Influence of Medication on Functional Connectivity

Early Phase 1

Completed

• Conditions: Prescription Drug Abuse (Not Dependent)
• Interventions: Drug: Oxycodone Medication First; Drug: Placebo First

• Registration Number: NCT03612713
• Lead Sponsor: Yale University

Brief 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).

Study Timeline

• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Study Start: 2018-10-30
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02
• Results First Submitted: 2023-06-02
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Results First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxycodone Medication First	Oxycodone Medication First	one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone
Placebo First	Placebo First	one hour before fMRI scan participants will be given a single dose placebo.

Primary Outcome Measures

Name	Time	Method
Change in Functional Connectivity Following Oxycodone Administration	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.

Trial Locations

Locations (1)

Magnetic Resonance Research Center at The Anlyan Center Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States