The requested information is provided in Portable Document Format (PDF). To view and print this document you'll need to install a copy of the free Adobe® Acrobat® Reader®. If you already have Adobe Acrobat Reader installed click "View PDF" below. If you need the Acrobat Reader you can download it from the Adobe Acrobat Reader Download page.
As always, your information will not be sold or shared with anyone. See our privacy policy for more information.
NOTE: This study is only open to patients not currently under the care of a physician for opioid dependence and are seeking a treatment provider.
Please call 1-866-455-8876 between 9:00 AM to 7:30 PM EST to get more information.
The SUBOXONE Treatment Walk-through presents a basic overview of office-based treatment for opioid dependence.
Inevitably, the protocols described here will be adapted to fit the individual needs and strengths of each physician's practice.
Similarly, the treatment forms and handouts included here are offered as examples, with the assumption that they, too, will be customized to reflect the needs of each individual practice.
Physicians interested in more detailed treatment information, including steps for preparing the practice to treat opioid dependence, additional forms, handouts, and resources are encouraged to visit the SUBOXONE Practice Management Tool Kit.
The clinical pathway for office-based treatment of opioid dependence with SUBOXONE can be broken down into 6 phases:
Pretreatment Screening
Intake
Induction
Stabilization
Maintenance
Medically Supervised Withdrawal
Note: While intake and induction are, strictly speaking, 2 distinct phases of treatment, in practice, both phases may occur within a single office visit.
Pretreatment Screening
The goal of pretreatment screening is to determine whether office-based treatment is the best course of action for a particular patient.
Pretreatment screening usually consists of a brief interview conducted either over the phone or in person.
Pretreatment Screening form [PDF–Size: 29KB]
Patients who are accepted for treatment (ie, whose needs are suited to an office-based treatment regimen) are scheduled for their intake. (Physicians may prefer to perform intake and induction during the same visit.)
New patients are also sent a series of forms and handouts referred to here as the pretreatment paperwork.
Pretreatment paperwork generally consists of the following, but may be customized to meet your practice needs:The main benefit of pretreatment paperwork is its potential for helping treatment proceed more smoothly for everyone: Completed forms facilitate prompt care, while the patient handouts are a convenient reference tool and help to manage treatment expectations and adherence.
Intake
The primary objective of the intake is to establish a medical record of a patient's suitability for office-based treatment of opioid dependence.
Presence of psychiatric comorbidity should not exclude patients from SUBOXONE treatment.1 Untreated or inadequately treated psychiatric disorders can interfere with the effective treatment of substance abuse.1 Alternatively, substance abuse can mimic, exacerbate, or precipitate psychiatric symptoms and disorders.1 Assessment is fundamental to determining whether symptoms reflect primary psychiatric disorder or substance-induced condition.1
During the intake, urine drug screening should be performed to confirm opioid use. Urine tests also can be used to screen for polydrug abuse, as well as for use of substances that might interfere with or complicate treatment.1,2
Blood work is recommended prior to treatment in order to:A physical exam is also recommended; however, it may be performed at another time or by another physician, as the treating physician feels is appropriate.
The intake is also a good time to discuss the pros and cons of SUBOXONE treatment, patients' treatment expectations, and any other issues or questions related to treatment.
The intake and induction phases of treatment may take place during the same office visit.
Induction
The goal of induction is to safely suppress opioid withdrawal as rapidly as possible with adequate doses of SUBOXONE.
When scheduling a patient's first induction visit, it is important to remind him or her to arrive experiencing mild-to-moderate opioid withdrawal symptoms (otherwise, treatment may have to be postponed).
The induction phase usually averages 2 to 5 days. To avoid any possible delay of treatment, physicians frequently begin induction immediately following the intake, rather than scheduling the induction for a separate visit.
Although the details will vary between practices, the first induction visit generally proceeds as follows:
| 1. | Patient's withdrawal symptoms are assessed and documented.
|
| 2. | The first dose of SUBOXONE is administered. |
| 3. | 1 to 2 hours later, the patient's withdrawal symptoms are reassessed, and a second dose of SUBOXONE is administered if needed. |
Induction dosing
SUBOXONE should be dosed to levels that produce the desired clinical effect: suppressing the withdrawal symptoms and cravings that trigger opioid use.
For in-depth information about appropriate dosing during induction and all other phases of treatment, please see the SUBOXONE Dosing Guide.
Under-dosing during induction does not offer any clinical benefits. In fact, under-dosing may actually increase the risk of treatment failure because it fails to adequately control patients' withdrawal symptoms and cravings.3-6
Patients whose symptoms and cravings are not suppressed may try to self-medicate with opioids or other substances. Patients who test positive for supplemental drug use may need their SUBOXONE dose titrated upward.
When considering the safety of higher doses during induction, physicians should be aware that SUBOXONE can reduce respiratory rate. However, because buprenorphine is a partial opioid agonist, when taken alone, it exhibits a "ceiling effect" on respiratory depression—unlike full opioid agonists with which respiratory depression continues increasing as the dose increases.7 This "ceiling effect" means SUBOXONE by itself is unlikely to cause death in the event of an overdose.
Despite the favorable safety profile of buprenorphine, caution is advised regarding its concomitant use with other sedatives, such as benzodiazepines, due to the additive effects exerted by buprenorphine.8 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.9,10
Upon leaving the office
Some physicians prefer to prescribe enough SUBOXONE so that patients can take additional doses at home as needed.
During the next phase, stabilization, the patient's SUBOXONE dose is "fine-tuned." The objective is to find the minimum dose necessary to hold the patient in treatment, suppress opioid withdrawal effects, and suppress other opioid use (this dose can be anywhere from 4 to 24 mg per day, depending on the individual).
Doses are progressively adjusted in increments or decrements of 2 to 4 mg. After each dose adjustment, 3 to 7 days should be allowed for steady-state blood levels to be achieved, before evaluating the need for further dose changes.
Therapy Progress Report [PDF–Size: 28KB]
Opiate Withdrawal Record (Induction Form) [PDF–Size: 46KB]
Some physicians prefer the Opiate Withdrawal Record (Induction Form) because it facilitates tracking the patient's response to medication over time.
Psychosocial counseling usually begins during stabilization.
The length of the stabilization phase will vary depending on the needs of the patient.
Some patients elect to proceed directly from stabilization to Medically Supervised Withdrawal. However, unless there is a compelling reason to avoid all opioid use, longer-term buprenorphine treatment (ie, maintenance) is usually recommended because of the higher likelihood for treatment success.1
SUBOXONE therapy and psychosocial counseling continue. Treatment compliance and progress are regularly monitored, and may entail urine screening tests and other laboratory evaluations as appropriate.
As the patient moves further along in his or her treatment and his or her condition improves, the need for frequent monitoring generally abates.
The duration of the maintenance phase depends on the individual needs of the patient and can range from weeks to years.
Medically Supervised Withdrawal
Medically supervised withdrawal from SUBOXONE should occur only when the patient and physician agree that to do so would be beneficial.
The patient's SUBOXONE dose should be slowly tapered at a rate that both physician and patient consider acceptable. It is not uncommon for patients to want to taper more, rather than less, quickly, so helping patients set realistic goals is important from the outset.
Patients should be prepared for the possibility of mild, transitory withdrawal symptoms, which may include reduced energy, reduced appetite, irritability, or insomnia.
It is also important for patients to understand that they can halt the medical withdrawal at any time and return to a higher dose.
Some patients will ask to proceed directly from stabilization to medically supervised withdrawal. However, unless there is a compelling reason to discontinue SUBOXONE quickly (eg, travel), Maintenance is usually encouraged, because it is associated with a higher likelihood of treatment success.1
Although no standard dosing protocol exists for medically supervised withdrawal, sample protocols are provided in the SUBOXONE Dosing Guide.
| 1. | Center for Substance Abuse Treatment (CSAT). Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration, 2004. |
| 2. | National Library of Medicine. National Institutes of Health. Medical Encyclopedia: Toxicology screen. Medline Plus website. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/003578.htm. Accessed April 13, 2005. |
| 3. | Uehlinger C, Deglon J-J, Livoti S, Petitjean S, Waldvogel D, Ladewig D. Comparison of buprenorphine and methadone in the treatment of opioid dependence. Euro Addict Res. 1998;4:13-18. |
| 4. | Fischer G, Gombas W, Eder H, et al. Buprenorphine versus methadone maintenance for the treatment of opioid dependence. Addiction. 1999;94:1337-1347. |
| 5. | 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. |
| 6. | Amass L, Kamien JB, Mikulich SK. Efficacy of daily and alternate-day dosing regimens with the combination buprenorphine-naloxone tablet. Drug Alcohol Depend. 2000;58:143-152. |
| 7. | 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. |
| 8. | Buprenex Prescribing Information. Richmond, Va: Reckitt Benckiser Pharmaceuticals, Inc; July 2001. |
| 9. | Kintz P. Deaths involving buprenorphine: a compendium of French cases. Forensic Sci Int. 2001;121:65-69. |
| 10. | Kintz P. A new series of 13 buprenorphine-related deaths. Clin Biochem. 2002;35:513-516. |
