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Influence of Medication on Functional Connectivity | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

Influence of Medication on Functional Connectivity

NCT03612713•Yale University

Summary

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

Detailed Description

This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals (N=40, 20 male, 20 female). The objective of this research is to develop an understanding of factors that may influence individual variability on resting state functional connectivity in response to low-dose opioid administration with the longer term aim of understanding addictions vulnerability. Specifically, the proposed pilot research will explore the effects of single dose of oxycodone (15mg) on resting state functional connectivity and other common neuroimaging measures (e.g., diffusion MRI, structural MRI).

Eligibility

Age

18 - 30 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

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

Exclusion Criteria

•1. current DSM-5 Axis I disorder
•2. any psychotropic medication or medication known to interfere with metabolism of opioids
•3. medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
•4. known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
•6. positive drug screen
•7. recent (past 6 months) medical or non-medical opioid-use
•8. current or previous chronic pain disorder
•9. significant lifetime use of prescription opioids (\>7 days of consecutive medical use or nonmedical use on more than 5 occasions)

Locations (1)

Magnetic Resonance Research Center at The Anlyan Center Yale School of Medicine

New Haven, Connecticut, United States

Key Dates

Start Date

October 30, 2018

Primary Completion Date

June 2, 2022

Completion Date

June 2, 2022

Last Updated

March 8, 2024

Enrollment

ACTUAL participants

Conditions

Prescription Drug Abuse (Not Dependent)

Interventions

Oxycodone Medication First

DRUG

Placebo First

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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