alleviating withdrawal symptoms can be assessed more easily.

Withdrawal symptoms can occur if either too much or too little buprenorphine is administered (spontaneous withdrawal if too little buprenorphine is given, precipitated withdrawal if buprenorphine is administered while the opioid receptors are occupied to a high degree by an opioid agonist). Therefore, physicians must be careful when timing initiation of buprenorphine induction.

Each patient's history and concerns must be considered carefully, and patient counseling about potential side effects from buprenorphine overdosing (especially in combination with benzodiazepines) or underdosing (a reemergence of opioid craving)must be emphasized. Before undertaking buprenorphine treatment of opioid addiction, physicians should be familiar with the signs, symptoms, and time course of the opioid withdrawal syndrome.

Method of Administration

Buprenorphine sublingual tablets should be placed under the tongue until they are dissolved. For doses requiring the use of more than two tablets, patients should either place all the tablets at once or alternatively, if they cannot fit in more than two tablets comfortably, place two tablets at a time under the tongue. Either way, the tablets should be held under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the medication. Dissolution rates vary, but, on average, the sublingual tablets should dissolve in approximately 5-10 minutes.

How To Take

Suboxone enters the bloodstream under the tongue.

Treatment Approach

There are two general approaches to the medication-assisted treatment of opioid addiction:

 (1)  Opioid Maintenance Treatment
 (2) Medically Supervised Withdrawal (detoxification) with either Opioid (methadone) or Nonopioid (clonidine) Medications.  

 Because opioid-assisted maintenance and medically supervised withdrawal treatments have not been available outside the OTP setting, many patients may not be aware that these forms of treatment are now available in new clinical settings. Thus, a discussion with patients of all available treatment options is essential.

For many patients, it may be inappropriate to decide arbitrarily on the length of treatment at initial evaluation. It is more likely that patients will need to be started in treatment within a flexible time frame that responds to the progress and needs of the patient. For example, in one report of rapid-term opioid detoxification using buprenorphine, it was noted that 25 percent of patients initially requesting detoxification subsequently switched to maintenance treatment within the 10 -day study (Vignau 1998).

 Thus, as treatment progresses, it may become a more appropriate time to assess the duration of various aspects of treatment, including medications, counseling therapies, and self-help groups. Therefore, it is important to assess initially, and to reassess periodically, a patient's motivation for treatment, as well as his or her willingness to engage in appropriate counseling and/or a structured rehabilitation program.  

References: (1) Clinical  Guidelines  For  The  Use  Of  Buprenorphine In The Treatment Of Opioid Addiction (TIP 40) Chapter 4
                    (2) http://www.suboxone.com

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