Is Naltrexone a Controlled Substance?

July 6, 2022

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No, Naltrexone is not a controlled substance.

Naltrexone (also called by its brand name “Vivitrol”) is an opioid antagonist medication used to treat both opioid use disorder (OUD) and alcohol use disorder (AUD).

Many addiction treatment medications, including methadone and buprenorphine, are controlled substances. Methadone is a full opioid agonist, meaning it can work on brain receptors just like heroin or prescription painkillers. Buprenorphine is a partial agonist, meaning it can work on those receptors but not as strongly. Both of these medications are opioids, and they are both considered controlled substances.

Naltrexone is different. It is not a controlled substance. This medication is actually an opioid antagonist, which means it blocks substances like heroin and painkillers from causing a euphoric or “high” effect in the body.[1] This is the way in which it works as a treatment for opioid use disorder: when taken, it prevents the individual from getting high off of an opioid medication.

You can't get high on naltrexone, so it's not considered a dangerous or controlled substance by the U.S. Food and Drug Administration. 

What is the difference between an over the counter medication, a prescription medication, and a “controlled substance”?

Naltrexone is a prescription medication, but not a controlled substance.

A medication that is “over the counter” is a medication that can be purchased at any pharmacy without a prescription. Usually these medications are very safe for general use. For example, Tylenol, ibuprofen, cough syrup, vitamins, etc. can all often be purchased “over the counter”.

A prescription medication is any medication that requires a prescription from a licensed medical professional. These medications are also generally safe, but may require some education or counseling about potential risks and side effects. For this reason, a prescription is necessary to ensure that the patient has met with the doctor and received education about how to properly take the medication and monitor for any worrisome side effects.

A “controlled substance” is a medication that is generally thought to be more dangerous than your average prescription medication, and is required to be prescribed by a physician that has a special license, called a DEA license. The reason for this is that DEA licensed providers have received additional training in how to properly administer substances that are potentially dangerous or addictive. All opioids are considered “controlled substances”, including opioids that are actually used to treat OUD - Methadone and Suboxone. 

How Is Naltrexone Regulated?

While naltrexone isn't a controlled substance, it's not sitting on pharmacy shelves either (“over the counter”). Instead, it's a prescription medication that you must visit a doctor to get.

There is no diversion or abuse potential with naltrexone.[2] But it's still a medication that, like all medications, can cause side effects in some people. Ideally, it should be used in concert with traditional addiction care tools, such as therapy and group meetings, to help patients recovering from a SUD. 

What is the Difference Between Naloxone and Naltrexone?

Naloxone and Naltrexone sound similar. They are both opioid antagonists. The main difference is that Naloxone is a fast acting antagonist that blocks the effects of opioids immediately (within minutes). It is used primarily to reverse an overdose of opioids. For this reason, most states do sell it “over the counter” without a prescription, so that anybody who has a personal history of opioid use or a friend or family member with opioid use can access it and have it in case of an emergency.

Naltrexone, on the other hand, is a slower acting opioid-antagonist, and will not immediately reverse an overdose the way that Naloxone will. Naltrexone, unlike Naloxone, is used primarily as a long term treatment to prevent opioid (or alcohol) misuse, and requires a prescription from a medical doctor. 

How to Find a Naltrexone Provider

Since naltrexone isn't a controlled substance, doctors don't need special training or licenses to prescribe it to their patients. You should be able to visit any qualified medical doctor and get a prescription for the medication.

Many primary care doctors treat patients with OUD or AUD and most do prescribe Naltrexone. However, some primary care doctors aren't comfortable managing addictions in their patients. While they may be qualified to dispense this drug, they may be uncomfortable with directing you to therapy and supervising your recovery. If this is the case, ask your primary care doctor to refer you to another primary care doctor, psychiatrist, or addiction specialist that does feel comfortable prescribing Naltrexone and treating patients with opioid use disorders.

A major manufacturer of naltrexone maintains a list of doctors who prescribe the medication.[3] Search it online to find a doctor near you.

In addition, most addiction treatment facilities, if you are already in a program, offer Medication for Addiction Treatment, including Naltrexone. Many programs have addiction treatment specialists on their staff who can prescribe these vital medications to support your recovery. If your primary care doctor won't give you the drug, it could be a sign that you should enroll in a specialized treatment program that does provide Naltrexone.

Remember, a prescription alone isn't enough to address your substance misuse. Comprehensive care that combines both medications as well as behavioral and social support, is the best strategy for truly achieving sustained recovery.

With the right help, you can build a healthy, balanced life in recovery. Ask your doctor if Naltrexone might be a tool for you in helping you reach your recovery goals.

Elena Hill, MD, MPH

Elena Hill, MD; MPH received her MD and Masters of Public Health degrees at Tufts Medical School and completed her family medicine residency at Boston Medical Center. She is currently an attending physician at Bronxcare Health Systems in the Bronx, NY where she works as a primary care physician as well as part time in pain management and integrated health. Her clinical interests include underserved health care, chronic pain and integrated/alternative health.

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  1. An Introduction to Extended-Release Injectable Naltrexone for the Treatment of People with Opioid Dependence. Substance Abuse and Mental Health Services Administration. 2012. Accessed June 2022.
  2. Naltrexone. Substance Abuse and Mental Health Services Administration. April 2022. Accessed June 2022. 
  3. Find a Provider. Vivitrol. Accessed June 2022.

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