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Influence of Medication on Functional Connectivity

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ClinicalTrials.gov Identifier: NCT03612713
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Prescription Drug Abuse (Not Dependent) Drug: Oxycodone Medication First Drug: Placebo First Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Influence of Medication on Functional Connectivity
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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Arms and Interventions
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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 Name: 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 Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in functional connectivity following oxycodone administration [ Time Frame: Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks. ]
    Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity between placebo and oxycodone fMRI scans will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612713


Contacts
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Contact: Monica Holler, BA (203) 974-7356 monica.holler@yale.edu

Locations
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United States, Connecticut
Magnetic Resonance Research Center at The Anlyan Center Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Principal Investigator: Sarah Yip, PhD         
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Sarah Yip, PhD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03612713     History of Changes
Other Study ID Numbers: 20000 20857
1R21DA045969-01 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019

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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
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents