CompletedEarly Phase 1

Influence of Medication on Functional Connectivity

United States20 participantsStarted 2018-10-30

Plain-language summary

This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals

Who can participate

Age range

18 Years – 30 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

. males or females, ages 18-30
. for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
. ability to provide written, informed consent
. eligibility and willingness to participate in fMRI scanning and to receive oxycodone
. normal weight, as indicated by a body mass index (BMI) between 18.5 to 25

Exclusion criteria

. current DSM-5 Axis I disorder
. any psychotropic medication or medication known to interfere with metabolism of opioids
. medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
. known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
. not eligible for MRI scanning
. positive drug screen

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

Change in Functional Connectivity Following Oxycodone Administration

Timeframe: Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.

Trial details

NCT IDNCT03612713

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-02

Results submitted2023-06-02

View on ClinicalTrials.gov More Prescription Drug Abuse (Not Dependent) trials