Naltrexone is not considered to be a controlled substance. According to the FDA, effective January 2020, “With the issuance of this final rule, the Acting Administrator of the Drug Enforcement Administration removes (5α,6β)-17-(cyclopropylmethyl)-4,5-epoxymorphinan-3,6,14-triol (6β-naltrexol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, 6β-naltrexol was a schedule II controlled substance because it can be derived from opium alkaloids.”
Key Takeaways
In January of 2020 both the FDA and DEA reclassified 6β-Naltrexol. The primary substance found in Naltrexone as not a narcotic or controlled substance. 6β-hydroxynaltrexone is a peripherally-selective opioid receptor antagonist related to naltrexone.
Based on the changes made by both the FDA and DEA, Naltrexone and 6β-Naltrexol is no longer considered to be a controlled substance.
Is Naltrexone a Narcotic?
No, Naltrexone is not a narcotic and it is not considered a controlled substance. According to Mayo Clinic, “It works by blocking the effects of narcotics, especially the "high'' feeling that makes you want to use them. It also may block the "high'' feeling that may make you want to use alcohol. It will not produce any narcotic-like effects or cause mental or physical dependence.”
Read more: What to avoid when taking low-dose Naltrexone
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Sources
Patient Counseling Tool - Vivitrol (naltrexone for extended-release injectable suspension). FDA. Accessed April 21, 2024 at https://www.accessdata.fda.gov/drugsatfda_docs/rems/Vivitrol
Naltrexone Monograph. Drugs.com Accessed April 21, 2024 at https://www.drugs.com/monograph/naltrexone.html
Sullivan MA, Bisaga A, Pavlicova M, et al. A Randomized Trial Comparing Extended-Release Injectable Suspension and Oral Naltrexone, Both Combined With Behavioral Therapy, for the Treatment of Opioid Use Disorder. Am J Psychiatry. 2019;176(2):129-137. doi:10.1176/appi.ajp.2018.17070732
Vivitrol (naltrexone for extended-release injectable suspension) intramuscular. Accessed April 21, 2024 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021897s049lbl.pdf
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