Influence of Medication on Functional Connectivity

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

Detailed Description
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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).

Official Title
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Influence of Medication on Functional Connectivity

Conditions
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Prescription Drug Abuse (Not Dependent)

Intervention / Treatment
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* Drug: Oxycodone Medication First
* Drug: Placebo First


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone Medication First<br>one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone | Drug: Oxycodone Medication First<br>* 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.<br>* Other names: Oxycodone;|
| Placebo Comparator: Placebo First<br>one hour before fMRI scan participants will be given a single dose placebo. | Drug: Placebo First<br>* 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.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional connectivity following oxycodone administration | Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity between placebo and oxycodone fMRI scans will be assessed. | Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks. |