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Comment & Response
February 2018

Tramadol Extended Release and Opioid Withdrawal Management—Legal Implications

Author Affiliations
  • 1Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill
JAMA Psychiatry. 2018;75(2):214-215. doi:10.1001/jamapsychiatry.2017.4015

To the Editor The study investigating the efficacy of tramadol extended release for opioid withdrawal by Dunn et al1 offers a promising approach to the management of acute opioid withdrawal. Substance abuse treatment programs in the United States that provide management of acute opioid withdrawal in inpatient and residential settings currently use methadone (if registered as a narcotic treatment program), buprenorphine, or nonopioid medication (such as clonidine), and the results of the study by Dunn et al1 suggest that tramadol extended release may be an additional tool in the addiction psychiatrist’s armamentarium for treating patients in acute opioid withdrawal. However, based on my understanding of the US federal drug laws, the use of tramadol extended release may only be permissible if the treatment program is registered with the US Drug Enforcement Administration as a narcotic treatment program. For inpatient and residential substance abuse treatment programs not registered with the US Drug Enforcement Administration as a narcotic treatment program, federal law2 stipulates that only Schedule III, IV, or V narcotic medications approved by the US Food and Drug Administration specifically for use in opioid maintenance or detoxification treatment can be dispensed or prescribed. Because tramadol extended release is a Schedule IV narcotic medication and is not currently approved by the US Food and Drug Administration for treatment of opioid dependence, its use in opioid withdrawal management appears to be forbidden by this law unless the treatment program is registered by the US Drug Enforcement Administration as a narcotic treatment program. At the present time, there is only 1 opioid medication available that meets the criteria for use in a program that is not registered as a narcotic treatment program: buprenorphine.2 Many addiction treatment centers in the United States providing opioid withdrawal management (ie, “detoxification”) services are not registered with the US Drug Enforcement Administration as a narcotic treatment program, and it is important that health care professionals are aware of the federal regulations governing the use of opioid medications in treating patients with substance use disorders.

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