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In Search Of A Stimulant Use Disorder Treatment: ‘We’ve Been Doing It Wrong’

 
• By Brenda Sandburg

US FDA official questions whether problem is due to population selection, outcome measures, or study duration. Potential endpoints include change in disease status as measured by DSM-5 criteria, cognitive function and quality of life, experts say.

substance use disorder
Researchers seek to overcome hurdles to development of a treatment for stimulant use disorder • Source: Alamy

Despite decades of research, development of a treatment for stimulant use disorder remains elusive. Experts are now hunkering down to come with new approaches to overcome hurdles in clinical trial design and the selection of study endpoints.

“I’m quite sure we’ve been doing it wrong. If we had been doing it right, we would have found something that worked by now,” Celia Winchell, associate director for therapeutic...

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
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The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.