CompletedPhase 2/3

Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age

United States10 participantsStarted 2022-10-01

Plain-language summary

This study will establish the relationship between magnitude of opioid exposure and a pupillary measure referred to as PUAL (pupillary unrest in ambient light), in subjects aged 40-60. Previous investigation demonstrated that loss of PUAL was a sensitive, discriminative indicator of opioid toxicity and respiratory depression among subjects aged 20-40 years old. Population data indicate that pupil size and PUAL decline slightly with age. The investigators will explore whether PUAL proves to be a sensitive indicator of opioid exposure and respiratory depression in this older group.

Who can participate

Age range40 Years – 60 Years

SexALL

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Inclusion Criteria: * Healthy, BMI \< 35 kg/m2 Exclusion Criteria: * current or recent opioid use * opioid or other substance use disorder * known or suspected OSA or sleep disordered breathing * ischemic heart disease, heart failure or symptomatic arrhythmia history * ocular disease or previous eye surgery * active use of alpha adrenergic blockers, anticholinergic medications, * active use of antidepressant or mood stabilizing medications * active use of phosphodiesterase inhibitors * use of stimulant or appetite suppressant medications * active use of antihypertensive or antiarrhythmic medications * use of topical eye medications.

What they're measuring

Area Under the Time Concentration Curve (AUROC )

Timeframe: Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery

Trial details

NCT IDNCT05391555

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-03

Results submitted2024-09-06

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