Spaulding Clinical and FDA Study Contributing to Efforts to Address Opioid Crisis

WEST BEND, Wis.–(BUSINESS WIRE)–#clinicaltrials—Spaulding Clinical, a full-service Phase I clinical service provider, worked with the U.S. Food and Drug Administration (FDA) to conduct a clinical trial as a part of the FDA’s proactive effort to address the opioid crisis and reduce opioid overdoses and deaths. This trial evaluated whether two common psychotropic drugs would further decrease ventilation when combined with an opioid compared to an opioid alone. Early results indicated that one drug-opioid combination evaluated — paroxetine (an SSRI used to treat depression, anxiety and other conditions) plus oxycodone decreased ventilation compared with oxycodone use alone.

Opioids can decrease ventilatory response to hypercapnia, or excessive carbon dioxide in the bloodstream, which can cause severe respiratory depression or death. Since 2016, the FDA has required boxed warnings for both benzodiazepine and opioid products about increased respiratory depression risk with simultaneous use. Thus, this trial evaluated whether two other psychotropic drug-opioid combinations — paroxetine-oxycodone and quetiapine-oxycodone (compared to oxycodone with a placebo) — would cause similar effects. The results of the trial were published in the October Journal of the American Medical Association.

“Though further investigations are still needed, the early findings of this study — the first to test these combinations in humans — indicate that at least one additional drug used to treat anxiety (paroxetine) could pose similar risks for respiratory depression to those of benzodiazepin­es when either is used in combination with opioids,” said Spaulding Clinical Principal Investigator Jan Matousek, D.O. “While quetiapine combined with oxycodone did not cause this effect, this preliminary study conducted at Spaulding Clinical from January to May 2021 demonstrated that paroxetine combined with oxycodone, versus oxycodone with a placebo, did cause a greater risk of respiratory depression. Further testing is therefore essential to determine if common therapies increase the risk of respiratory depression when combined with opioids.”

Cassandra Erato, Spaulding Clinical CEO, commented, “This study was very complex, requiring extensive training for the breathing procedures and equipment and in-depth monitoring of participants in our intensive care unit, but the Spaulding Clinical research team with the FDA did an incredible job executing. We are proud to partner with the FDA to conduct this critical research that can help contribute to an important, greater effort.”

Further investigation is still needed to ascertain the longer-term effects and determine the clinical relevance of these findings.

About Spaulding Clinical Research

Founded in 2007, Spaulding Clinical is a full-service, state-of-the-art paperless Phase I clinical pharmacology unit. Our facility, originally a hospital, features fully integrated bedside electronic data capture and sets the standard for patient care. We specialize in IND-enabling clinical pharmacology studies, cardiovascular safety, and clinical proof of concept. We provide expertise on study design, offering in-house medical writing, clinical data management, biostatistics, project management, clinical laboratory, and PK/PD analysis. For high-quality data to inform your decisions, Think Spaulding First. To learn more, visit spauldingclinical.com.

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