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Phase Pilot

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  • Study HIC#:2000020857
  • Last Updated:07/15/2021

Brief Summary:

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

  • Age18 years - 30 years
  • GenderBoth
  • Start Date09/30/2018
  • End Date09/29/2020

Trial Purpose and Description

This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals. 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/acetaminophen 7.5/325mg on resting state functional connectivity and other common neuroimaging measures (e.g., diffusion MRI, structural MRI). This ┬┐proof-of-concept┬┐ work will be used as the basis for subsequent Federal and/or non-Federal grant applications.

Eligibility Criteria

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
  5. not eligible for MRI scanning
  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)

Principal Investigator

Sub-Investigators

  • Deepa Camenga

For more information about this study, contact the Help us Discover team on: