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OpenTrials
Completed

NCT Number: NCT03612713

Influence of Medication on Functional Connectivity

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

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

New Haven, Connecticut, 06511, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • recent (past 6 months) medical or non-medical opioid-use
  • current or previous chronic pain disorder
  • significant lifetime use of prescription opioids (>7 days of consecutive medical use or nonmedical use on more than 5 occasions)

Treatment and study plan

Oxycodone Medication First

Drug

Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan.

Other names: Oxycodone

Placebo First

Drug

Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan.

Other names: placebo

Primary outcomes

  1. Change in Functional Connectivity Following Oxycodone Administration

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

    Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) between placebo and oxycodone fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2018
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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