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| 1. | What Is Opioid Dependence? |
| A: |
Opioid dependence has been described by the World Health Organization and the National Institute on Drug Abuse as a brain disease with a behavioral disorder. 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.1
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| 2. | What Happens Neurobiologically? |
| A: |
Opioids attach to the mu-opioid receptors in brain cells (neurons), activating the brain's reward system, which is responsible in part for the biochemical processes that promote basic life functions and survival. The feelings created by the brain's reward system are those of pleasure. Misuse of opioids is associated with intense feelings of pleasure. Researchers have discovered that opioids cause long-term changes in the brain that can cause people to have cravings years after they have stopped taking drugs.1 Clinical studies have also shown that the chemical activity in the brains of opioid-dependent individuals is significantly different than that of healthy volunteers who are non-users.2
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| 3. | How Do Physicians Diagnose Opioid Dependence? |
| A: |
Physicians use the DSM-IV-TR criteria for substance dependence and substance abuse to diagnose opioid dependence. Physicians evaluate a cluster of behaviors and physiologic effects that occurs in an opioid-dependent person within a specific time frame. Prior to making a diagnosis, the physician interviews the patient to obtain a history and conducts a physical examination. Physicians new to the field of opioid dependence can learn more about opioid-dependent patients when a collaborative system is in place; ie, one that includes counseling professionals.
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| 4. | What Is the Significance of the Drug Addiction Treatment Act of 2000? |
| A: |
Physicians certified under DATA 2000 are allowed to prescribe Schedule III, IV, or V narcotic medications (opioids) approved for the treatment of opioid dependence in a private-practice setting. This has opened up treatment options to many individuals who may have been intimidated by other treatment settings and prefer the confidentiality and convenience of a private-practice setting. Currently, SUBOXONE and SUBUTEX (buprenorphine HCl sublingual tablets) (CIII) are the only medications approved to treat opioid dependence under DATA 2000.
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| 5. | What Is SUBOXONE? |
| A: |
SUBOXONE is composed of buprenorphine and naloxone. Buprenorphine is a partial opioid agonist that blocks other opioids from attaching to brain receptors. SUBOXONE also contains naloxone to discourage misuse or diversion. Therefore, if SUBOXONE is crushed and either injected or snorted, the naloxone component will cause precipitated withdrawal in a person dependent on an opioid agonist.
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| 6. | What Are the Differences Between SUBOXONE and SUBUTEX®? |
| A: |
SUBOXONE contains both buprenorphine and naloxone (see above); SUBUTEX is composed of buprenorphine only. SUBUTEX is recommended for use in limited situations—induction, naloxone sensitivity, and where exposure to naloxone may cause additional risk.
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| 7. | How Is SUBOXONE Different From Other Opioids? |
| A: |
SUBOXONE, a partial opioid agonist that produces limited euphoria and milder withdrawal symptoms compared with full agonists (ie, methadone, heroin, and morphine),3 provides sufficient effects to reinforce treatment adherence. Respiratory depression, which may be lethal, is limited with SUBOXONE when used alone due to a "ceiling effect" whereby increasing the dose does not increase the effect proportionally. This ceiling effect, characteristic of partial opioid agonists, provides a margin of safety with SUBOXONE versus full opioid agonists.3-5
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. |
| 8. | Is Treatment With SUBOXONE Just Trading One Dependence for Another? |
| A: |
All opioids can cause physical dependence; however, the appropriate use of SUBOXONE under physician supervision allows an opioid-dependent patient to have the disease managed medically. Together, the physician and counselor help control the bio-psycho-social aspects of the patient's illness. In addition, the physiological withdrawal symptoms experienced with SUBOXONE are milder than those of a full opioid agonist. This helps retain patients in treatment, including counseling. The decision to taper the SUBOXONE dose is determined by the therapeutic team (generally made up of the doctor and counselor) and the patient. Realistic goals for dosage reduction and medical withdrawal should be established.
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| 9. | How Does SUBOXONE Work? |
| A: |
SUBOXONE binds to mu-opioid receptors in the brain, and it has a stronger chemical attraction and bond than most full agonists (eg, methadone, heroin, oxycodone, hydrocodone, and morphine). When a person begins SUBOXONE therapy, he/she should be in a mild-to-moderate state of withdrawal from the misused opioid. Then, as the other opioid leaves the person's system, buprenorphine attaches to the opioid receptors, withdrawal symptoms are relieved, and the patient begins to feel better. At adequate maintenance doses, buprenorphine occupies most receptors and, in a dose-dependent manner, blocks other opioids from attaching. Buprenorphine has a long duration of action; it does not wear off quickly, allowing for once-daily dosing. Buprenorphine has also been shown to reduce cravings, reduce illicit drug use, and improve treatment retention.
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| 10. | What Is the Clinical Evidence for SUBOXONE Use? |
| A: |
It has been shown that psychosocial counseling combined with SUBOXONE maintenance enhances patient success. In two studies, one reporting 6-month results, treatment retention rates ranged from 42%6 to 72%.7 The 6-month study7 showed significant improvements from baseline in: illicit drug use (excluding alcohol), injection drug use—related risk, employment, and personal relationships. Maintenance therapy with SUBOXONE may afford opioid-dependent patients the time to seek and sustain psychosocial counseling, thus relearning the skills required for successful opioid-free living.
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| 11. | What Are the Stages of SUBOXONE Therapy? |
| A: |
There are several stages of SUBOXONE therapy: induction, stabilization, maintenance, and medical withdrawal. Counseling should be integrated into all phases of SUBOXONE treatment.
During induction, the patient should be in a state of mild-to-moderate withdrawal. The healthcare professional, usually the physician, assesses the patient's withdrawal symptoms and administers the first dose of SUBOXONE. After the medication begins to take effect (within 30 minutes to 1 hour), the patient's symptoms are reassessed and, if necessary, a second dose may be given. The patient should return to the doctor's office as scheduled (usually within 24 hours) for continued evaluation of clinical response. The stabilization period provides the time to find the best individualized SUBOXONE dose that keeps withdrawal symptoms and cravings under control and retains the patient in treatment. As a counselor, you may be able to assess whether pharmacotherapy is achieving these goals and recommend adjustments. The duration of SUBOXONE maintenance (medically assisted therapy) can range from weeks to years, based on individual patient needs. The frequency of regular visits to a physician are also individualized, depending on the patient's progress. In terms of psychosocial adjustment, therapeutic intervention and evaluation by a counselor are important to the successful outcomes of many patients; therefore, counseling is recommended throughout SUBOXONE therapy. At the appropriate time during the course of therapy, the decision to taper the SUBOXONE dose is determined by the therapeutic team (generally made up of the doctor and counselor) and the patient. |
| 12. | What Other Benefits of SUBOXONE Therapy Can Help Meet Your Patient's Needs? |
| A: |
In-office treatment provides patients with the comfort of privacy, which breaks down self-imposed barriers to seeking treatment, and helps to reduce the fear of being stigmatized. Maintenance therapy with SUBOXONE may afford patients the time to manage the physical distractions that prevent them from seeking and continuing psychosocial counseling. There is evidence that psychosocial counseling used in concert with SUBOXONE treatment enhances treatment retention.6,7 In two studies, one reporting 6-month results,7 treatment retention rates ranged from 42%6 to 72%.7 Furthermore, comprehensive treatment may help reduce a patient's vulnerability to triggers and relapse.8
The flexibility of take-home SUBOXONE treatment may eliminate the need for daily visits to a doctor's office, thus decreasing restrictions in the patient's life: work hours are uninterrupted, business travel is unrestricted, family events may be attended, and leisure travel may be planned. |
| 13. | What Options Can an Experienced Counseling Professional Offer a Physician? |
| A: |
Some physicians new to the arena of opioid dependence may not have the breadth of psychosocial experience that certain counselors may have. Your knowledge of evidence-based counseling options that best match the personality traits and circumstances of an opioid-dependent individual can assist the physician in making the most effective referral. There are many types of effective counseling options. Some you may want to consider are:
Cognitive Behavioral Therapy for Relapse Prevention9 Individualized Drug Counseling9 Motivational Enhancement Therapy9 Supportive-Expressive Psychotherapy9 |
| 14. | What Is the Important Safety Information for SUBOXONE Use? |
| A: |
As with other medications in this class, 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% placebo), and sweating (14% vs 10% placebo). See Product Information for a full list.
Intravenous use of buprenorphine, usually in combination with benzodiazepines or other CNS depressants, has been associated with significant depression and death. Please review the Important Safety Information that appears at the bottom of the screen. The full Prescribing Information may be accessed by clicking on the icon with that same name, which appears at the top of this section. |
| 15. | What Can Help My Patients Achieve the Best Results? |
| A: |
The successful collaboration of the counselor and physician to devise a treatment plan that combines pharmacotherapy and psychosocial counseling has made a positive impact on improved patient outcomes. Assisting opioid-dependent patients in finding a physician qualified to prescribe pharmacotherapy will encourage them to get medical help to manage their physical withdrawal symptoms and reduce cravings. In turn, physicians who have been trained and certified to prescribe SUBOXONE understand the importance of psychosocial counseling. Many physicians are prepared to collaborate with counselors so that patients can gain skills that will help them manage triggers and change their behavior, thus reducing illicit drug use. SUBOXONE therapy, in combination with psychosocial counseling, has been shown to suppress withdrawal symptoms, decrease cravings, improve treatment retention, and reduce illicit opioid use.
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| 16. | What Must Patients Know About Combined Use of SUBOXONE With Central Nervous System (CNS) Depressants? |
| A: |
Intravenous use of buprenorphine, usually in combination with benzodiazepines or other CNS depressants, has been associated with significant respiratory depression and death.
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| 17. | How Can I Find a Physician Certified to Treat With SUBOXONE in My Area? |
| A: |
To find a certified physician, access suboxone.com and click on the Physician Locator icon. Other options are:
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| 18. | Where Can I Find Additional Information Related to the Treatment of Opioid Dependence? |
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Additional information about SUBOXONE and opioid dependence is available at opioiddependence.com and on this website. You may also call the SUBOXONE Help Line at 1-877-782-6966. Other options are:
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| 1. | Leshner AI. Addiction is a brain disease, and it matters. Science. 1997;278:45-47. |
| 2. | Wang G-J, Volkow ND, Fowler JS, et al. Dopamine D2 receptor availability in opiate-dependent subjects before and after naloxone-precipitated withdrawal. Neuropsychopharmacology. 1997;16:174-182. |
| 3. | 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. |
| 4. | 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. |
| 5. | 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. |
| 6. | Johnson RE, Jaffe JH, Fudala PJ. A controlled trial of buprenorphine treatment for opioid dependence. JAMA. 1992;267:2750-2755. |
| 7. | 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. |
| 8. | Auriacombe M, Tignol J. Buprenorphine use in France: Quality of life and conditions for treatment success. Research and Clinical Forums. 1997;19:25-32. |
| 9. | National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Principles of Drug Addiction Treatment: A Research-Based Guide. US Government Printing Office; 1999. NIH Publication No. 99-4180. |