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Data demonstrate buprenorphine's effectiveness

February 1, 2011
by Erik W. Gunderson, MD and Adam J. Gordon, MD, MPH, FACP, FASAM
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Erik W. Gunderson, MD
Erik W. Gunderson, MD

We read with great interest Steven R. Scanlan, MD's article “Suboxone: concerns behind the miracle” (November/December 2010 issue), and we are writing to elaborate on several points and to review detoxification and maintenance treatment evidence to expand upon his anecdotal experience.

Opioid dependence remains largely untreated nationally; the expansion of office-based opioid treatment (OBOT) with buprenorphine is needed to address the treatment gap and to minimize associated morbidity and mortality when the disease is left untreated. In the office model, clinicians have opportunities to present patients with various treatment options that include use of non-pharmacotherapy, pharmacotherapy using buprenorphine and buprenorphine/naloxone (hereafter collectively termed “buprenorphine”), and referral to specialty professionals and services, including methadone maintenance therapy.

Mutual treatment planning often involves a decision whether to initiate buprenorphine maintenance treatment or to use the medication as a means of detoxification from the misused opioid. In his article, Dr. Scanlan advocates the use of detoxification primarily over a three-to-four week period to avoid numerous complications of maintenance in which “one addiction may be traded for another.”

We are concerned that the view equating buprenorphine maintenance with buprenorphine addiction reflects a common misconception about diagnostic criteria, and is unsupported by scientific evidence. Physical dependence on a substance is neither necessary nor sufficient for a DSM-IV substance dependence diagnosis, which is used interchangeably with addiction. Although buprenorphine-maintained patients on a stable long-term dose have physical dependence, including withdrawal with abrupt cessation, a lack of compulsive and uncontrolled problematic use precludes a buprenorphine-specific addiction diagnosis in these individuals.

Voluminous data

An extensive and growing body of research supports that positive long-term patient- and system-level outcomes can be achieved in primary care and other outpatient settings with buprenorphine maintenance treatment-even for traditionally vulnerable patient populations such as those who have HIV or who are homeless.1,2,3,4

OBOT with buprenorphine improves treatment engagement (roughly 50 to 60 percent retention at six months) and reduces cravings, illicit opioid use and mortality.4,5,6,7,8,9 Furthermore, long-term methadone maintenance therapy has a long history of evidence for successful patient outcomes; long-term OBOT with buprenorphine is an analogous treatment paradigm.

Although detoxification with buprenorphine may be more effective than non-opioid based detoxification approaches,10 the clinical effectiveness of buprenorphine detoxification appears less than that of buprenorphine maintenance. In a recent National Institutes of Health (NIH)-sponsored multi-site trial comparing buprenorphine-tapering schedules that overlap with Dr. Scanlan's approach, patients were tapered over seven or 28 days after a four-week period of stabilization.11 Approximately 85 percent in each group were actively using illicit opioids after the taper completed, in follow-up at one and three months. In contrast, an evaluation of long-term, primary care buprenorphine maintenance found a 9 percent opioid-positive urine toxicology during years two to five of follow-up (101 out of 1,106 samples).4 Patients received monthly brief physician counseling to promote abstinence, self-help involvement and functional improvement.

Prescriptive detoxification (four-week taper) in OBOT with buprenorphine will minimize provider-patient individualization of treatment and be contrary to the intention of federal legislation allowing OBOT.

Addressing bias

Despite the demonstrated benefits of buprenorphine maintenance treatment, many in the substance abuse treatment community may continue to view agonist maintenance as not being in “recovery.” Although recovery is variably defined,12 maintenance treatment when coupled with standard-of-care psychosocial treatment is capable of producing long-term sustained remission to alleviate the lifelong struggle for many individuals.

We agree that buprenorphine alone is not a “miracle cure” but rather a means of providing enough stabilization so that the patient may participate in the rehabilitative process. Non-pharmacotherapy and pharmacotherapy should be offered to all patients with opioid dependence.

We too are concerned about so-called “script docs” collecting monthly out-of-pocket cash fees for 5- to 10-minute refill visits without patient engagement in ancillary care. Such practice is largely outside the norm, with most prescribers either offering psychosocial treatment on-site or utilizing outside referral,13 consistent with national guidelines.14 We are equally concerned about a “revolving door” of detoxification in which patients cycle in and out of acute care for repeated detoxifications. In addition to likely limited cost-effectiveness, the approach puts patients at risk for overdose during relapse due to the decreased physical dependence occurring at the end of a taper.