1 Considerations in Medication Assisted Treatment of Opiate Dependence AOAAM OMED Education Program Sunday, October 7, 2012 Stephen A. Wyatt, D.O. Addiction Psychiatrist Middlesex Hospital Middletown, Connecticut
2 Objectives Review the development, science and prescribing policies of the currently available medications for the treatment of opiate dependence. Understand the factors important in the decision of which treatment would be indicated. Understand the factors associated with the initiation of a treatment for opiate dependence.
3 Current Treatments Medically assisted withdrawal and abstinence. Methadone maintenance Naltrexone: oral and injectable Buprenorphine/naloxone
4 Fatal Poisonings in France - Decreases with Availability of Opiate Treatment Source:Carrieri PM, 2006, Clin Infect Dis, 43: S , data from Emmanueli, et al.
5 Historical Review The 1914 Harrison was a commerce act restricting the sales of narcotics, it excluded physician treating patients In 1919 when the Harrison Act was upheld by the Supreme Court it excluded the treatment of opiate dependence: not considered a disease. No longer was it legal for physicians to prescribe opiates maintaining opiate dependence or for the treatment of the disease. Medically assisted withdrawal of opiates and abstinence was the only legal treatment. The historical records identify the relapsing nature of this disease. Hunt and Odoroff 1962, Duvall et al. 1963
6 Historical Review As the death rate of heroin injection patients continued to rise in the late 50 s and early 60 s, with a concurrent rise in associated crime, there was growing support for the establishment of opiate maintenance programs. There was an increase in Federal funding for research into treating these patients. In 1962 Vincent Dole, MD received a grant to study the feasibility of opiate maintenance treatment. In1964 Marie Nyswander, MD, psychiatrist with experience in treating addicted patients joined the research team. Methadone was eventually selected as the most efficacious opiate for maintenance treatment.
7 Historical Review The Comprehensive Drug Abuse Prevention and Control Act of 1970 was a Nixon initiative in the evolution of the war on drugs. However, included was a Dept. of Health, Education, and Welfare authorization to improve drug prevention and treatment. This included, under the direction of Jerome Jaffe, MD a federal effort to widen the availability of opiate maintenance programs.
8 Historical Review The next approved medication for Opiate dependence was naltrexone approved in As an opiate antagonist it blocks the opiate receptor significantly changing the patient response to the administration of an opiate. The lack of compliance and less reduction in craving are thought to be the prominent problems associated with poor efficacy of the oral product. A sustained release form was determined to have an adequate safety profile and to be effective by the FDA in 2010.
9 Historical Review With the establishment of DATA 2000 another treatment option was made available. This act of congress established that any class III, IV, V controlled substance with FDA approval for opiate dependence treatment could be prescribed by a qualified physician. This opened the door to buprenorphine. Resulting in availability of office based opiate treatment with an agonist medication. This further broadened the available of maintenance treatment.
10 Medication Assisted Treatment of Opiate Dependence METHADONE
11 Neurobiology: Methadone blocks the euphoric and sedating effects of other opiates; reduces the craving for other opiates relieves symptoms associated with withdrawal from opiates; does not cause euphoria or intoxication itself (with stable dosing), thus allowing a person to work and participate near normal in society; Has a long half life and is excreted slowly allowing for once a day dosing. CDC 2002
12 Methadone Treatment Methadone maintenance treatment, a program in which addicted individuals receive daily doses of methadone. Multi-component treatment program Abstinence of other drugs of abuse including alcohol Resocialization Sober supports Vocational training Coordination of healthcare HIV Hepititis C Pregnancy
13 Methadone Treatment Identified benefits include: reduced or stopped use of injection drugs; Reduced risk of acquiring or transmitting diseases such as HIV, hepatitis B or C, bacterial infections, endocarditis, soft tissue infections, thrombophlebitis, tuberculosis, and STDs; possible reduction in sexual risk taking reduced risk of overdose reduced mortality death rate of opiatedependent individuals in MMT is 30 percent that of those not in MMT; Improved Social Status reduced criminal activity; improved family stability improved employment potential; improved pregnancy outcomes. CDC 2002
14 Methadone Treatment Drawbacks Physical dependence, possibly strengthening neurobiologicaladaptation to opiate dependence. Initial daily administration at a licensed methadone treatment center Early mild to moderate opiate like effects; e.g. sedation, reduction in cognitive awareness Long term maintenance effects on hormonal adaptations; reduction in testosterone, menstruation, calcium metabolism Drug/Drug interactions Neonatal abstinence syndrome
15 Methadone Formulation Methadone for Pain or Addiction Methadone for outpatient pain treatment is in tablet form. 410,000 patients in third quarter of 2006 Methadone used in managing opioid dependence is usually liquid or wafer 260,000 patients in March, 2006 SAMHSA, N-SSATS 2007 Report
16 Percent of methadone Mentions Methadone Formulations reported RADARS System (Rocky Mountain Poison and Drug Center) Drug Diversion Opioid Treatment Program
17 Medication Assisted Treatment of Opiate Dependence NALTREXONE
18 Neurobiology: Naltrexone Naltrexone, a opiate antagonist. Attaches to the opiate receptor without activation. PET studies that a single 50 mg dose of naltrexone in a naive subject results in a 90% blockade of mu receptors at 24 hours. At 48 hours it s about 72%, and even at 96 hours some blockade is still present. No physical dependence Possible reduction in opiate craving through a combination of; blockade of the opiate receptor effecting endorphin activation and dopamine activation of the nucleus accumbens or pleasure center in the brain. Total opiate blockade reducing initial consideration of opiate use.
19 Naltrexone: Treatment Naltrexone has great potential as a therapeutic drug in assisting patients opiate treatment, Oral However the oral administration failed because primarily due to poor compliance. Extended Release (XR) Injectable has antagonist effects that last many weeks. the XR-NTX formulation currently available results in blood levels of 1-2 nanograms per milliliter (ng/ml) can provide adequate blockade for four to five weeks. compliance, remains a problem but is less problematic
20 Naltrexone Oral vs. Injection
21 Naltrexone Treatment Drawbacks Patients needs to have completed the withdrawal process prior to being started on naltrexone, Otherwise precipitated withdrawal will occur. following the injection formulation it is likely to be more intense on day 2 than day 1 May elevate liver transaminases Patients cannot be on opiate pain medication. If injected may have injection site inflammation (particularly obese patients)
22 Naltrexone Adverse effects If reinitiating opiates patient may be at increased risk due to loss of tolerance and possible upregulation. Some evidence of up-regulation of receptors in patients on naltrexone, possible increased risk of overdose deaths. At this point there is only evidence of this in rats. One study in humans was negative but this remains a concern. Vitally important to tell patients who have stopped taking naltrexone that if they do go back to using heroin, starting with anything more than a very small dose might result in death.
23 Medication Assisted Treatment of Opiate Dependence BUPRENORPHINE
24 Neurobiology: Buprenorphine Partial opiate agonist High affinity Slow dissociation Displaces other opiates including heroin Improved safety profile due to reduction in potential respiratory depression
25 Buprenorphine Treatment Approved for office based treatment Allows for normalization of treatment in the primary care or behavioral health care practices. Allows for wider availability of agonist treatment Reduces potential for overdose Once a day administration Minimal drug interaction Relative blocking of other opiates Significant reduction in craving Improved reentry into normal socialization
26 Buprenorphine Treatment Drawbacks Physical dependence, possible strengthening of the opiate dependence. Diversion for sustained opiate dependence and non-dependent abuse May reduces the drive to put in place relapse prevention behaviors due to the pharmacologic reduction in the drive to use other opiates. There is evidence of both hormonal adaptation and neonatal abstinence syndrome though less than that seen in the Methadone treated patient.
27 Medication Assisted Treatment of Opiate Dependence TREATMENT SELECTION
28 Treatment Selection Logistical considerations Access to a methadone treatment center has been a major limitation to this form of treatment Buprenorphine has limited availability due to limited access to a waivered physician, though private office availability has improved treatment access in rural areas in particular. Physician access to assistance with drug counseling Need for detoxification of opiates prior to the administration of naltrexone.
29 Treatment Selection There is significant overlap in the indications of one form of therapy over another. Patients may have a strong bias to one form of treatment over another. Honoring this may improve compliance and effectiveness. Physician knowledge and level of comfort will also be a consideration.
30 Treatment Selection Patients co-occurring medical or psychiatric problems should be considered. Poly substance abuse may need the daily oversight of MMT Mental health problems - availability of buprenorphine in medical/behavioral health specialty clinics Pregnancy - The opportunity for the patient to be treated in an established methadone maintenance pregnancy program should be a strongly considered. However, buprenorphine is gaining greater evidence of reducing both days of NAS and morphine dose following delivery.
31 Treatment Selection Methadone Access to care sometimes easier than others and sometimes not Patient in need of greater supervision Greater concerns of diversion. Limited social supports available Polysubstance abuse or dependence Possibly those with higher daily dose of opiate use prior to treatment however this is now in dispute. Concurrent chronic pain
32 Treatment Selection Naltrexone Patient currently abstinent with history of frequent relapse, opiate craving Recently incarcerated Recently detoxified from opiate maintenance treatment Not anticipating surgical treatment or pain requiring opiate treatment. Physician not waivered to use schedule III drug for office based treatment. Patient with evidence of being moderately compliant with treatment. The injectable form can be coupled to strong contingencies improving compliance and outcomes.
33 Treatment Selection Buprenorphine Access to waivered physician Access to relapse prevention treatment Possible lower level of opiate use though this is in dispute. Opportunity for coordination with other services both medical and psychiatric. The evidence of a reduction in drug-drug interaction with buprenorphine over methadone should be considered in the HIV pos. population. Moderate level of social supports available. Concurrent chronic pain
34 Treatment Selection Cost Comparison of medications vs. no medication of costs for medications, inpatient, outpatient, and pharmacy costs, 29% lower for patients who received a medication for opioid dependence versus patients treated without medication. Injectable sustained release naltrexone had fewer opioid-related and non opioid-related hospitalizations than patients receiving oral medications. Total healthcare costs were not significantly different between oral or injectable naltrexone and buprenorphine, and were 49% lower than those for methadone. This in part was a reflection on the increase co-morbidity seen in the Methadone population. Baser, AJ of Managed Care, 2011
35 Medically Assisted Opiate Treatment Abstinence remains an option particularly in the young low level dependent patient. However: There is strong evidence of improved outcomes with medication assisted treatment Patients should be made aware of their options Treatment providers should be aware of these medications to better educate patients and make appropriate treatment recommendations.
36 Conclusion There are yet clear answers to what is the best opiate treatment for a specific patient. In the end it is between the doctor and patient to determine the best fit.
Considerations in Medication Assisted Treatment of Opiate Dependence Stephen A. Wyatt, D.O. Dept. of Psychiatry Middlesex Hospital Middletown, CT Disclosures Speaker Panels- None Grant recipient - SAMHSA
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