An Early Phase 1 interventional study of Tolcapone 200 MG and Functional Magnetic Resonance Imaging (fMRI) in Decision Making, Executive Function and Dopamine, sponsored by University of California, Berkeley. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University of California, Berkeley · Early Phase 1, Interventional, and Basic science
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.
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.
University of California, Berkeley is the lead sponsor of 106 studies on the registry; 18 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion criteria:
For Subjects Undergoing fMRI Scanning:
For Tolcapone Experiments:
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 · Other: Functional Magnetic Resonance Imaging (fMRI)
Placebo will be administered in a single pill once in randomized, double-blind, counterbalanced fashion with a placebo.
Other: Functional Magnetic Resonance Imaging (fMRI)
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.
Behavioral responses in neuroeconomic tasks
Subjects will make financial decisions involving themselves and another person in the context of model-based neuroeconomic games.
Time frame: Up to 4 weeks
Blood oxygen level dependent (BOLD) activity
BOLD activity represents an indirect measure of brain activity, and will be correlated with behavioral task performance.
Time frame: Up to 4 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized data and software code will be posted and shared via Open Science Foundation.
Supporting information: Analytic code
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of California, Berkeley