The Impact of Reward-induced Dopamine Release on Functional Connectivity: a Combined PET/fMRI Study

April 16, 2018 updated by: David Hsu, Stony Brook University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Aim 1. To test the relationship between reward-induced dopamine (DA) release on changes in resting state functional connectivity (RSFC) in healthy subjects. In 20 healthy adults, the investigators will examine DA release (measured using positron emission tomography, PET) in the ventral striatum, thalamus, and prefrontal cortex, as previously described. Before and after the task the investigators will examine RSFC (measured using functional magnetic resonance imaging, fMRI) between these structures, which have been shown to form functional pathways serving motivation and emotion regulation in rodents and nonhuman primates. The investigators hypothesize that DA release will impact the functional relationship between these and other structures as determined by changes in RSFC.

Aim 2. To examine the relationship between dopamine release and the Reward Positivity (RewP) potential. Subjects will be presented with the option to participate in an event-related potential (ERP) study. The investigators will correlate the amount of DA release with the amplitude of the RewP potential, an ERP that is enhanced in reward versus non-reward circumstances. Based on previous studies, the investigators hypothesize that RewP amplitude will positively correlate with dopamine release in the nucleus accumbens.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Left-handed or ambidextrous
  2. History of seizures
  3. History of strokes
  4. Clinically significant, uncontrolled liver, kidney, cardiac, or pulmonary disease
  5. Terminal medical diagnosis consistent with survival < 1 year
  6. Serious mental impairment. Mini mental state exam of < 23/30
  7. Current or past DSM-IV Axis I or neurologic disorders
  8. 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)
  9. Unstable medical condition (≥ 3 months), or serious medical illnesses during the past three months (e.g., serious infections)
  10. Unexplained loss of consciousness; history of traumatic brain injury involving loss of consciousness greater than 2 minutes
  11. Currently pregnant or breastfeeding, sexually active and of child-bearing potential and not using adequate contraceptive methods
  12. Childbirth or miscarriage during past 6 months, breastfeeding within 6 months of recruitment
  13. Allergic to latex and/or study pharmaceuticals
  14. Diabetes and/or unable to fast for up to 7 hours
  15. Unable to lie comfortably in the scanner for up to 4 consecutive hours
  16. Would receive a total of over 5 rems to a radiosensitive organ (bone marrow, gonads, lens of the eye) or 15 rems to any other organ or to the body as a whole during a 12 month period
  17. Contraindications for MRI including neurostimulators, implanted medical devices, metal in the body, claustrophobia, weight over 440 pounds, and girth size incompatible for scanner bore.
  18. Participation in a similar Social Feedback Task within 2 months of the start of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dopamine receptor binding potential
Time Frame: 1-3 weeks
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
Time Frame: 1-3 weeks
Resting state functional connectivity will be measured using fMRI
1-3 weeks
Event-related potential (ERP) during reward
Time Frame: 1-3 weeks
ERP during a reward task is measured
1-3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PET/MR Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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