Influence of Medication on Functional Connectivity

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2022-06-02

Brief Summary

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

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Detailed Description

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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).

Conditions

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Prescription Drug Abuse (Not Dependent)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oxycodone Medication First

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

Group Type ACTIVE_COMPARATOR

Oxycodone Medication First

Intervention Type 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.

Placebo First

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

Group Type PLACEBO_COMPARATOR

Placebo First

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Oxycodone placebo

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes