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CDER Conversation: Treatment for Opioid Use Disorder

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Photos of Dr. Mitra Ahadpour for CDER Conversation

Talking with Mitra Ahadpour, M.D., DABAM, who is the deputy director of CDER’s Office of Translational Sciences.

Medication assisted treatment (MAT) is a term used to describe the use of medication, along with other supports, to treat opioid, tobacco or alcohol use disorder. Although the term and method are not new, MAT has recently gained renewed attention as a key to combating opioid use disorder (OUD), which is a chronic health condition that can be life-threatening but also treatable.

Mitra Ahadpour, who is the deputy director of CDER’s Office of Translational Sciences and an addiction medicine specialist, discusses how MAT works, and its importance in the fight against the opioid crisis that is currently affecting communities across the nation.

What is MAT and how does it work?

MAT is evidence-based treatment that includes FDA-approved medication combined with counseling and psychosocial support. Medications approved to treat OUD include methadone, buprenorphine and naltrexone. These medications decrease cravings associated with addiction. Buprenorphine and methadone also help to relieve withdrawal symptoms. None of them cause euphoria or a “high” when used as directed. In addition, the drug naloxone can serve as an antidote to opioid overdose by blocking the opioid receptor sites.

It is important to remember that MAT is broader than just the use of medication. To be fully effective, MAT incorporates a multipronged approach that can include counseling, vocational training, psychosocial therapy, family support, and building connections to community resources. There is no one pathway to recovery. The duration of treatment that is necessary depends on the unique needs of the individual. A successful individualized treatment plan is built on a therapeutic alliance with treatment providers, and social and emotional support. Providing patients with non-judgmental and empathetic support in the face of setbacks is essential for long-term recovery.

Because OUD is a chronic illness, we should consider treating it much like we would any other chronic condition. We do not think of the medications used to treat diabetes or hypertension as “medication assisted treatment.” We simply call it “treatment.” OUD should be viewed similarly.

Why is MAT important in the fight to curb the nation’s opioid crisis?

The opioid epidemic is widespread and impacts not only individuals, but also families and whole communities. Many of us know someone who has been affected. In the past year, approximately 1 in 8 children aged 17 or younger lived in households with at least one parent who had a substance use disorder.i Tragically, only about 20 percent of individuals with OUD receive any kind of treatment.ii Yet clear evidence suggests that with MAT, social functioning improves, and the risks of overdose mortality and of contracting an infectious disease such as HIV also decrease.iii

How are MAT drugs administered?

MAT drugs can be administered through different routes depending on the specific drug. For instance, methadone is orally administered through accredited Opioid Treatment Programs (OTPs) that must be certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) and registered with the Drug Enforcement Administration. A patient taking methadone must generally visit the clinic every day to take the medicine under appropriate supervision. During the first 90 days of treatment, a patient may be able to take one dose per week at home.

Buprenorphine can be prescribed by a qualified physician, physician assistant, or nurse practitioner at OTPs or office-based practices, per federal regulations. Buprenorphine is available in sublingual (under the tongue), buccal (in the cheek), extended-release injectable, and implant formulations. Naltrexone can be prescribed by physicians, physician assistants and nurse practitioners who are licensed to prescribe medications. Naltrexone is available in oral and extended-release injectable formulations. The extended release injectable formulation appears to improve adherence rates compared to the oral tablets.

Despite these multiple options, many clinicians are not assessing and treating patients with OUD.iv They may not be aware of the benefits and the evidence-based effectiveness of the treatment. Moreover, many health professionals are not sufficiently trained to assess for substance use disorder and provide MAT. Therefore, lack of knowledge or familiarity with MAT may contribute to the growing opioid crisis. We need new approaches to educate and encourage more effective collaboration among prescribers and other health care providers—an all-hands-on-deck approach—to reach more people with OUD.

What are the potential drug-drug interactions associated with MAT drugs that patients and doctors should be aware of?

As with any medication, drug-drug interactions are possible. With MAT drugs, it is important to avoid taking other drugs that are classified as central nervous system (CNS) depressants, which can suppress breathing. Specifically, benzodiazepines should not be co-prescribed with opioids, including MAT drugs, because the combination can increase the risk of overdose and potentially lead to death. CNS depressants, including alcohol and sedative-hypnotic medications, should be avoided while taking opioids.

However, excluding patients from MAT or discharging patients from treatment because of use of benzodiazepines or CNS depressants is not likely to stop them from using these drugs altogether. Instead, they may continue to take them outside of treatment, which could result in more severe outcomes. Health care professionals should take precautions and develop a careful treatment plan when MAT drugs are being used in combination with benzodiazepines or other CNS depressants to manage and reduce risks to patients.v

Is MAT safe for pregnant women and their babies? What must they consider when undergoing MAT?

Yes, MAT is recommended for pregnant women with substance use disorder. Pregnant women on MAT are more likely to adhere to prenatal care and substance use treatment programs. Adherence to prenatal care can decrease the risk of infant death, preterm birth, low birthweight, and other complications for the infant and mother. Studies in pregnant women on MAT who are also receiving counseling and support services have shown that they also experience fewer obstetrical complications. Women in treatment are less likely to relapse, acquire HIV or another infectious disease, or overdose. For the most part, the cognitive development of infants exposed in utero to methadone is similar to that of control groups matched for age, race, and socioeconomic status.vi

To help give caregivers information about MAT, labeling for methadone and buprenorphine include information for use during pregnancy, and the American College of Obstetricians and Gynecologists recommends either of them for OUD treatment. They call for whole-person care that includes counseling, psychosocial interventions, and treating co-occurring disorders and poly-substance use.

Opioid- exposed newborns, including those whose mothers are undergoing MAT, may experience neonatal opioid withdrawal syndrome (NOWS), also known as neonatal abstinence syndrome. Babies with NOWS may show more agitation or distress than a typical newborn. However, not all babies experience these withdrawal symptoms, nor do they necessarily need medication to ease symptoms. Studies have found that many newborns with NOWS can remain in the hospital room with the mother.vii A calm, quiet environment and frequent skin-to-skin contact with the mother can facilitate closer bonding and help ease a newborn’s withdrawal symptoms.

How can patients overcome barriers (e.g., cost, coverage limits, lack of providers) to accessing MAT?

SAMHSA’s treatment locator service can be helpful in finding a nearby treatment program. The service also can help locate a health care provider or treatment program that offers buprenorphine specifically. Through collaboration, solutions can be created to eliminate the remaining barriers. The FDA is committed to addressing the opioid crisis and to improving access to treatment.

For More Information:

FDA Information about Medication Assisted Treatment

SAMHSA: Find Help and Treatment

U.S. Department of Health and Human Services: How to Find Opioid Treatment Programs

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i Lipari, R.N. and Van Horn, S.L. Children living with parents who have a substance use disorder. The CBHSQ Report: August 24, 2017. Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Rockville, MD.

ii https://www.samhsa.gov/data/report/results-2016-national-survey-drug-use-and-health-detailed-tables.

iii Volkow, N. Medication assisted therapies – tackling the opioid-overdose epidemic. NEJM. 2014. 370(22), 2063-2066.

iv Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and .Health. Chap 6: Health Care Systems and Substance Use Disorders. https://www.ncbi.nlm.nih.gov/books/NBK424848/.

v FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks.

viAmer Soc. Of Obstetricians and Gynecologists and Amer. Soc. Of Addiction Medicine. ACOG Committee Opinion on Opioid Use and Opioid Use Disorder in Pregnancy. 2017 Aug. 711.

viiJAMA Pediatr. 2018 Apr 1;172(4):345-351. doi: 10.1001/jamapediatrics.2017.5195. Association of Rooming-in With Outcomes for Neonatal Abstinence Syndrome: A Systematic Review and Meta-analysis.