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<h1> Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose </h1>
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<h2>Overview&nbsp;</h2>
<h3>The Research Need&nbsp;</h3>
<p>Currently, only a few medications are approved by the U.S. Food and Drug Administration for the treatment of opioid use disorder and withdrawal. However, these treatments are under-used, and they may not be as effective against synthetic opioids and drug combinations (including stimulants) that are driving record-high numbers of overdoses. More effective and flexible treatment options are also needed to meet the needs of individuals with co-occurring mental health disorders that increase the risk for addiction and overdose.</p>
<h3>About the Program&nbsp;</h3>
<p>This program identifies and develops innovative technologies and therapeutic approaches (small molecules, biologics, and others) to prevent and treat opioid use disorder and stimulant use disorder, as well as to reverse opioid-induced respiratory depression and overdose. This research mainly supports the development of new medications that are more effective and accessible, and that have fewer side effects than current options. Research includes all stages of development, from identification of novel compounds to clinical testing in humans.</p>
<p>The program includes a focus on medication development for use by vulnerable populations, such as pregnant women and newborns experiencing opioid withdrawal. This research also develops new medications, combinations of medications, and non-medication treatment approaches (alone or in combination) for use by people with co-occurring misuse of opioids and/or stimulants and mental health disorders.</p>
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2022
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Notice of Special Interest (NOSI): HEAL Initiative: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose
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Sep 28, 2022
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2022
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Notice of Special Interest (NOSI): HEAL Initiative: Grand Opportunity in Medications Development for Substance-Use Disorders
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Sep 29, 2022
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2025
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Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
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2025
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Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
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Jan 03, 2025
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Research Examples
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<p>Research examples supported by this program include:&nbsp;</p>
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<li>Developing technology to control the release of opioid medications in the body to treat opioid use disorder or prevent relapse</li>
<li>Developing medications and medical devices to manage opioid withdrawal, reduce cravings, and lower the risk of a relapse in people receiving treatment for opioid use disorder</li>
<li>Developing opioid vaccines to reduce the risk of an opioid overdose and to treat opioid use disorder</li>
<li>Optimizing oral, injectable, and implantable, long-acting medications to treat opioid use disorder</li>
<li>Developing medical devices to detect an opioid overdose and automatically administer life-saving medications</li>
<li>Developing medications that can prevent or reverse opioid-induced respiratory depression</li>
<li>Developing medications for the treatment of stimulant use disorder, withdrawal, and overdose as well as co-occurring opioid and stimulant use disorders; or reversing concurrent opioid and stimulant overdose</li>
<li>Developing new (or repurposing existing) medications and devices to treat co-occurring opioid use disorder and mental health disorders</li>
<li>Developing digital therapeutics to deliver treatments that are safe and effective in people with substance use disorders</li>
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