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  6. Focus Area: Substance Use Disorders
  1. Focus Areas of Regulatory Science Report

Focus Area: Substance Use Disorders

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Importance to FDA

Substance use disorders are the persistent use of substances with abuse potential such as opioids, stimulants, cannabis, or nicotine-containing tobacco products, despite substantial harm and adverse consequences. Substance use disorder and fatal overdoses may involve multiple substances, often from different drug classes. In the United States, opioid use-related death is a recognized public health emergency.

In addressing the opioid crisis, the Agency priorities include:

  1. Decreasing Exposure and Preventing New Addiction
  2. Supporting Treatment of Those with Opioid Use Disorder
  3. Fostering Development of Novel Pain Treatment Therapies
  4. Improving Enforcement and Assessing Benefit‒Risk

While there are several FDA-approved medications for treatment of opioid use disorders (containing buprenorphine, methadone, or naltrexone as active ingredients), there are no therapies for certain vulnerable populations such as: (1) young adolescents; and (2) neonates exposed to opioids in utero and who suffer withdrawal upon birth. Additionally, there are currently no FDA-approved medications for treating stimulant use disorders, which is why the Agency is focusing on supporting development of such treatments, as well as treatments for cannabis use disorder, alcohol use disorder, substance withdrawal syndromes, and a variety of other substance use disorders.

FDA is also concerned with the negative health effects associated with tobacco product use. The Agency reviews, among other things, the toxicity and potential abuse liability of new tobacco products before they can be introduced into interstate commerce.


FDA supports or performs research to address substance use disorders and adverse consequences of drug use:

  • Developing a national-level system dynamics model of the opioid crisis to inform assessment of new opioid policy initiatives. The model provides a tool for assessing patterns, contributing factors, and trajectories of problematic prescription and illegal opioid use and substance use disorders.
  • Conducting targeted nonclinical and clinical studies to evaluate respiratory risk associated with the simultaneous use of opioids and other sedative psychotropic drugs and developing mechanistic-based computational models to predict required naloxone dosing for reversal of opioid overdose.
  • Evaluating infants receiving opioid replacement drug therapy for opioid withdrawal syndrome for potential impairment of the growth and development of the brain and/or central nervous system.
  • Creating and participating in partnerships with other Federal agencies and external organizations to build data infrastructure, refine study methodologies, create data linkages, and improve the quality of data that can be used to evaluate substance abuse trends and related adverse outcomes.
  • Supporting extramural research projects to better understand the trajectories of substance use and use disorders, with particular focus on the development of stimulant use disorders and the relationships between prescription and illicit stimulant use.
  • Supporting collaborative research focused on the abuse liability of tobacco products, including examinations of nicotine pharmacokinetics, product use behaviors, and subjective effects to better understand the addiction potential of many different tobacco products.
  • In May 2018, FDA launched an opioid crisis innovation challenge to help combat the opioid crisis and achieve the goal of preventing and treating opioid use disorder. The initiative is intended to spur the development of medical devices, including diagnostic tests and digital health technologies.




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