Buprenorphine clinics: an integrated and multidisciplinary approach to treating opioid dependence.
Opioid dependence remains a very difficult problem facing the state of West Virginia, be it prescription opioids or heroin. Access to care for those struggling with opioid dependence continues to be problematic as well.
By the time most individuals with opioid dependence seek help from treatment providers, they have developed significant tolerance to opioids and soon go into withdrawal without using. Opioid withdrawal produces significant physical and psychological distress which fuels continued use. This cycle can continue for months to years, and individuals find themselves spending increasing time and resources looking for and using opioids. In the end, opioid dependent patients rarely get "high," but are often just using to "feel normal" and avoid withdrawal. They also find themselves facing a variety of stressors stemming from their use.
Any treatment plan enacted by a medical provider for an opioid dependent individual should be multifaceted, involving social, psychological and biological interventions.
With respect to opioid dependence, biological interventions are commonly referred to as medication assisted treatment (MAT).
Questions and Answers
What MAT options are there?
Prior to 2000, there were essentially two medication assisted treatments medical providers could offer to patients. They could either go on full agonist therapies such as methadone, or on full antagonists such as naltrexone. Both of these options had relative strengths and weaknesses.
A key change in legislation by Congress in 2000 attempted to address this problem. Better known as the Drug Addiction Treatment Act of 2000 (DATA 2000), the passage of this law allowed physicians to treat opioid dependent individuals from their office with FDA approved schedule III, IV and V medications. This can be done by notifying the Department of Health and Human Services (DHHS) through the Center for Substance Abuse Treatment (CSAT) of intent to treat by applying for and receiving a waiver of the special registration requirements defined in the Controlled Substance Act (CSA).
In late 2002, the FDA approved buprenorphine (schedule III) as an office based treatment for opioid dependence. It was made available to physicians who received the buprenorphine waiver, allowing them to begin treating opioid dependent patients from their office. Without the proper qualifications and waiver, a provider is in violation of the CSA.
How do I qualify?
There are a variety of ways to qualify for this waiver. They all involve showing some degree of familiarity, or expertise with respect to treating addiction, and with buprenorphine.
More detailed information can be found at the CSAT Buprenorphine Information Center. 866. BUP.CSAT or http:// buprenorphine.samhsa.gov
What is buprenorphine and how does it work?
It is an opioid that works as a partial agonist and has high affinity for opioid receptors. These properties allow it to act like several different medications rolled into one. It is not a full agonist like morphine, codeine, heroin, oxycodone, hydrocodone, fentanyl or methadone, nor is it a full antagonist like naloxone or naltrexone. It is technically referred to as a mixed agonist-antagonist due to the aforementioned properties. (1)
What does that mean?
At doses normally prescribed for opioid dependence, it acts as an agonist, occupying opioid receptors in a manner that prevents withdrawal, reduces cravings, and allows many patients to "feel normal." Methadone does this as well, but that is where the similarities end. Whereas increasing dosages of methadone increase the risk of respiratory depression, increasing doses of buprenorphine likely increases the risk of opioid withdrawal. With buprenorphine, there is a "ceiling effect". This occurs because buprenorphine begins to function as an antagonist at higher doses. It also acts as an opioid blocker, once an individual is at a steady state with respect to their buprenorphine dose. This effect is believed to occur because buprenorphine tightly binds to opioid receptors. Patients who relapse and use opioids while on buprenorphine often report feeling little or no effect when they use opioids. It is most commonly taken in a sublingual fashion, and it's long half life allows for once daily dosing. (1)
What is a normally prescribed dose?
An average maintenance buprenorphine dose for an opioid dependent individual ranges from 8-16 mg per day. (1)
Too good to be true?
Buprenorphine alone was found to have some abuse potential upon initial studies. Patients reported injecting the medication to get high. To combat this, a buprenorphine/ naloxone combination medication was developed. This combination is better known as Suboxone[R]. Naloxone only exerts an effect when injected, and is essentially inert when taken sublingually. Suboxone[R] has advantages over buprenorphine alone, when used to treat opioid dependence. (1)
A common question posed by care providers, patients and their families alike is "aren't you just trading one thing out for another?" There short answer is "yes you are" if that is all you do as a provider and neglect to implement a treatment plan focused on addiction, with psychological and social interventions. (2,3)
Unfortunately, addicts often encounter buprenorphine on the street that has been diverted. This may be their first impression of it. They often see other active addicts using the medication simply to keep from being sick or in withdrawal. Often times, they present to clinic partially detoxed with Suboxone[R] or with it in their system alongside other opioids.
Why provide more than just medication?
Pharmacotherapy alone is rarely sufficient for drug addiction. Treatment outcomes demonstrate a dose-response effect based on the level or amount of psychosocial treatment services that are provided. (3)
How best to provide more than just medication?
Use buprenorphine as part of an organized addiction treatment clinic.
What is a Buprenorphine Clinic?
It is a place where someone struggling with opioid dependence can go to get help from a biological, psychological and social standpoint, with the net result being an entry into recovery.
What is recovery?
This can be a charged term, with varied implications. For the purpose of this article and the sake of simplicity; it will be defined as sobriety from drugs and alcohol plus improvement in quality of life. (4)
What should a Buprenorphine Clinic consist of?
A Physician, Therapist, Medical Assistant and Case Manager functioning as a team.
The physician must apply for and be granted the waiver to prescribe buprenorphine. As mentioned earlier, this involves showing experience and knowledge with respect to treating addiction and using buprenorphine. There is more than one way to go about doing so. The physician is responsible for starting, stopping, adjusting the medication, and managing side effects. They should rely heavily upon the input from other members of the treatment team as decisions on when to start, stop and taper buprenorphine can be complicated.
A valuable tool available to all physicians comes by way of the West Virginia Board of Pharmacy and their Controlled Substances Monitoring Program. This can be applied for, and accessed online by going to www.wvbop.com. The program lists controlled substances filled at pharmacies in West Virginia, showing drug, strength, quantity, physician, pharmacy, and date filled.
A therapist will need to have some background in addiction, and provide the bulk of the psychological intervention. Therapy is best applied in both a group and individual setting. Therapists will also be able to assist with the assessment of new patients.
Case managers will help keep the clinic running smoothly by screening potential referrals, addressing issues that arise with respect to current patients, and managing patient flow. This person will answer many phone calls.
Medical assistants help administer screening tools and in the assessment of patients. The most important of which remains the urine drug screen. There are many different screens available that test for a wide range of substances with good sensitivities and specificities. Importantly, results should be obtained during the clinic visit. Since these results are qualitative, the ability to obtain confirmation via gas chromatography and mass spectrometry (GC/MS) should be available, and most screens offer the ability to do so. In addition to a quality screen, the treatment team must be sure to obtain specimens in a manner that is consistent and that reduces the risk of patients tampering with the sample, or providing samples that are not their own.
The team should encourage the key social intervention, including requirement of regular attendance at twelve-step facilitation meetings such as AA or NA. Patients should keep a log of meetings attended and provide it to the team. The team should also urge patients to seek a sponsor and begin working the steps. These meetings are available throughout West Virginia and can provide a key social support for those attempting to stay clean. Meeting times and places can easily be accessed online. (3)
Buprenorphine Clinic Contingencies?
It is important that patients are well educated regarding the rules and requirements of the clinic set forth by the treatment team. They should sign a contract that clearly spells this out. Typical contracts require things like safeguarding of medication, frequency of clinic attendance, honesty, regular attendance of AA/NA meetings and random drug screens. Rules set forth by the contract need to be strictly and uniformly adhered to. With respect to frequency of visits, patients should initially be seen weekly by the team until they stabilize in their recovery. We recommend they obtain a 12-step sponsor and that they are regularly attending meetings. In our clinic, four twelve step meetings per week are required.
What if more than a Buprenorphine Clinic is needed?
The Clinic is streamlined to treat individuals with opioid dependence. The treatment team needs to be quick to note who is struggling and refer them to the appropriate level of care. Some patients will need longer term treatment, or intensive outpatient treatment addressing more than just opioid dependence. Some will need inpatient detoxification. Some will need more of a dual diagnosis approach to address concurrent mental health issues.
How long to stay on the medication?
Buprenorphine is approved for maintenance and detoxification. It can be used for several days to years. Most patients will not want to remain on the medication forever, but will express much anxiety with respect to tapering off. The treatment team needs to involve the patient in this decision and try to look closely at the risks and benefits before a decision is made. A key component is how far a client has progressed with respect to their recovery. Currently, there is not a standard protocol for weaning off buprenorphine.
What if you are taking care of a patient on buprenorphine?
It's important to remind yourself of the properties of buprenorphine.
Patients are given cards to carry to show other clinicians in the event of questions. This is especially important when treating pain. In the event of acute or severe pain, larger than normally used amounts of opioids can override buprenorphine.
Patients on buprenorphine also may have to undergo elective procedures. Coordination between providers is key to avoid relapse or complications, especially with respect to perioperative pain management as patients may need to go off of buprenorphine for a short amount of time before and after the procedure.
What if you see a patient you think will benefit from buprenorphine?
The SAMHSA website has links to locate providers. Physicians should inquire whether a clinic has additional therapies integrated alongside the medication.
Explain what buprenorphine is, how it works, and why it is combined with naloxone.
Explain why it was approved to treat opioid dependence and how to qualify to be able to use it.
Explain how to integrate buprenorphine into a multidisciplinary treatment team.
Utilize resources to locate providers who use buprenorphine.
(1.) Rolley E. Johnson, Eric C. Strain, Leslie Amass, Buprenorphine: how to use it right, Drug and Alcohol Dependence, Volume 70, Issue 2, Supplement 1, Buprenorphine and Buprenorphine/Naloxone : A Guide For Clinicians, 21 May 2003, Pages S59-S77, ISSN 0376-8716, DOI: 10.1016/S0376-8716(03)00060-7. (http://www. sciencedirect.com/science/article/B6T63-489B3YX-1/2/5f19388448ad2c67e5781f05 7860919f)
(2.) Amato L, Minozzi S, Davoli M, Vecchi S, Ferri M, Mayet S. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD005031. DOI: 10.1002/14651858. CD005031.pub3
(3.) Center for Substance Abuse Treatment. 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.
(4.) Thomas McLellan, What is recovery? Revisiting the Betty Ford Institute Consensus Panel Definition: The Betty Ford Consensus Panel and Consultants, Journal of Substance Abuse Treatment, Volume 38, Issue 2, March 2010, Pages 200-201, ISSN 0740-5472, DOI: 10.1016/j. jsat.2009.11.002. (http://www. sciencedirect.com/science/article/B6T90-4XY4B3C-1/2/74928803e0b476d6a32054 2f7ec7cee5)
25. Buprenorphine is combined with naloxone to reduce abuse potential. True or False
26. In what year was buprenorphine approved by the FDA to treat opioid dependence?
27 . What term best describes buprenorphine's mechanism of action?
a. Full agonist
b. Full antagonist
c. Mixed agonist-antagonist
d. None of the above
Patrick J. Marshalek, MD
Chief Resident in Psychiatry, Department of
Behavioral Medicine and Psychiatry, West Virginia
Carl R. Sullivan, MD, FACP
Professor, Vice-Chair and Director,
Residency Training, Department of Behavorial Medicine
and Psychiatry, West Virginia University, Morgantown