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 range

40 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Opioid Toxicity trials