Influence of Medication on Functional Connectivity

Prescription Drug Abuse (Not Dependent) Clinical Trial

Official title:

Influence of Medication on Functional Connectivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612713
• Other study ID #: 2000020857
• Secondary ID: 1R21DA045969-011
• Status: Completed
• Phase: Early Phase 1
• Start date: October 30, 2018
• Est. completion date: June 2, 2022

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prescription Drug Abuse (Not Dependent)
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Magnetic Resonance Research Center at The Anlyan Center Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.