Naltrexone is a medication primarily used in the treatment of opioid use disorder and alcohol dependence. It serves as a component of medication-assisted treatment (MAT), supporting individuals in their recovery. This article clarifies whether naltrexone is considered a controlled substance.
What Defines a Controlled Substance
A controlled substance is a drug or chemical whose manufacture, possession, or use is regulated by a government due to its potential for abuse or dependence. These substances are classified into different schedules based on their accepted medical use and likelihood for misuse. In the United States, this classification is governed by federal laws, primarily the Controlled Substances Act (CSA) of 1970.
The CSA categorizes controlled substances into five schedules, ranging from Schedule I to Schedule V. Schedule I drugs have a high potential for abuse and no accepted medical use, while Schedule V drugs have a low potential for abuse and limited quantities of certain narcotics. The placement of a substance within these schedules depends on its potential for abuse, its accepted medical use, and the degree of dependence it may cause. This system helps regulate substances that can lead to severe psychological or physical dependence, such as opioids, stimulants, and depressants.
Naltrexone’s Legal Standing
Naltrexone is not classified as a controlled substance under federal law, including the Controlled Substances Act, nor is it generally controlled at the state level. This distinction is due to its pharmacological properties and how it interacts with the body. Unlike opioids, naltrexone does not produce euphoric effects or physical dependence, which are characteristics of controlled substances with abuse potential.
Naltrexone works as an opioid antagonist by blocking opioid receptors in the brain. This prevents the pleasurable effects of opioids and reduces cravings for both opioids and alcohol. Because naltrexone does not induce a “high” or lead to addiction, it does not carry the same risks of diversion or misuse as controlled substances. Its classification was changed, with its main metabolite, 6β-naltrexol, removed from controlled schedules in January 2020.
Access and Prescribing Naltrexone
The non-controlled status of naltrexone has implications for its accessibility and prescribing. While not a controlled substance, naltrexone remains a prescription medication, requiring authorization from a licensed healthcare provider. Prescribers of naltrexone do not need the DEA registration required for dispensing controlled substances.
This lack of stricter regulatory requirements eases access for patients seeking treatment for opioid or alcohol use disorder. Any qualified medical doctor can prescribe naltrexone, unlike many controlled medications. Naltrexone is available in both oral tablet form and as an extended-release injectable. Patients must be opioid-free for 7 to 10 days before starting naltrexone to avoid precipitated withdrawal.