Use of Buprenorphine for the office-based treatment of opioid addiction

Medication-assisted treatment of opiate addiction has received growing interest within the past decade. In fact, following the 2002 FDA approval of the use of buprenorphine for the treatment of opiate addiction, accreditation oversight for office-based opioid treatment has been transferred to the Department of Health and Human Services to facilitate implementation of such programs. There is now evidence to support that this accreditation process has improved access to quality care and, relevant to this information brief, integration of narcotic abuse/addiction treatment into traditional medical practice.¹

Why integrate such treatment into traditional medical practice? It is no mystery that coincident with the recognition of the importance of, and legitimate availability of narcotics for the treatment of pain, a clinically significant percentage of “normal” patients will go on to develop physiologic dependence and habits of misuse. Opiate addiction (ie, compulsive use despite harm) within the chronic pain population is somewhere around 2.8%² whereas the prevalence of nonmedical use of prescription drugs in the general population is roughly 0.8% (2002 survey).³ The unresolved question is whether this prevalence discrepancy is attributable to prescribing practices or is the consequence of “addictive personalities” that are potentiated by the availability of narcotics. Of note, the National Comorbidity Study (1994) estimated that 72% of individuals with a drug use disorder met diagnostic criteria for at least one other psychiatric condition.⁴ Thus, on the one hand narcotic addiction may be “blamed” on the medical system that itself is dependent on the use of these drugs for patient care, while on the other hand it may be the psychiatrically compromised patient who is to “blame” for their addiction. Regardless of where responsibility lies—and clearly it shifts with political currents—it seems reasonable that in medical practices where the use of narcotics are a mainstay of treatment, medication management will ideally include the availability of options for treating and managing inevitable opioid addiction. Hence emergence of national interest in the establishment of office-based treatment programs within traditional medical practice.

This brief summarizes information reported in the Center for Substance Abuse Treatment’s Clinical guidelines for the use of buprenorphine in the treatment of opioid addiction.^5,6 Information is distilled with the intention of providing a quickly digestible abstract of the rationale and practice of office-based opioid treatment using buprenorphine with the intention of guiding physicians’ consideration of the use of this treatment modality. Buprenorphine is a Schedule III, partial µ (opioid) receptor agonist with high binding affinity. Accordingly, it provides long lasting positive opioid effects while blocking opioid full agonists from exerting effects. That is, the use of buprenorphine is an effective treatment for opioid addiction because it provides legitimate analgesic effects, satiates cravings and, most importantly, blocks full opioid binding thereby eliminating escalation of narcotic effects with increased opioid use. It is important to note that buprenorphine is metabolized by the same pathway (cytochrome P450) as benzodiazepines and other sedatives, thus the risk of drug-drug interactions should be carefully considered for patients using or misusing these other drugs

Sublingual buprenorphine has been released under the trade name Subutex (Reckitt Benckiser Pharmaceuticals, Inc.⁷). The FDA has also approved release of a sublingual buprenorphine-naloxone combination therapy called Suboxone (same manufacturer). Naloxone is a strong µ-receptor antagonist that elicits sudden opioid withdrawal effects when administered intravenously. Thus, Suboxone is intended as a suitable opioid medication for individuals at risk for intravenous abuse. Treatment protocol typically consists of an induction phase during which Suboxone is administered in lieu of the observed treatment, with further doses (with tapering) as necessary. Frequent patient contact (ie. once weekly with tapering to bi-weekly) is recommended during the stabilization phase—the period following induction and absence of withdrawal effects—during which dosing adjustments, that may include switching to Subutex, are made. Following this the maintenance phase should emphasize addressing the psychosocial issues associated with the addictive behavior. The use of buprenorphine to taper off long acting opiates should be considered only for patients with evidence of medical and psychosocial stability. Thus, pre-treatment psychosocial evaluation is important. All phases of treatment should be in conjunction with treatment and management by a behavioral health practitioner and participation in a self-help (ie. support) group.

Physicians considering providing office-based treatment for opioid addiction will need to obtain a DATA 2000 waiver. To do so, a notice of intent to dispense/prescribe this treatment must be submitted to SAMHSA (available on line at the SAMHSA Web site⁸). Additionally, the physician must either have completed 8 hours of training in the treatment of opioid addiction or have certain other qualifications, such as the availability of providing patients with necessary concurrent psychosocial services.

1. Miller NS, Brady KT. Addictive disorders. Psychiatr Clin N Am. 27:xi-xviii, 2004.

2. Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshelman S, et al. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 51(1):8-19, 1994.

3. Manlandro, JJ. Buprenorphine for office-based treatment of patients with opioid addiction. JAOA, 105(6); S8-13, 2005.

4. Center for Substance Abuse Treatment. Clinical guidelines for the use of buprenorphine in the treatment of opioid addiction. Treatment Improvement Protocol (TIP Series 40). DHS Publication No. (SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2004.

Available at: http://buprenorphine.samhsa.gov/Bup%20Guidelines.pdf.

5. Krantz MJ and Mehler PS. Treating opioid dependence. Growing implications for primary care. Arch Intern Med 164:277-288, 2004.

6. Cowan DT, Wilson-Barnett J, Griffiths P, Allan, LG. A survey of chronic noncancer pain patients prescribed opioid analgesics. Pain Med, 4(4):340-351, 2003.

7. Product sheet available at: http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htmv

8. U.S. Department of Health and Human Services. Buprenorphine. Substance Abuse and Mental Health Services Administration. Accessed 2/7/2006.

Available at: http://buprenorphine.samhsa.gov/index.html