NCT02801643

Brief Summary

The present study would be the first to investigate the relationship between reward- and or social stimuli-induced dopamine (DA) release and neural function using a combined PET/fMRI approach. Data from this project conducted in healthy subjects will provide preliminary data for a larger grant application to study patient populations with known abnormalities in DA including schizophrenia, major depressive, substance use, and eating disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

June 13, 2016

Last Update Submit

April 16, 2018

Conditions

Keywords

PETdopaminefMRIreward

Outcome Measures

Primary Outcomes (3)

  • Dopamine receptor binding potential

    changes in dopamine receptor binding potential will be measured during and after a reward task or social stimulus task

    1-3 weeks

  • Resting state fMRI

    Resting state functional connectivity will be measured using fMRI

    1-3 weeks

  • Event-related potential (ERP) during reward

    ERP during a reward task is measured

    1-3 weeks

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

20 subjects (ages 18-45 years) will be included. Male and female representation will be about equal. No ethnic/racial/gender group is excluded.

You may qualify if:

  • Healthy men and women age 18-45 who have the capacity to consent to the protocol.
  • Ability to understand and follow instructions and oriented to name, time, and place.
  • A negative urine pregnancy and toxicology screen
  • Willingness to abstain from using aspirin, NSAIDs, or anticoagulants during the study

You may not qualify if:

  • Left-handed or ambidextrous
  • History of seizures
  • History of strokes
  • Clinically significant, uncontrolled liver, kidney, cardiac, or pulmonary disease
  • Terminal medical diagnosis consistent with survival \< 1 year
  • Serious mental impairment. Mini mental state exam of \< 23/30
  • Current or past DSM-IV Axis I or neurologic disorders
  • Actively abusing substances, including alcohol (regular alcohol use during the past 6 months equal to or greater than 16 cans of beer per week or equivalent; use of street drugs or regular tobacco use during the past 6 months)
  • Unstable medical condition (≥ 3 months), or serious medical illnesses during the past three months (e.g., serious infections)
  • Unexplained loss of consciousness; history of traumatic brain injury involving loss of consciousness greater than 2 minutes
  • Currently pregnant or breastfeeding, sexually active and of child-bearing potential and not using adequate contraceptive methods
  • Childbirth or miscarriage during past 6 months, breastfeeding within 6 months of recruitment
  • Allergic to latex and/or study pharmaceuticals
  • Diabetes and/or unable to fast for up to 7 hours
  • Unable to lie comfortably in the scanner for up to 4 consecutive hours
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Center

Stony Brook, New York, 11794, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 16, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations