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Treating opioid dependence offers many medical and personal benefits to patients, their families, and society as a whole.1,2
Several forms of treatment are available, including drug-free psychosocial counseling in an inpatient or outpatient setting, 12-Step programs, opioid pharmacotherapy with methadone in specialized treatment or rehab centers, and certain specialized "rapid detox" approaches. Recently, the passage of the Drug Addiction Treatment Act of 2000 (DATA 2000) opened the door to a revolutionary treatment approach. DATA 2000 gave physicians the legal right to prescribe Schedule III-V medications for the treatment of opioid dependence outside a hospital or clinic setting, ie, within the privacy of their own offices. This office-based opioid treatment allows any physician who meets the qualification requirements listed by DATA 2000 to treat opioid dependence in an office setting just as she or he would treat other chronic diseases such as diabetes or depression. Pharmacological treatment for opioid dependence has not always been so accessible. The practice of prescribing one opioid to treat dependence on another opioid was the subject of much controversy. Additionally, office-based treatment of opioid dependence was illegal for most of the 20th century, and punishable with jail time.3 Unfortunately, the consequences of such tight scrutiny were limited treatment options and availability. Methadone At that time, researchers were beginning to see successful results with methadone used to treat heroin dependence. Early research showed that methadone had great promise to reduce heroin use and the associated criminal activity. Patients on methadone often recovered sufficiently to enter the workforce again with improved general health. Despite these successes, however, methadone as a treatment was highly stigmatized, and strong concerns about drug diversion, appropriate use, and potential harm to children were common among law enforcement officials, the general public, and advocates for drug-free treatment alternatives.3 Finally, in 1973, thanks to an effort led by the White House Action Office for Drug Abuse Prevention, the US Food and Drug Administration (FDA) approved methadone for the treatment of opioid dependence and made it available through special methadone clinics or rehab centers and hospital pharmacies.3 Even today, strict regulations governing methadone use are still in place. While the introduction of this treatment modality was a major step forward in the treatment of this disease, methadone may not be the most appropriate therapeutic option for certain patients. With limited exception, methadone must be administered in a drug treatment clinic, which means that patients are required to visit a clinic daily for their therapy. As a full opioid agonist, methadone can cause severe, even fatal, respiratory depression in nontolerant individuals. Physical withdrawal from methadone is reportedly very difficult.1 Furthermore, the drug itself is highly addictive—the DEA classifies methadone as a Schedule II narcotic requiring stringent control—and it possesses sufficient potential for abuse to have become a street drug of choice in some areas. LAAM Office-Based Opioid Treatment (OBOT) DATA 2000 represents the first time in more than 30 years that physicians have been able to treat opioid-dependent patients with prescription opioids in an office-based setting.1 The fact that any doctor, including general practitioners and primary care doctors, can become certified to treat opioid dependence with SUBOXONE has expanded patient access to treatment. As office-based treatment with SUBOXONE gains wider use, this intervention modality has the potential to expand treatment availability across the country, including rural areas and small towns. Buprenorphine Features unique to partial opioid agonists include the following:
Buprenorphine can reduce respiratory rate. However, because buprenorphine is a partial opioid agonist, when taken alone it exhibits a ceiling dose beyond which no greater effect is observed on physiologic or subjective measures.4 This "ceiling effect" on respiratory depression—unlike full opioid agonists with which respiratory depression continues increasing as the dose increases—means buprenorphine by itself is unlikely to cause death in the event of an overdose.4 Despite buprenorphine's favorable safety profile, caution is advised regarding its concomitant use with other sedatives, such as benzodiazepines, due to the additive effects exerted by buprenorphine.5 Inappropriate concomitant use (eg, higher doses than prescribed, parenteral administration) of psychotropics (especially benzodiazepines) and buprenorphine appears to be one of the risk factors for buprenorphine-related fatalities.6,7 The molecule naloxone, an opioid antagonist, is added to buprenorphine in the product SUBOXONE in order to deter abuse and diversion. When SUBOXONE is used as prescribed, the naloxone in the tablets should have no perceived effect,8 but if SUBOXONE is injected by an opioid-dependent person, then the naloxone precipitates withdrawal symptoms. The deterrent effect of naloxone should lower SUBOXONE's abuse potential. There is also a buprenorphine formulation called SUBUTEX, which does not contain naloxone. In the United States, SUBUTEX is prescribed for induction onto buprenorphine and for patients who are allergic to naloxone. SUBUTEX should not be routinely prescribed for at-home maintenance therapy. Phases of Pharmacotherapeutic Treatment
Back to Top SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate CIII sublingual tablets) is indicated for the treatment of opioid dependence. Buprenorphine, particularly when taken by the intravenous route, in combination with benzodiazepines or other CNS depressants (including alcohol) has been associated with significant respiratory depression and death. SUBOXONE has potential for abuse and produces dependence of the opioid type, with a milder withdrawal syndrome than full agonists. Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine. There are no adequate and well-controlled studies of SUBOXONE (a Category C medication) in pregnancy. Caution should be exercised when driving cars or operating machinery. Always store buprenorphine-containing medications safely and out of the reach and sight of children. Destroy any unused medication appropriately. The most commonly reported adverse events with SUBOXONE include: headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and constipation (12%, placebo 3%). Please see full Prescribing Information for a complete list. To report an adverse event caused by taking SUBOXONE, please call 1-877-782-6966 or e-mail pharmacovigilanceUS@reckittbenckiser.com. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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