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

Age range18 Years – 30 Years

SexALL

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

✓. 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

✕. 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
✕. recent (past 6 months) medical or non-medical opioid-use
✕. current or previous chronic pain disorder

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.

NCT IDNCT03612713

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-02

Results submitted2023-06-02