Overview
Medication for opioid use disorder (MOUD) is the standard of care for the treatment of opioid use disorder (OUD) due to its demonstrated effectiveness for treating this disorder and saving lives. MOUD is recommended for all individuals with OUD regardless of the severity of OUD. There are three medications approved by the Food and Drug Administration (FDA) for the treatment of OUD: methadone, buprenorphine and the extended-release (ER) naltrexone injection.
Evidence from studies demonstrate important benefits from MOUD including:
- Reduced opioid use
- Improved treatment retention
- Reduced transmission of HIV and hepatitis C infection
- Reduced criminal activity
- Reduced occurrence of skin infections
Only buprenorphine and methadone, but not ER naltrexone, have been proven to reduce opioid-related (overdose) deaths, as well as deaths due to all-causes.
MOUD continues to be underutilized despite its proven efficacy for the treatment of OUD. Results from a 2021 national survey examining substance use disorder trends revealed that only 22% of people diagnosed with an OUD are prescribed any MOUD. From a second newly published study, only 20% of individuals who initiated buprenorphine for the treatment of OUD remain on this medication after 6 months.
Methadone
As a treatment for OUD, methadone has been available through opioid treatment programs or OTPs (formerly called methadone maintenance treatment programs) since 1969. It is the treatment that has been the most available worldwide, the most studied, and has the most evidence for its effectiveness. Methadone is a full opioid agonist medication which acts at the opioid receptors in the brain. Per federal regulations for OTPs, methadone must be dispensed as an oral medication in a safety deterrent formulation, typically a suspension. To avoid potentially serious side effects, medical providers start this medication at lower doses followed by a build-up to a “blocking dose” (a dose at which an individual who takes additional opioids will not feel their effects). This blocking dose is not the same for all people and is tailored to the individual’s tolerance and needs. Taking methadone once daily in sufficient doses reduces opioid withdrawal symptoms and controls opioid cravings, decreases the risk for opioid-related (overdose) death and death due to all other causes, and leads to positive effects with respect to the health and wellbeing of persons taking it. Continuous use of methadone, as a daily long-term therapy, has been shown to be superior to a methadone taper for achieving these goals. The length of treatment is not pre-determined, but long-term treatment with methadone is strongly encouraged to reduce the risk of return to opioid use and opioid-related (overdose) deaths in addition to premature death from all causes.
Under federal regulations, the prescribing and dispensing of methadone for the treatment of opioid use disorder can be done only in OTPs under the supervision of the program’s staff. Medication dispensing only occurs onsite at the program or its extensions during daily to monthly visits depending on the person’s individual needs and resources. Increased flexibility of methadone take-home doses has been in effect since the COVID-19 federal public health emergency was initiated in March 2020 and is anticipated to remain permanently in place.
Because access to methadone treatment is limited to individuals enrolled in a registered OTP, and because of the paucity of OTPs in less populated regions of the state, the New York State Office of Addiction Services and Supports (NYS OASAS) has invested in alternative strategies to expand access to methadone for individuals in different treatment settings, in remote areas and those with travel restrictions. Some of these strategies have included integrated OTP and outpatient programs, OTP satellite clinics, mobile medication units (MMUs) and methadone delivery service (MDS).
In a new initiative, OASAS is working with 44 programs around the state to integrate methadone into outpatient treatment programs and to expand the scope of services available within the OTPs. With this integrated OTP and outpatient treatment model, individuals enrolled in non-OTP outpatient substance use disorder treatment settings will benefit from the full menu of treatment found in OTPs, including methadone, while those individuals enrolled in an OTP may access the wide array of counseling and group services found in outpatient treatment programs.
In a hub and spoke model, satellite or offsite medication units of a hub or central OTP clinic have provided methadone to individuals unable to travel to the larger centralized OTP clinic because of its geographic limitations.
On July 20, 2023, the first of several OASAS funded and regulated mobile medication units was launched as a mobile extension of a registered brick-and-mortar OTP. The intention of these MMUs is to extend all clinical services of the brick-and-mortar OTPs to individuals who reside in areas inaccessible to an OTP. In addition to providing continuation doses of methadone and buprenorphine through the MMUs, these units will have the capability of completing admissions to the OTPs including the initiation of and stabilization with methadone and buprenorphine. Individuals will have the option to receive medication on a regular basis either on the MMU or at the associated brick-and-mortar OTP. The development of the MMUs is made possible through the changes allowed by the DEA’s FINAL RULE which permitted changes to existing regulations for the OTPs.
Other initiatives have included New York City’s COVID-19 MDS, now concluded, that delivered methadone door to door to enrolled OTP patients who were in isolation or quarantine because of COVID-19 or at elevated risk for COVID-19 acquisition.
In NYS, the federal and state agencies involved with the regulation of methadone include the Drug Enforcement Administration (DEA), Substance Abuse Mental Health Services Administration (SAMHSA), NYS Department of Health, NYS Bureau of Narcotic Enforcement and OASAS.
Buprenorphine
In 2000, the US Congress passed the Drug Addiction Treatment Act (DATA) 2000 permitting office-based prescribing of buprenorphine for OUD treatment. Prior to the year 2000, the only option for approved OUD treatment was OTP-based methadone.
- Buprenorphine is a partial opioid agonist medication which partially blocks the opioid receptors in the brain. As a partial agonist, buprenorphine has two main functions in the brain. The medication reduces opioid withdrawal symptoms and opioid cravings as well as protecting against opioid overdose if someone taking the medication returns to opioid use.
- Because buprenorphine is a partial agonist, there is a ceiling effect so that once a sufficient dose of medication is taken, additional doses of buprenorphine generally do not produce additional positive or negative effects. This ceiling effect means that buprenorphine is safer than other opioids regarding its risk of respiratory depression (slowed breathing) that may occur with other opioid medications.
Studies also have shown that taking buprenorphine continuously (as long-term treatment) is superior to a short-term buprenorphine taper for preventing return to opioid use and opioid-related (overdose) deaths in addition to premature death from all-causes.
Buprenorphine is available in several FDA-approved formulations for opioid use disorder: sublingual or buccal tablets or films (Suboxone, Zubsolv, Subutex) dissolved under the tongue or inside of the cheek (per manufacturer package insert) and an extended-release (ER) injection (Sublocade) injected subcutaneously (shallowly under the skin). A new FDA-approved buprenorphine ER injection that may be administered as a once-weekly or once-monthly ER subcutaneous injection (Brixadi) is due for release in September 2023.
Unlike the federal requirements for methadone and buprenorphine dispensing within the OTP, buprenorphine prescribed outside the OTP may be obtained by prescription through a community-based pharmacy. As a controlled substance, this medication may be dispensed only up to a 30-day supply; however, refills may be given depending on the individual’s needs.
Some sublingual formulations combine buprenorphine with small amounts of naloxone (an opioid receptor antagonist or blocker), intended to deter medication diversion and use of the medication by injection.
Because of the broad distribution of illicitly manufactured fentanyl and its analogues in the unregulated drug supply, medical providers are exploring alternative approaches to buprenorphine initiation to address the different way that fentanyl behaves in the body. The main goal of these newer strategies is a successful initiation of buprenorphine that avoids a severe and sudden opioid withdrawal. Opioid withdrawal may occur when initiating buprenorphine in individuals who may be using fentanyl if initiated too soon after last use.
Currently, there is no consensus on best practice for these protocols. For more information, see the following two publications:
Extended-release (ER) naltrexone injection
Naltrexone is an opioid antagonist medication which binds to the opioid receptors in the brain, blocking the effects of opioids if the individual returns to opioid use. Naltrexone comes two formulations: an oral tablet (ReVia) and ER injection (Vivitrol) injected into the muscle. Both formulations are indicated for alcohol use disorder, but only the ER injection formulation is indicated to treat OUD.
Naltrexone is a non-opioid, non-controlled medication; therefore, it does not have the same prescribing limitations as methadone or buprenorphine. The ER injection formulation can be administered in a medical office with a medical order while the oral formulation is refillable and dispensed from a community-based pharmacy with a prescription.
Information about naltrexone for the treatment of alcohol use disorder can be found on the OASAS webpage: medications for the treatment of alcohol use disorder .
ER naltrexone injection can be started when opioids (such as heroin, fentanyl, methadone, buprenorphine, oxycodone, etc.) are no longer in the body. After the last use of an opioid like fentanyl, the body starts metabolizing and eliminating the opioid; however, this process takes many days to eliminate the opioid and all its break-down products completely.
Before administering ER naltrexone, a medical provider must confirm that all opioids have been eliminated from the body with a urine toxicology test. The provider can consider an intranasal naloxone challenge (if the patient is willing) and should do an oral naltrexone trial to assess tolerance to the medication in anyone who is naltrexone naïve. Giving any form of naltrexone to a person that still has an opioid in their body will cause precipitated opioid withdrawal.
Naltrexone in any formulation is contraindicated in people with severe or acute hepatitis, with decompensated cirrhosis of the liver, and in people with an allergy to naltrexone. Prior to initiating treatment with ER naltrexone, people with advanced liver disease and pregnant persons should consult with an experienced medical provider to discuss treatment options and weigh the risks and benefits of this treatment.
Training
- Through the Section 1262 of the Consolidated Appropriations Act 2023, the federal government has eliminated the DEA X waiver requirement to prescribe buprenorphine. With this change, there is a new DEA educational requirement effective June 2023 that providers complete a one-time 8-hour training on substance use disorder or opioid use disorder at the time of DEA registration or renewal.
- Beginning on June 27, 2023, all DEA-registered and new medical practitioners are required to attest to completion of the training when renewing or completing an initial registration. Details on this new requirement may be reviewed on the DEA and SAMHSA webpages.
- Some medical providers are exempt if they already have satisfied training requirements. See details in the December 2022 Dear DEA Registered-Practitioners letter.
Clinicians may choose from a variety of educational options, including but not limited to the following:
- The SAMHSA-funded Providers’ Clinical Support System (PCSS)
More details on curricular requirements may be found on the SAMHSA page: Recommendations for Curricular Elements in Substance Use Disorders Training
Mentoring options for new buprenorphine prescribers can be found through several programs:
- pcssnow.org/mentoring/
- NYC DOH buprenorphine mentorship: [email protected]
For more information about buprenorphine from the New York State Department of Health (NYS DOH), including helpful materials for providers developed for their Buprenorphine Public Health Detailing Initiative, visit the NYS DOH Buprenorphine page.
Resources
The OASAS Provider Directory helps locate substance use disorder treatment providers including OTPs. The searchable directory allows filtering by county, region, city, zip code and proximity to help narrow searches.
To find an opioid treatment program in the OASAS Provider and Program Directory:
- Select Treatment Programs under Program Type
- Select Opioid Treatment Program from the Search by drop down menu.
- Filter by location and/or proximity
In October 2021, NYS implemented a single statewide formulary for buprenorphine and naltrexone covering all preferred products without prior authorization.
In December 2022, OASAS and the NYS DOH jointly launched a pilot program called Bupe-AP, Buprenorphine Assistance Program, modeled after ADAP (AIDS Drug Assistance Program). Bupe-AP is a low threshold program that will cover the cost of buprenorphine for eligible uninsured and under-insured individuals with no out of pocket costs for their medication.
For more information on the December 29, 2022, elimination of the DEA X waiver, see the OASAS guidance on Elimination of the DEA X Waiver to Prescribe Buprenorphine. Additional information on the elimination of the DEA X Waiver can be found from SAMHSA and the DEA.