Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation
Status:
Completed
Trial end date:
2021-05-25
Target enrollment:
Participant gender:
Summary
Opioids can decrease breathing and co-administration of benzodiazepines with opioids can
further decrease breathing. It is unknown whether certain other drugs also decrease breathing
when co-administered with opioids. The objective of this study is to determine whether
certain drugs combined with an opioid decrease breathing compared to breathing with an opioid
alone.
In order to assess this, this study will utilize the Read Rebreathing method, where study
participants breathe increased levels of oxygen and carbon dioxide. The increased levels of
carbon dioxide cause the study participants to increase breathing. This increased breathing
response can be decreased by opioids and benzodiazepines, and potentially other drugs. Using
this procedure, low doses of opioids or benzodiazepines can be administered that have
minimal-to-no effects on breathing when study participants are going about normal activities
breathing room air, however breathing increases less than expected as carbon dioxide levels
are increased. This study will also obtain quantitative pupillometry measurements before and
after each rebreathing assessment to allow for comparisons of pupillary changes to
ventilatory changes when subjects receive different drugs and drug combinations.
This study includes three parts: A Lead-In Reproducibility Phase and two main parts (Part 1
and Part 2). The Lead-In Reproducibility Phase will measure the variability between study
participants and between repeated uses of the method in the same study participant within a
day and between days. Part 1 will study an opioid alone, benzodiazepine alone, and their
combination to show the methodology will detect changes in breathing at low doses of the
drugs that are known to affect breathing. Part 2 will assess whether two drugs, selected due
to their effects on breathing in a nonclinical model, decrease the breathing response when
combined with an opioid compared to when an opioid is administered alone.
Phase:
Phase 1
Details
Lead Sponsor:
Food and Drug Administration (FDA)
Collaborators:
Leiden University Leiden University Medical Center Spaulding Clinical Research LLC