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Endogenous Opioid Mechanisms for Rejection Sensitivity

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ClinicalTrials.gov Identifier: NCT02189785
Recruitment Status : Recruiting
First Posted : July 15, 2014
Last Update Posted : January 2, 2018
Sponsor:
Collaborators:
University of Michigan
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Hsu, Stony Brook University

Brief Summary:
This project hypothesizes that the brain's opioid system determines rejection sensitivity, a personality trait that is a vulnerability factor and feature of several psychiatric disorders. This project will use positron emission tomography to measure the brain's opioid response to social rejection and acceptance in a nonclinical population with varying levels of rejection sensitivity. The results will provide the first major step towards understanding a neurotransmitter mechanism for rejection sensitivity, allowing for further investigation into predicting and treating its associated disorders.

Condition or disease
Rejection Sensitivity

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Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Endogenous Opioid Mechanisms for Rejection Sensitivity
Study Start Date : August 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort
Healthy Controls



Primary Outcome Measures :
  1. Mu-opioid binding potential [ Time Frame: within 30 days of informed consent ]
    This study will measure levels of radiotracer (carbon-11-labeled carfentanil) binding to the mu-opioid receptor in the brain using positron-emission tomography (PET). Primary regions of interest include: the amygdala, anterior insular cortex, anterior cingulate cortex, nucleus accumbens, and thalamus. All structures will be examined bilaterally. Differences in binding potential (Bmax/Kd) for the radiotracer will be compared across different experimental conditions (e.g., neutral, positive, negative social feedback).


Secondary Outcome Measures :
  1. fMRI blood-oxygen-level-dependent (BOLD) response [ Time Frame: within 30 days of informed consent ]
    This study will measure brain activation in response to social feedback and monetary reward. Primary regions of interest include: the amygdala, anterior insular cortex, and the nucleus accumbens. All structures will be examined bilaterally. Arbitrary units for fMRI BOLD are used to compare activation during one condition (e.g., neutral, baseline) vs. another condition (e.g., positive social feedback, monetary reward).

  2. Plasma cortisol [ Time Frame: within 30 days of informed consent ]
    This study will collect blood every 10 minutes during PET to measure changes in levels of plasma cortisol. Units are ug/dL.


Biospecimen Retention:   Samples With DNA
saliva, whole blood, blood plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Controls
Criteria

Inclusion Criteria:

  • Men and women age 18-25 (inclusive)
  • Right-handed
  • Native English speaker
  • Not currently in a romantic relationship
  • Willing and able to participate in a PET scan

Exclusion Criteria:

  • Not on hormonal birth control
  • Not pregnant
  • Consume less than 5 cigarettes per week and less than 14 alcoholic drinks per week, on average
  • No use of recreational or street drugs in the past two years (e.g. marijuana)
  • Willing to abstain from alcohol and/or tobacco for 48 hours
  • No major untreated medical problems
  • Never diagnosed with a psychiatric or neurological disorder
  • Potential problems with having an MRI scan (claustrophobia, metal objects, etc.)

Information from the National Library of Medicine

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): NCT02189785


Contacts
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Contact: Kristen Villalobos, BS (734) 232-0433 umconnectstudy@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kristen Villalobos, BS    734-232-0433    umconnectstudy@umich.edu   
Sub-Investigator: Stephan F Taylor, M.D.         
Sponsors and Collaborators
Stony Brook University
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: David T Hsu, Ph.D. Stony Brook University

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Responsible Party: David Hsu, Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT02189785     History of Changes
Other Study ID Numbers: R01MH102264 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017

Keywords provided by David Hsu, Stony Brook University:
social
rejection
acceptance
PET
opioid
fMRI
reward
exclusion

Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Analgesics, Opioid
Endorphins
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action