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

Study Overview

• Status: Completed
• Conditions: Prescription Drug Abuse (Not Dependent)
• Intervention / Treatment: Drug: Oxycodone Medication First; Drug: Placebo First

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Magnetic Resonance Research Center at The Anlyan Center Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sarah Yip, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: 2000020857; 1K01DA039299-01A1 (U.S. NIH Grant/Contract); 1R21DA045969-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No