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Topic 10: “Treatment Options for Opioid Substance Abuse” Comparative effectiveness of medication regimens, intensive counseling, and combined modalities for treatment of opioid substance abuse. Criteria Introduction Overview/ definition of topic Relevance to patient centered outcomes Burden on Society Recent incidence and prevalence in populations and sub populations Brief Description DESCRIPTION OF CONDITION Opioid dependence occurs when patients are unable to stop using opioids (substances derived from the opium poppy or synthetic versions such as morphine, heroin, and oxycodone). Dependence can be related to use of illicit or prescribed drugs. Opioid prescription painkillers were involved in almost 15,000 deaths in 2008. 1 TREATMENTS Medication Assisted Treatment (MAT) involves the use of drugs that are longer acting, but induce less euphoria. This treatment has been shown to be effective in randomized control trials and metaanalyses.25 Replacement medications include: o Methadone Used to reduce diversion, it is only available in Narcotic Treatment Programs subject to specific licensing and regulations (not available in doctor’s offices) o Buprenorphine Used to reduce diversion and available via doctor’s prescription as long as physician meets specific requirements to dispense Use is FDA approved only in combination with naloxone Naltrexone, though used more often for alcohol dependence, is prescribed for relapse prevention to block the effects of opioids. Counseling is also used to teach skills to reduce cravings, prevent relapse and address related issues (e.g., mental and physical health, socioeconomics, and relationships).4 Combination MAT and counseling/sober support groups are another option Fewer than 10% of people dependent on opioids in the U.S. receive MAT treatment4 due to lack of access. Detoxification programs are not covered in this brief.4 The most relevant patientcentered outcome is quality of life. New research that identified the most effective ways to allow access to treatments for opioid addiction, with minimal relapse rates, could drastically improve the quality of life for addicts as well as their families, employers, and society as a whole.6 PREVALENCE AND SUBPOPULATIONS About 4.5% of US adults (14.1 million) reported nonmedical use of prescription opioids in the past year in a national survey; of these, about 13% (1.84 million) met the criteria for opioid dependence. 7 Some subpopulations are at increased risk: PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options 27 Criteria Brief Description People with low incomes8 People on Medicaid (in Washington State, one study found 45% of people who died from prescription painkiller overdoses were enrolled in Medicaid) 9 o People with mental illness and/or addiction to other substances (e.g., alcohol) 8 o Residents of the Southwestern U.S. and the Appalachian region 1 INCIDENCE o o initiating use of nonmedical prescription pain relievers, but by 2011, this had risen to 11.1 million.10 Effects on patients’ quality of life, productivity, functional capacity, mortality, and use of health services QUALITY OF LIFE/FUNCTIONAL CAPACITY/MORTALITY A recent metaanalysis found that 32% of people using opioids for nonmedical reasons had comorbid mental health symptoms.11 o 17% had comorbid depression o 16% had comorbid anxiety o 48% reported chronic pain Patients with opioid addictions are generally unable to maintain employment and personal relationships.12 Opioidrelated fatalities have increased dramatically in past ten years; 13 in 2008, opioids contributed to approximately 5 out of 100,000 deaths in the U.S. 14 Opioid overdose is the second leading cause of accidental death in U.S. 4 USE OF HEALTH SERVICES/PRODUCTIVITY Recent study found that healthcare utilization costs in opioid users were >5 times higher than nonusers ($2138/month vs. $408/month) 15 Societal costs were estimated to be $55.7 billion in 2007. 12 o $25.6 billion from lost earnings from reduced productivity/early death o $25.0 billion from health care costs (medical/prescription costs) o $5.1 billion from criminal justice costs (prison/police costs) How strongly does the overall societal burden suggest that CER on alternative approaches to this problem should be given high priority? FACTORS IN FAVOR Moderate to high number of Americans affected (n=1.84 million) 7 Chronic/longterm condition High economic burden, especially for serious patient outcomes (e.g., overdose) 12 Many patients have chronic pain FACTOR AGAINST Even if most effective treatment methods identified, lack of access to treatment might limit use Social stigma against persons with substanceabuse problems Options for Addressing the Issue Based on recent Many (approximately 18) Cochrane reviews synthesize evidence for various treatments systematic reviews, for opioid addiction. what is known about Three Cochrane Systematic Reviews1618 and an American Society of Addiction the relative benefits Medicine19 consensus panel concluded psychosocial counseling in addition to and harms of pharmacological treatments is the most effective way to treat opioid dependence. available o Psychosocial counseling alone was not effective. 1618 management One systematic review found that buprenorphine can be used for maintenance PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options 28 Criteria options? What could new research contribute to achieving better patientcentered outcomes? Have recent innovations made research on this topic especially compelling? How widely does care now vary? Brief Description treatment due to its lower abuse potential,20 but three Cochrane reviews suggested it may be less effective than methadone delivered at adequate dosages;2,21,22 the National Institute for Health and Care Excellence (NICE) guidelines recommend use of methadone as a first choice. 23 A recent metaanalysis of 18 randomized control trials concluded that doses >60 mg/day and individualized doses of methadone are associated with better retention compared to doses <60 mg/day or fixeddose strategies.24 The U.S. Department of Veteran’s Affairs/U.S. Department of Defense and the World Federation of Societies of Biological Psychiatry recommend methadone or a combination of buprenorphine and naloxone as firstline treatment. 25,26 A Cochrane review found that heavy sedation upon commencement of naltrexone maintenance treatment does not confer additional benefits compared to light sedation and might lead to life threatening adverse effects and greater costs.27 Another recent Cochrane review suggested that prescribing heroin along with flexible doses of methadone could decrease heroin use among longterm, treatment refractory opioid users compared to methadone alone. 28 o Evidence shows heroin prescriptions might reduce involvement in criminal activity, incarceration, mortality, and increase retention in treatment programs.28 Two Cochrane reviews found insufficient evidence on effectiveness of detoxification and maintenance treatments for adolescents who were dependent on opioids.29,30 Three other Cochrane reviews found insufficient evidence regarding the effectiveness of sustainedrelease naltrexone, 31 oral naltrexone, 32 and oral morphine.33 Comparative effectiveness of longterm outcomes of MAT. Comparative effectiveness of longterm maintenance therapy plus different types of psychosocial therapy (e.g., cognitive behavioral therapy, 12step programs, group therapy, family therapy) Comparative effectiveness of different maintenance therapies in terms of treatment of noncancer chronic pain in patients with opioid addictions. Comparative effectiveness of different treatment plans among adolescents addicted to opioids. Patient preferences for alternative treatment strategies including site of care (i.e., clinic vs. doctors office) Use of clonidine offlabel (currently used to mitigate withdrawal symptoms) for maintenance therapy Because of high prevalence of relapse, most patients require many episodes of treatment or ongoing treatment Type of treatment depends on many factors, including prior treatment history, medical and /or mental health comorbidities, cooccurring alcohol and/or other drug use, PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options 29 Criteria What is the pace of other research on this topic as indicated by recent publications and ongoing trials? Brief Description socioeconomic status, and access to treatment. Care varies greatly and is dependent upon the availability of Narcotic Treatment Programs, insurance status, and other factors. Clinicaltrials.gov : NIH Reporter (search: opioid abuse): Search: Opioid abuse Projects: 494 Ongoing trials: 102 Publications: 156 Completed trials: 315 One ongoing study plans to present longterm outcomes (1.5, 2.5, and 3.5 years) comparing drug counseling plus buprenorphine to standard medical management CER that identified subpopulations that would benefit from certain treatment regimens would improve clinical decisionmaking. CER that improved access to treatment and reduced relapse rates would also provide valuable information that would impact clinical decisions. How likely is it that new CER on this topic would provide better information to guide clinical decision making? Potential for New Information to Improve Care and PatientCentered Outcomes What are the BARRIERS facilitators and Access to treatment is limited. barriers that would o Methadone, regulated by the Drug Enforcement Administration, is only available affect the in federal and statelicensed Narcotic Treatment Programs, so not available implementation of through general practitioners in the U.S. as it is in Canada and many other new findings in countries.4 practice? o Physicians who want to prescribe buprenorphine must meet requirements outlined in Drug Abuse Treatment Act of 2000 or take 8hour training course; also physicians are limited to 30 buprenorphine patients in their first year and 100 patients in subsequent years.34 Insurance coverage: o Medicare Part A pays for inpatient substance abuse care. o Medicare Part B pays for outpatient substance abuse treatment services, but methadone is not covered when delivered on an outpatient basis. FACILITATORS Under the Affordable Care Act, all health insurance plans sold on Health Insurance Exchanges or provided by Medicaid must include services for substance abuse. However, for states that are opting out of Medicaid expansion, people with incomes <133% of federal poverty level will not have access to treatment. Private insurance generally covers treatment. Medicaid generally covers treatment. In some counties, public health departments provide vouchers for entry into MAT programs. How likely is it that the results of new research on this topic would be implemented right Somewhat likely that new research would be implemented right away; however, the major issue is access to treatment Research on novel drug regimens or novel uses for existing drugs will take time to reach patients, given the need for FDA approval and the typical pace of diffusion for PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options 30 Criteria away? Brief Description pharmaceuticals. Research on improved access to care and retention in treatment would likely be readily implemented. Would new information New information from CER on opioid dependence would likely remain current for several from CER on this topic years. remain current for several years or would it be rendered obsolete quickly by subsequent studies? CER = comparative effectiveness research; FDA = U.S. Food and Drug Administration; MAT = medication assisted treatment; NICE = National Institute for Health and Care Excellence PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options 31 References for Topic 10: “Treatment Options for Opioid Substance Abuse” 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. Vital signs: overdoses of prescription opioid pain relieversUnited States, 19992008. MMWR Morb Mortal Wkly Rep. Nov 4 2011;60(43):14871492. Mattick R, Kimber J, Breen C, Davoli M. 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Slowrelease oral morphine as maintenance therapy for opioid dependence (Review). Cochrane Database Syst Rev. 2013(6). 34. Preda A. Opioid Abuse Treatment & Management. 2013. http://emedicine.medscape.com/article/287790treatment. Accessed November 12, 2013. PCORI Topic Brief: Assessment of Prevention, Diagnosis, and Treatment Options 33