Influence of Medication on Functional Connectivity

NCT03612713 | Completed Early Phase 1 Results DMC FDA Drug

• 3 other identifiers: 20000208571R21DA045969-011K01DA039299-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prescription Drug Abuse (Not Dependent)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Oxycodone Medication First

ACTIVE COMPARATOR

one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone

Drug: Oxycodone Medication First

Placebo First

PLACEBO COMPARATOR

one hour before fMRI scan participants will be given a single dose placebo.

Drug: Placebo First

Interventions

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.

Also known as: Oxycodone

Oxycodone Medication First

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.

Also known as: placebo

Placebo First

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Data Manager
• Organization: Yale University School of Medicine

Theresa.Babuscio@yale.edu

203-737-5430

Study Officials

• Sarah Yip, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 2, 2018
• Study Start: October 30, 2018
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Locations

US (1)