Dopaminergic Mechanisms Underlying Human Social Behavior

May 14, 2024 updated by: University of California, Berkeley

Dopaminergic Mechanisms Underlying Human Social Behavior: A Multimodal Approach

Developing theoretical, quantitative models of the basic cognitive mechanisms underlying human social decision-making, and understanding the influence of neuromodulators such as dopamine on these mechanisms, has important ramifications for both healthy and patient populations. In this proposal the investigators combine quantitative social measures, computational models, neuroimaging, and a pharmacological intervention to define the mechanisms of social decision-making.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A significant challenge for understanding social dysfunctions observed in mental illness is to link high-level theories of social behavior and cognition with the computations performed by brain circuits. Specifically, how does the brain translate social perception into social valuation, and how does such valuation influence social actions? Investigators propose to leverage recent developments in economic theory and cognitive neuroscience to bridge this divide using a computational, model-based approach. In this proposal, investigators hypothesize that social behavior is underpinned by brain mechanisms that are influenced by the neurotransmitter dopamine, and that these mechanisms can be captured by computational models that integrate internal representations of social experience, and parameters relevant to dopamine tone, to inform social actions. Social valuation thus critically, and quantitatively, depends upon both internal social representations and the neurochemistry of the actor within the social environment. To assess this hypothesis, investigators pursue two approaches to evaluate dopamine tone: one in which investigators use an FDA-approved medication, tolcapone, to influence dopamine metabolism, and one in which investigators perform Positron Emission Tomography (PET) imaging to measure dopamine release and baseline dopamine receptor D2/D3 occupancy. Investigators then apply a model of social valuation to subjects' behavior, and search for neural correlates of this valuation using functional MRI (fMRI). To this end, investigators bring together a group of experts in (1) the neuroeconomics and modeling of social and non-social decision-making, (2) cognitive neuroscience, (3) the pharmacology of frontostriatal circuits, and (4) neuroimaging. Investigators thus seek to broaden our understanding of the computations and circuits underlying social behavior. Moreover, investigators believe that a model-based understanding of these behaviors and neural circuits may guide more robust predictions of the effects of pharmacological manipulations on social valuation, and provide quantitative tools to assess the effects of such manipulations in patient populations, with possible therapeutic implications.

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.
Interventional

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.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94720
        • University of California, Berkeley

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Ages 18-40 and right-handed
  • Able to provide written informed consent
  • Normal or corrected-to-normal visual acuity
  • General good health as determined for tolcapone studies by screening provider (Dr. Kayser, Dr.Jagust, or other approved, licensed clinician)

Exclusion criteria:

  • Regular and/or scheduled use of other neuro- or psycho-active medications
  • Severe low blood pressure or uncontrolled high blood pressure
  • Intelligence quotient (IQ) < 70 as assessed by the Wechsler Test of Adult Reading (WTAR)
  • History of mild, moderate, or severe traumatic brain injury
  • History of brain surgery (i.e. violating brain parenchyma) or penetrating brain injury
  • Active alcohol dependence or alcohol abuse by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (within previous 30 days)
  • Active substance dependence or substance abuse by DSM-IV-TR criteria (excluding nicotine, but including marijuana, opiates, stimulants (cocaine, amphetamines), and hallucinogens within previous 30 days)
  • History of suicide attempt (last 5 years)
  • Clinically severe medical illness requiring treatment
  • History of brain tumor, stroke, demyelinating disease, encephalitis, or cerebral aneurysm rupture
  • Clinical diagnosis of Alzheimer's disease or other primary neurodegenerative disorder
  • Schizophrenia or other psychiatric disturbances

For Subjects Undergoing fMRI Scanning:

  • Contraindications to MRI (e.g. unremovable ferromagnetic metals, claustrophobia)
  • Inability to complete basic fMRI requirements (e.g. to make button presses and to minimize movement < 5mm)
  • Women of childbearing potential take a urine pregnancy test prior to scanning.

For Tolcapone Experiments:

  • Contraindications to tolcapone use, including liver function tests elevated more than 2.5 times above normal ranges, pregnancy, previous adverse reaction to tolcapone, significant liver or kidney impairment
  • Current use (within previous 30 days) of pharmacological agents with dopaminergic actions, including but not limited to levodopa/carbidopa, entacapone, tolcapone, amantadine, bromocriptine, pergolide, pramipexole, ropinirole, selegiline, isocarboxazid, phenelzine, tranylcypromine, clozapine, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, fluphenazine, haloperidol, perphenazine, pimozide, thiothixene, trifluoperazine, loxapine, molindone, chlorpromazine, mesoridazine, thioridazine, promethazine, dextroamphetamine, dexmethylphenidate, dextroamphetamine, or methylphenidate

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tolcapone
Tolcapone is a brain penetrant catechol-O-methyltransferase (COMT) inhibitor. It will be administered in a single 200mg dosage once in randomized, double-blind, counterbalanced fashion with a placebo.
Drug: Tolcapone 200 MG
Tolcapone is a brain penetrant catechol-O-methyltransferase (COMT) inhibitor. It will be administered in randomized, double-blind, counterbalanced fashion with a placebo.
Other: Functional Magnetic Resonance Imaging (fMRI)
FMRI provides an indirect and noninvasive measure of brain activity.
Placebo Comparator: Placebo
Placebo will be administered in a single pill once in randomized, double-blind, counterbalanced fashion with a placebo.
Other: Functional Magnetic Resonance Imaging (fMRI)
FMRI provides an indirect and noninvasive measure of brain activity.

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
Behavioral responses in neuroeconomic tasks
Time Frame: Up to 4 weeks
Subjects will make financial decisions involving themselves and another person in the context of model-based neuroeconomic games.
Up to 4 weeks
Blood oxygen level dependent (BOLD) activity
Time Frame: Up to 4 weeks
BOLD activity represents an indirect measure of brain activity, and will be correlated with behavioral task performance.
Up to 4 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.
University of California, Berkeley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Francisco
Lawrence Berkeley National Laboratory

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ming Hsu, PhD, University of California, Berkeley

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 (Actual)

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.
December 1, 2019

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 31, 2023

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 31, 2023

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).
December 18, 2019

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.
December 18, 2019

First Posted (Actual)

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.
December 20, 2019

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.
May 16, 2024

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.
May 14, 2024

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.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 231378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data and software code will be posted and shared via Open Science Foundation.

IPD Sharing Time Frame

We anticipate posting the data and code 2 years following completion of study on Open Science Foundation. All data and code will be anonymized to ensure confidentiality of participants. The data and code will be available indefinitely once posted.

IPD Sharing Access Criteria

Data and code will be public access once posted.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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