Medication treatments for opioid use disorders

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1 Medication treatments for opioid use disorders Summary for counties JUDITH MARTIN, Medical Director of Substance Use Services, San Francisco Department of Public Health

2 Brief history of Methadone and Buprenorphine treatment 1965 Methadone maintenance is shown to be a good treatment for heroin addiction, allowing normal daily life with a single daily dose. The treatment spreads, partly supported because of returning Vietnam era veterans who had become dependent on heroin and opium in Southeast Asia. Regulations kept methadone treatment sequestered in specially licensed facilities, regulated by FDA and states. Treatment requirements include counseling and random testing, and limited takehome medication. Because of this historic high level of regulations and its isolation from mainstream mental health and addiction treatment, many physicians and mental health providers knew very little about it. Patients did well on the medication, but often complained about the level of supervision and rules. In addiction treatment circles there were polarizing debates about whether methadone maintenance was treatment or just another drug s and early 1990 s The HIV epidemic showed needle use to be a risk, and methadone maintenance was shown to reduce seroconversion, with risk lower for long-term treatment because of high relapse to IDU upon discharge. During this time methadone maintenance became well known as a useful tool among HIV specialists, and became more accepted. Advocacy groups and associations In the climate of stigma against medication treatment, the American Methadone Treatment Association, now American Association for the Treatment of Opioid Dependence, or AATOD, was formed, of which COMP is the California chapter. The AATOD conference, held every 18 months, is a prestigious multidisciplinary conference for anyone working in methadone clinics to learn about new research and best practices. One preconference at AATOD is the course for clinicians, which trains doctors and nurses about the medical side of methadone maintenance clinic work. There are very limited training opportunities for those who work in OTPs. AATOD had done advocacy work for evidence-based treatment of heroin addiction. (A consumer and peer advocacy group also formed, the National Association of Methadone Advocates or NAMA, which runs advocacy trainings at AATOD conferences). 1996, Sopke v Smolley resulted in Medi-Cal coverage of methadone maintenance under DMC. Prior to that time, limited slots for only two years of treatment had been available to patients on disability with Medi-Cal benefits. Before this change, many patients in California were paying for methadone maintenance out of their monthly SSI check. 1996, the Federal Government decided that addiction was not a disabling condition with respect to SSI benefits. About 75% of SSI beneficiaries who prior to that had received SSI due to disabling heroin addiction had significant dual diagnosis mental health problems, and were re-classified as mental health disability beneficiaries under SSI.

3 1997 the Institute of Medicine put out a report on optimal treatment for heroin addiction, citing methadone maintenance as showing significantly better outcomes than other options, and calling for increased access to maintenance pharmacotherapy, including its use outside of methadone clinics many pilots were done of medical maintenance continuation of methadone medication in rehabilitated patients who no longer needed counseling in primary care clinics, with various models. These pilots largely resulted in the 30-day take-home within 42CFR, see below Title 9 regulation package completed in California. It has not been revised, although specific updates on certain points have been issued milestone change in Federal methadone regulations, removing oversight from FDA to CSAT/SAMHSA, and new 42 CFR part 8 governs methadone clinics, now called opioid treatment programs or OTPs. Requirement of accreditation by an accepted accrediting body (JCAHO or CARF in California) replaces direct federal inspections (DEA still inspects the medication storage and dispensing and reconciliation). Aside from accreditation instead of direct monitoring, another big change was extending the take-home maximum, from 6 days to 29 days, but still requiring at least one observed dose per month California bill calling for methadone satellite clinics or Officebased sites passes. Regulations have yet to be written buprenorphine approved by FDA and labeled by DEA. This allowed office-based use of sublingual buprenorphine by specially trained physicians working outside methadone clinics, for example in primary care or mental health clinics. Buprenorphine was also added as an agonist treatment medication in 42 CFR federal regulations. California added it to the allowed medication list, but did not further regulate it or cover it under Drug Medi-Cal. Eventually it was added as a Medi-Cal pharmacy benefit for opioid dependence diagnosis , huge national surge in use and mis-use of opioid pain relievers, with parallel increase in addiction and deaths from prescription opioids, prompting the CDC to label poisoning deaths to be an epidemic. (Rise in deaths related to benzodiazepines and related sedative-hypnotics also seen, and about 30% of opioid deaths were mixed with benzodiazepines.) Demographics or opioid prescription Current highlights of methadone regulation: - Indicated for opioid addiction of at least one year duration. - Clinics must be accredited. - First dose of methadone no higher than 30mg, first day no more than 40mg. - Eight point criteria for gradual increase in take-homes spelled out, include time in treatment, negative tox screens, adherence to treatment, no criminal activity, etc. - Must have diversion control plan. - Monthly random testing, including methadone and methadone metabolite. - Mandated counseling. Federal vs state regulation in California CA still works under the regulation package from 1998, with updates and revisions in various notices over the years. Elements of title 9 are also in the CA Health and Safety Code, and regulatory changes are often dependent on code changes, and cumbersome to update. Several big changes in CA regulation since 1998: allowing admission to MMT after only one detox failure, and one year of opioid addiction (this was a response to the very high risk of HIV), and provisions for monthly take-homes. Only 2 to 5% of patients in California OTPs qualify for monthly visits.

4 medication mis-use is somewhat different compared to heroin. Buprenorphine was strategically located in primary care to address this problem. Methadone clinics also see an increase in patients with primary pill use versus heroin. Models of buprenorphine treatment Office-based, under DATA 2000 Use of buprenorphine to treat opioid addiction as part of office-based practice in primary care or psychiatry. Buprenorphine is prescribed just as any other medication, and picked up by the patient at any retail pharmacy. Treating in this medical model is argued to reduce stigma. OTP-based, under 42 CFR part 8 Buprenorphine is listed as an opioid agonist treatment medication in the federal regulations for methadone clinics. Because of its better safety profile, take-home rules are less stringent than methadone. In 2015 DHCS in California has begun to write regulations that allow buprenorphine to be DMC-covered in OTPs. Induction support Primary care clinicians in the safety net clinics may find it difficult to monitor patients during the first week of treatment, while the dose is adjusted. Timing of the first dose of buprenorphine requires clinician examination for withdrawal, in order not to precipitate unpleasant symptoms. One model for induction is to offer a centralized induction and stabilization process, with subsequent referral to primary care for ongoing medication. In theory this could be done within OTPs, but typical OTP practice is to keep patients enrolled, rather than coordinate with primary care. DATA 2000 and buprenorphine treatment The Drug Addiction Treatment Act of 2000 was signed by President Clinton and allows a waiver to the Harrison Act of The 1914 law made it illegal to prescribe narcotics to an addicted person. These days the word narcotic is only used by DEA, but it remains in some of our statute language, translate opioid and you are usually up to date. Physicians who prescribe buprenorphine must have a special DEA X number, which is obtained after 8 hours of training, and notification to HHS. Physicians with X numbers are inspected by the DEA at their place of practice, when they must show how they keep track of prescriptions and census of active patients in buprenorphine treatment. In the first year of physician waiver, census is limited to 30 patients at a time, and after a year, with additional notification to HHs, census can be expanded to 100 patients at a time. Fully primary care Most buprenorphine treatment in the world is carried out completely within primary care, with nursing support as needed. Team care works well for buprenorphine treatment. Several research studies show that nursing or physician visits work as well or better than counseling for psychosocial support of this medication treatment.

5 Buprenorphine in institutional settings Buprenorphine starts can be carried out in hospitalized patients and incarcerated patients, and continued in primary care upon discharge or release. (Institutional abstinence reduces tolerance, and may lead to overdose upon discharge. Buprenorphine starts in jail prevent overdose upon release.) Both methadone and buprenorphine can be used during pregnancy and breastfeeding, and are associated with better birth outcomes compared to heroin. Step use of buprenorphine and methadone Because methadone is so highly regulated, one model proposed is step treatment. Buprenorphine is tried first, and methadone reserved for patients who don t do well on buprenorphine. This was formally studied in Scandinavia, using patients on a wait list for methadone. 46% of patients stabilized with buprenorphine. Medication to medication comparisons Although ideally both methadone and buprenorphine would be equitably available in any venue, most medication choice is made according to insurance coverage and venue. Direct comparisons of medication show similar effectiveness in reducing opioid use and craving. Retention in treatment is somewhat lower with buprenorphine. Sedation and severity of neonatal abstinence syndrome is somewhat lower with buprenorphine. Opioid side effects such as constipation and sexual dysfunction are somewhat lower with buprenorphine. Clinically significant QT interval prolongation (rare cardiac arrhythmia risk) is seen with methadone and not buprenorphine. Overdose risk is lower with buprenorphine. Buprenorphine is more effective in blocking the effect of other opioids. System considerations The weight of regulation is much higher with methadone than buprenorphine, but there are still restrictions for office-based use of buprenorphine. Physicians who prescribe as part of primary care may need support in training, keeping track of census and keeping prescription logs. Buprenorphine is significantly more expensive than methadone. Observed dosing is part of the diversion control in the OTP, and is simpler with methadone liquid than with a sublingual medication such as buprenorphine that may take a few minutes to dissolve. Outcomes used in opioid MAT Methadone outcomes were mostly studied as compared to injection of heroin, and showed reduced mortality, increase in productive activities, reduced criminal activity, fewer positive opioid tests, excellent retention in treatment, reduced HIV seroconversion, and better birth outcomes. Of course, since there is no randomization to heroin these outcomes, although robust, do not include placebo or heroin arms for ethical reasons. Buprenorphine clinical trials showed equivalence to methadone in retention, reduced opioid positives, and reduced cravings. Subsequent studies show somewhat lower retention with buprenorphine.

6 Studies comparing pill users versus heroin users suggest higher female demographic, higher SES, more physical and psychiatric diagnoses in the pill only users caveat these studies were done while rates of prescription opioid use were increasing throughout the country. Effectiveness of each medication is similar whether used for prescription opioid or heroin use disorder. Adequate dosing is a factor in outcome studies. There is a dose-effect relationship for both medications, giving an average range. Clinics in the US have an average dose of mg of methadone per day. This could be used as a quality marker with clinics that have average below 50mg suggesting sub-therapeutic treatment, and clinics with average above 150 suggesting possible overdose risk. All experts agree that dose should be individualized, with not dose cap for methadone. Blood levels are not such a factor with buprenorphine, because it has an active metabolite. Average doses of buprenorphine are in the US, with a top (or ceiling ) effective dose of 32 mg. Effect of psychosocial treatment in MAT It is clear that a huge part of the treatment effect in opioid agonist pharmacotherapy is due to the brain stabilization provided by the medication itself. Studies comparing detoxification plus enhanced psychosocial treatment versus maintenance clearly favor maintenance medication. Standard of care is to offer- and in OTPs requirepsychosocial support. Recently several studies of minimal treatment or interim treatment that compare medication alone to medication plus standard drug counseling show good results, and bring into question whether patients should EVER be discharged due to nonadherence to counseling requirements, especially those who have shown reduction in heroin use. What about naltrexone for opioid use disorders? Adequate doses: Dose-effect studies suggest that opioid positive urines approach zero in persons who inject heroin when methadone dose is above 80 mg. For methadone, blood level is very dependent on genetics of metabolism, and there is no therapeutic range, with an average dose between mg in the US. Standard practice is to justify doses of buprenorphine of 24 mg. and above. There is anecdotal evidence that diversion and stockpiling is common in buprenorphine doses higher than 16 mg. (As a reference, one clinic in Australia has average dose of 8 mg, and doses of buprenorphine used in other countries for pain are 0.6 mg per day) Naltrexone tablets: Available in primary care with a TAR, also as a DMC outpatient modality. Indicated for relapse prevention after a period of abstinence of at least seven days. This treatment has not been very successful in safety net populations, but has some success among professionals. Law enforcement likes this option, since it blocks all opioid effects. One problem is that it eliminates tolerance, and increases the risk of

7 overdose deaths in case of relapse. But the overall main problem is lack of retention. Naltrexone depot injection: This monthly injection is expensive, and is indicated in patients who wish opioid blockade but who are unable to adhere to daily tablet dosing. The injection releases naltrexone from microspheres that last four weeks, and must be placed in muscle tissue in the hip. So far it has been more successful in reducing alcohol use than in opioid use disorder. Head to head comparison between injected naltrexone and other MAT is lacking. Most clinicians agree that it s a welcome new option for patients who are certain that they don t want other MAT, but clinicians are hesitant to recommend it over buprenorphine or methadone until we have further head to head comparison research. One question is whether it controls craving (tablets do not), and whether overdose risk is increased, as occurs with the tablets. Bottom line: use in alcohol, or in those patients who refuse methadone or buprenorphine and who can t comply with the oral naltrexone. Stay tuned for more information regarding naltrexone injection use in relapse prevention of opioid use disorder.

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