Endogenous Opioid Mechanisms for Rejection Sensitivity
1 other identifier
observational
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2019
CompletedOctober 22, 2020
October 1, 2020
2.8 years
July 11, 2014
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mu-opioid binding potential
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).
within 30 days of informed consent
Secondary Outcomes (2)
fMRI blood-oxygen-level-dependent (BOLD) response
within 30 days of informed consent
Plasma cortisol
within 30 days of informed consent
Study Arms (1)
Healthy Controls
Healthy men and women ages 18-25 years
Eligibility Criteria
Healthy Controls
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stony Brook Universitylead
- University of Michigancollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Biospecimen
saliva, whole blood, blood plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David T Hsu, Ph.D.
Stony Brook University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 11, 2014
First Posted
July 15, 2014
Study Start
August 1, 2016
Primary Completion
June 6, 2019
Study Completion
June 6, 2019
Last Updated
October 22, 2020
Record last verified: 2020-10