- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04205994
Dopaminergic Mechanisms Underlying Human Social Behavior
September 1, 2022 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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
70
Phase
- 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
- Name: Andrew Kayser, MD PHD
- Phone Number: 415-502-7333
- Email: dopamine@berkeley.edu
Study Locations
-
-
California
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Berkeley, California, United States, 94720
- Recruiting
- University of California, Berkeley
-
Contact:
- Ming Hsu, PHD
- Phone Number: 510-642-1686
- Email: dopamine@berkeley.edu
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-
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
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Tolcapone is a brain penetrant catechol-O-methyltransferase (COMT) inhibitor.
It will be administered in randomized, double-blind, counterbalanced fashion with a placebo.
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.
|
FMRI provides an indirect and noninvasive measure of brain activity.
|
What is the study measuring?
Primary Outcome Measures
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.
Investigators
- 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)
December 1, 2019
Primary Completion (ANTICIPATED)
December 31, 2023
Study Completion (ANTICIPATED)
December 31, 2023
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
December 18, 2019
First Posted (ACTUAL)
December 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 6, 2022
Last Update Submitted That Met QC Criteria
September 1, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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