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| 1. | What Is Opioid Dependence? | ||
| A: |
Opioid dependence has often been described as a brain disease with a behavioral component.* Studies of brain chemistry have led to the understanding that opioid dependence is a biological brain disease that drives drug-seeking behavioral patterns that are neurologically wired to survival.1 The physical reality of withdrawal and cravings compounds the psychosocial aspect of the disease and causes a strong need to repeat the experience.
Long-term fundamental changes to the structure and function of the brain often compel people to continue to misuse opioids, despite the harm they can cause.2 *World Health Organization and the National Institute on Drug Abuse.
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| 2. | How Prevalent Is Opioid Dependence? Is It Likely To Be in My Practice? | ||
| A: |
The NSDUH estimated that 1.6 million people were dependent on opioid analgesics or heroin in 2003.3 Of that number, 0.2 million were estimated to be dependent on heroin but other studies have estimated the proportion to be 4 to 5 times that.4,5 Because opioid dependence does not discriminate, it affects people from all socioeconomic strata,5 and you are likely to encounter it in your practice.
See Data on Heroin and Oxycodone Lifetime Users [PDF–Size: 29KB]. Opioid dependence is an under treated disease: more than 75% of people in the United States with opioid dependence never seek treatment.6 Often, part of the reason people are reluctant to seek treatment is due to the societal stigma attached to this disease and, many healthcare professionals are not currently screening for opioid dependence during patient interviews.7 |
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| 3. | How Do I Screen for Opioid Dependence? | ||
| A: |
Identification of opioid-dependent patients will most likely result from a combination of information, including a physical exam, patient interview, and standardized screening.8 Helpful screening tools include the following questionnaires (modified for opioid dependence):
Tips for Success
Healthcare professionals report that opioid-dependent patients respond most favorably to interviewing techniques that are presented in a nonjudgmental tone. Demonstrating your knowledge about substance abuse will often elicit a positive patient response. Also, patients are more likely to be honest with you about their opioid use when they believe they will receive the treatment they need.
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| 4. | How Do I Assess Treatment Readiness? | ||
| A: |
As patients progress through the various stages of confronting their opioid dependence, there are several opportunities for you to intervene.9 By using a tool such as the Stages Of Change, Readiness, And Treatment Eagerness Scale (SOCRATES 8D), which is designed to assess readiness for change in drug abusers, you can assess a patient's level of motivation and discuss the treatment possibilities that match his/her level of motivation.
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| 5. | How Do I Educate Patients About Opioid Dependence? | ||
| A: |
One of the first things you can do to help is to inform the patient that opioid dependence is a medical condition with a behavioral component. It's important to tell them that it is a disease, not a symptom of a moral failing or being a bad person. Learning that opioid dependence is a medical condition can help elevate the patient's self-esteem and help the patient understand the appropriateness of taking medication for the illness.
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| 6. | How Can I Help Manage the Patient's Expectations? | ||
| A: | After assessing the patient's readiness for change, you can help by assisting him/her in creating a treatment plan. Prior to starting SUBOXONE treatment, it is important to establish guidelines specifically tailored to the patient that define clear boundaries and goals for a successful treatment regimen, including specified times for scheduled appointments, urine toxicology testing, and the consequences of not adhering to mutual agreements. It's also important to encourage the patient to begin psychosocial counseling. | ||
| 7. | What Is SUBOXONE? | ||
| A: |
SUBOXONE is a prescription medication used to treat opioid dependence. SUBOXONE is composed of buprenorphine and naloxone. Buprenorphine is a partial opioid agonist that suppresses withdrawal symptoms and reduces cravings in order to increase treatment retention and reduce illicit opioid use. Naloxone is an opioid antagonist, which is present to discourage misuse or diversion. If SUBOXONE is crushed and either injected or snorted, the naloxone component will precipitate withdrawal in a person dependent on a full opioid agonist. When SUBOXONE is taken as directed, very little—if any—naloxone is absorbed sublingually.
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| 8. | What Is the Clinical Evidence for SUBOXONE Use? | ||
| A: |
SUBOXONE has been shown to suppress withdrawal symptoms, decrease cravings, improve treatment retention, and reduce illicit opioid use. SUBOXONE maintenance therapy, when combined with psychosocial counseling, has also been shown to enhance patient success. In two studies of buprenorphine, one reporting 6-month results, treatment retention rates ranged from 42%10 to 72%.11 The 6-month study11 showed significant improvements from baseline in:
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| 9. | How Does SUBOXONE Work? | ||
| A: |
The buprenorphine in SUBOXONE binds to mu-opioid receptors in the brain, and it has a higher affinity than full agonists (eg, methadone, heroin, oxycodone, hydrocodone, morphine). When a person begins SUBOXONE therapy, he/she should be in a mild-to-moderate state of opioid withdrawal. As the buprenorphine attaches to the opioid receptors, withdrawal symptoms are relieved and the patient begins to feel better. In a dose-dependent manner, buprenorphine firmly attaches to most receptor sites and blocks other opioids from attaching. Buprenorphine also has a long duration of action, allowing for once-daily dosing.
See Mechanism of Action. |
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| 10. | How Is Buprenorphine Different From Other Opioids? | ||
| A: |
Buprenorphine, a partial opioid agonist, produces limited euphoria compared with full opioid agonists,12 while suppressing withdrawal symptoms and reducing cravings, which helps to reinforce treatment adherence. Also, respiratory depression is limited with SUBOXONE because of its characteristic "ceiling effect." This effect provides a margin of safety when SUBOXONE is taken alone versus a full opioid agonist.12-14 At higher doses of SUBOXONE, the risk of fatal respiratory depression does not continue to increase as it does with full opioid agonists. However, intravenous use of buprenorphine, usually in combination with benzodiazepines or other central nervous system (CNS) depressants, has been associated with significant respiratory depression and death. (See Additional Safety Information here[j1])
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| 11. | Is SUBOXONE Treatment Just Trading One Dependence for Another? | ||
| A: |
All opioids can cause physical dependence; however, the appropriate use of SUBOXONE allows medical management of opioid dependence, similar to the way you would manage diabetes or other chronic diseases. In addition, since withdrawal symptoms experienced with SUBOXONE are milder than those of a full opioid agonist, the dosage should be more easily tapered off when the patient no longer requires pharmacotherapy.
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| 12. | What Are the Stages of SUBOXONE Therapy? | ||
| A: |
There are 4 major stages of SUBOXONE therapy:
1) Induction Of course, patient education and preparation are important during all four phases of treatment, but they are particularly important when guiding patients through the induction stage. It is critical that the patient understands the need to arrive for induction while in a mild-to-moderate state of withdrawal.6 By discussing a patient's specific physical withdrawal symptoms during the initial intake interview process, you can readily identify them when the patient returns to the office for induction. Tools like the Clinical Opiate Withdrawal Scale (COWS) [PDF–Size: 46KB] can be helpful when assessing a patient's level of withdrawal. If a full opioid agonist is still active in the patient's system when starting induction, SUBOXONE may precipitate severe withdrawal symptoms as buprenorphine displaces the full agonist from the mu-receptors. However, when the patient is in mild-to-moderate withdrawal, SUBOXONE will bind to the available mu-receptors, thereby suppressing withdrawal symptoms and reducing drug cravings. Definition of "Precipitated Withdrawal"
Precipitated withdrawal is indicated by withdrawal symptoms that result when one drug displaces another drug from the receptor, and the drug has no or less effect than the drug it has displaced. When SUBOXONE is given before a patient has begun to withdraw from the misused drug, withdrawal symptoms may occur more rapidly and intensely.
During induction, it is also important to educate the patient on how to correctly administer SUBOXONE sublingually. Buprenorphine enters the bloodstream through the veins under the tongue. A mirror can be used to show the patient the correct tablet placement. SUBOXONE tablets dissolve within 5 to 10 minutes. The tablet should not be chewed or swallowed and should be allowed to dissolve completely. You should encourage the patient not to talk, eat, or drink until the tablet is completely dissolved. After the medication begins to take effect (usually within 30 to 60 minutes), you can assess withdrawal symptoms again and, if necessary, administer another dose of SUBOXONE. The patient should be instructed to return to the office as scheduled (usually within 24 hours) for continued evaluation of clinical response. SUBOXONE Sublingual Administration
The stabilization period provides the time to find the best SUBOXONE dose that keeps withdrawal symptoms and cravings under control to retain the patient in treatment. The duration of SUBOXONE maintenance can range from weeks to years, based on the individual's needs. The frequency of visits to a physician are also individualized, depending on the patient's progress. Medical withdrawal can be initiated when you, the rest of the healthcare team, and the patient agree that the patient is ready to cease SUBOXONE treatment. During this period, SUBOXONE dosing can be tapered slowly while you continue to assess the patient's needs and clinical response, in order to decrease the likelihood of relapse. In terms of the patient's psychosocial support, evaluation and therapeutic intervention by a counselor are important for a successful outcome; therefore, you should recommend counseling throughout the duration of SUBOXONE treatment and beyond, as needed. |
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| 13. | What Is the Most Effective Dose of SUBOXONE? | ||
| A: |
Dosing for SUBOXONE is determined according to individual need. As a nurse, you are uniquely qualified to closely observe and assess the behavior and attitude of each patient. This assessment can help you and the physician determine the proper stabilization dose. During the stabilization phase, SUBOXONE dosage should be progressively adjusted in increments of 2 mg to 4 mg, up to a target daily dose between 16 mg and 24 mg.
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| 14. | How Long Should a Patient Continue SUBOXONE Treatment? | ||
| A: |
Because each patient is unique, length of treatment is tailored to the specific needs of the individual and may range from weeks to years. When the therapeutic team (consisting of you, the doctor, and the counselor) collaboratively agrees with the patient that he/she is ready and able to stop SUBOXONE treatment, a schedule for tapering the dose can be devised.
See Dose Reduction Rates [PDF–Size: 14KB]. |
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| 15. | How Does Relapse Play Into Opioid Dependence Treatment? | ||
| A: |
Opioid dependence is a chronic, relapsing brain disease.1 As with other chronic medical conditions, patients may relapse and become nonadherent to treatment for a period of time. Relapse should not be considered a treatment failure and does not necessarily mean that a patient has abandoned a commitment to change. Open communication is crucial; and, if a patient discloses that he/she has relapsed, it may actually reflect a renewed commitment to his/her treatment plan. Longer-term maintenance treatment has been associated with lower relapse rates.
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| 16. | What Can I Expect in My Practice? | ||
| A: |
SUBOXONE treatment is no different than any other therapy; a learning curve exists. Confidence with SUBOXONE use comes from understanding the benefits of this therapy, especially as it is combined with psychosocial counseling. Your confidence will also evolve from increased experience with the process of effectively managing opioid-dependent patients with SUBOXONE.
Some helpful tools to help you integrate SUBOXONE therapy into your practice include: SUBOXONE Practice Management Tool Kit (PMTK) Patient Education Materials Diagnostic and Evaluation Tools |
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| 17. | Where Can I Find Additional Information Related to the Treatment of Opioid Dependence? | ||
| A: |
Additional information about SUBOXONE and opioid dependence is available at this website. You may also call the SUBOXONE Help Line at 1-877-SUBOXONE (1-877-782-6966).
The Substance Abuse and Mental Health Services Administration (SAMHSA) has also provided information on Treatment Improvement Protocols (TIPs - Visit http://treatment.org/Externals/tips.html)
The Center for Substance Abuse Treatment (CSAT), part of SAMHSA, oversees opioid-dependence treatment. |
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| 18. | What Are the Risks to Consider? | ||
| A: |
SUBOXONE (buprenorphine HCl/naloxone HCl dihydrate, sublingual tablets) (CIII) is indicated only for the treatment of opioid dependence.
Intravenous use of buprenorphine, usually in combination with benzodiazepines or other CNS depressants, 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. The most commonly reported side effects for SUBOXONE include: headache (36% vs 22% placebo), withdrawal syndrome (25% vs 37%) placebo), pain (22% vs 19% placebo), nausea (15% vs 11% placebo), insomnia (14% vs 16 5 placebo) and sweating (14% vs 10% placebo). See Prescribing Information for a full list. |
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| 1. | Kosten TR, George TP. The neurobiology of opioid dependence: implications for treatment. NIDA Science & Practice Perspectives. 2002;13-20. |
| 2. | Leshner AI. Addiction is a brain disease, and it matters. Science. 1997;278:45-47. |
| 3. | Substance Abuse and Mental Health Services Administration (SAMHSA). Results From the 2003 National Survey on Drug Use and Health: National Findings. Rockville, Md: Department of Health and Human Services (DHHS), SAMHSA, Office of Applied Studies; 2004. NSDUH Series H-25, DHHS Publication No. SMA 04-3964. |
| 4. | Stancliff S. Buprenorphine and the treatment of opioid addiction. The PRN Notebook. 2004;9:28-32. |
| 5. | SAMHSA. Nonmedical Oxycodone Users: A Comparison With Heroin Users. The National Survey on Drug Use and Health Report. January 21, 2005. Available at: oas.samhsa.gov/2k4/oxycodoneH/oxycodoneH.htm. Accessed May 30, 2006. |
| 6. | Center for Substance Abuse Treatment (CSAT). Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Rockville, Md: SAMHSA; 2004. A Treatment Improvement Protocol TIP 40, DHHS Publication No. SMA 04-3939. |
| 7. | The National Center on Addiction and Substance Abuse (CASA) at Columbia University. Missed Opportunity: National Survey of Primary Care Physicians and Patients on Substance Abuse. New York, NY: The National Center on Addiction and Substance Abuse at Columbia University; April 2000. |
| 8. | Detection and diagnosis of opioid dependence [CME course]. Available at: www1.addictioncme.com. Accessed April 12, 2006. |
| 9. | Miller WR, Tonigan JS. Assessing drinker's motivations for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). Psychology of Addictive Behaviors. 1996;10:81-89. |
| 10. | Johnson RE, Jaffe JH, Fudala PJ. A controlled trial of buprenorphine treatment for opioid dependence. JAMA. 1992;267:2750-2755. |
| 11. | Lavignasse P, Lowenstein W, Batel P, et al. Economic and social effects of high-dose buprenorphine substitution therapy: six-month results. Ann Med Interne (Paris). 2002;153(suppl 3):1S20-1S26. |
| 12. | Walsh SL, Eissenberg T. The clinical pharmacology of buprenorphine: extrapolating from the laboratory to the clinic. Drug Alcohol Depend. 2003;70(suppl 2):S13-S27. |
| 13. | Mattick RP, Ali R, White JM, O'Brien S, Wolk S, Danz C. Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients. Addiction. 2003;98:441-452. |
| 14. | Walsh SL, Preston KL, Stitzer ML, Cone EJ, Bigelow GE. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994;55:569-580. |
