Influence of Medication on Functional Connectivity

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Prescription Drug Abuse (Not Dependent)

Treatments: Drug: Placebo First; Drug: Oxycodone Medication First

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03612713

1K01DA039299-01A1 (U.S. NIH Grant/Contract)

2000020857

1R21DA045969-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Oxycodone Medication First

Active Comparator group

Description:

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

Treatment:

Drug: Oxycodone Medication First

Placebo First

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo First