NCT02189785

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

2.8 years

First QC Date

July 11, 2014

Last Update Submit

October 19, 2020

Conditions

Keywords

socialrejectionacceptancePETopioidfMRIrewardexclusion

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

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva, whole blood, blood plasma

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • David T Hsu, Ph.D.

    Stony Brook University

    PRINCIPAL INVESTIGATOR

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

Locations