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

• Status: Not yet recruiting
• Trial end date: 2023-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Remifentanil

Criteria

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.