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Is naltrexone a controlled substance?

Is naltrexone a controlled substance?

Naltrexone is not a controlled substance and is approved by the FDA for managing opioid use disorder and alcohol dependence.

Over 16 million people worldwide are struggling with opioid use disorders. The U.S Food and Drug Administration has approved naltrexone for treating opioid use disorder and alcohol dependence as a part of Medication Assisted therapy (MAT). Naltrexone is a long-acting opioid antagonist (i.e., inhibits the action of opioids) and is neither opioid nor addictive.

The healthcare professionals at Confidant Health are ready to answer your questions and provide MAT for managing opioid use disorder and alcohol addiction.

Is naltrexone a controlled substance?

By the Controlled Substances Act, Controlled substances refers to the substances that have a high potential for misuse. On the other hand, naltrexone doesn’t have the potential for abuse or addiction; hence, it is not classified as a controlled substance. 

Nonetheless, naltrexone has some side effects and can interact with other medical conditions or drugs. That is why you will require a licensed physician’s prescription to get naltrexone. You can also get naltrexone while taking online Medication Assisted Therapy (MAT) from an online platform such as Confidant Health.

What is naltrexone?

Naltrexone is an opioid antagonist that blocks or inhibits the actions of opioids in the body. By doing so, naltrexone decreases the cravings for opioids. Moreover, it also binds to specific alcohol-related receptors (known as endorphins), reducing the effects and feelings of alcohol. 

Naltrexone can be taken either orally or in intramuscular form. The oral dose is usually given once daily, while intramuscular injections are administered monthly. Although it is not a controlled substance, you need a physician’s prescription before taking naltrexone.

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How does naltrexone work?

Opioids produce euphoric feelings by activating the special receptors in our brain, known as opioid receptors. Naltrexone directly interacts with these receptors and blocks the actions of opioid substances. By inhibiting the actions of opioid substances, one may feel no euphoria or other positive feelings despite taking opioids.

Similarly, alcohol stimulates some receptors and pathways associated with pleasure (also known as reward centers of the brain). By activation, the brain associates pleasure with alcohol, increasing the desire to drink alcohol. Naltrexone blocks such receptors, reducing the desire for drinking. 

However, naltrexone itself is not an opioid or narcotic substance, so it has no potential for misuse or addiction.

Composition of naltrexone

Oral naltrexone tablets contain naltrexone hydrochloride, generally in 50 mg composition (taken once a day). The injectable naltrexone contains a poly matrix of the drug (380 mg) with small amounts of another chemical, ethyl acetate. Upon intramuscular administration, it is released slowly over an extended time. That’s why intramuscular naltrexone is usually administered once a month.

Naltrexone for opioid use disorder

Opioid use disorder, also known as opioid addiction, refers to the increased and persistent use of opioids despite their side effects, and it usually presents with the following signs and symptoms: 

  • Opioid cravings, i.e., strong urge to use opioids.
  • Increased use over time
  • Symptoms of opioid withdrawal when you try to decrease the dose or stop taking opioids. (These may include agitation, anxiety, runny nose, diarrhea, muscle pain, sweating, and insomnia).

As an opioid antagonist, naltrexone can block the effects of opioids on different parts of the body. Thus, you will have a significant decrease in opioid cravings. Due to the effectiveness of naltrexone in treating opioid use disorder, it is considered an important component of MAT.

However, you can start naltrexone only if you haven’t taken opioids for a certain period. This period is almost one week for short-acting opioids and two weeks for long-acting opioids. There’s an increased risk for withdrawal symptoms if you are not opioid-free while taking naltrexone.

Naltrexone for alcohol use disorder

Alcohol use disorder, or alcoholism, refers to the impaired ability to control alcohol intake despite its adverse effects. Alcohol use disorder usually presents with variable signs and symptoms of increased urge, preoccupation with alcohol intake, and withdrawal symptoms. 

In alcohol use disorder, a strong association is formed between pleasure and alcohol intake. That is why you may experience withdrawal symptoms and displeasure when you don’t take alcohol. Naltrexone can help break this association by blocking the euphoric feelings and effects of alcohol intoxication. That’s why it is used as an adjunct therapy for treating alcoholism.

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Side-effects of naltrexone

Although naltrexone is not a controlled substance, it can lead to many side effects, such as the following:

  • Gastrointestinal symptoms including nausea, vomiting, decreased appetite, and abdominal pain.
  • Headache, dizziness, and insomnia.
  • Pain in muscles and joints.
  • Allergic reactions including skin rashes, face or eye swelling, or wheezing.
  • Hepatotoxicity may present with signs of hepatitis or severe liver damage.
  • In some cases, pneumonia may also occur as a serious complication of naltrexone.
  • Opioid overdose risk.

That’s why you must inform your physician about your current liver problems, medications, and any allergy to naltrexone. 

Can you take naltrexone in pregnancy?

Due to its adverse effects, FDA has recommended avoiding naltrexone use while you are pregnant or breastfeeding.

Opioid overdose risk

Opioid overdose can lead to respiratory depression, coma, and death. In people taking naltrexone, opioid overdose can occur due to two main reasons:

  • Naltrexone blocks the effects of opioids, so people may try to overcome these blocking effects by taking high amounts of opioids.
  • Naltrexone can increase the sensitivity to opioids, making you experience the effects of opioids even at a lower dose. It happens because the effects of naltrexone fade slowly and take some time to get out of your body completely.

Medication Assisted Treatment at Confidant Health

Confidant Health provides online Medication Assisted Therapy (MAT) for those struggling with opioid use disorder and alcohol dependence. The qualified healthcare professionals at Confidant Health can prescribe FDA-approved naltrexone to help you cope with both alcohol use disorder and opioid use disorder. To begin MAT, you can download our app at Google Play Store or Apple Store.

This article has been medically reviewed by
Erin Hillers
Erin Hillers
Erin Hillers
Nurse Practitioner

Erin is a Nurse Practitioner with 8 years of experience in midwifery and women's health. She has spent the past 5 years specializing in the treatment of opioid and alcohol use disorders.

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