Decision MakingEarly Phase 1NCT04205994
Dopaminergic Mechanisms Underlying Human Social Behavior
A Early Phase 1 study testing Tolcapone 200 MG and Functional Magnetic Resonance Imaging (fMRI) in people with Decision Making and Executive Function, run by University of California, Berkeley at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Decision Making, Executive Function, Dopamine
- What is being tested?
- Tolcapone 200 MG and Functional Magnetic Resonance Imaging (fMRI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 31 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
Official title: 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.
Read the 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.
- Conditions
- Decision Making, Executive Function, Dopamine
- Being tested
- Tolcapone 200 MG, Functional Magnetic Resonance Imaging (fMRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolcapone 200 MGDrug
Tolcapone is a brain penetrant catechol-O-methyltransferase (COMT) inhibitor. It will be administered in randomized, double-blind, counterbalanced fashion with a placebo.
Functional Magnetic Resonance Imaging (fMRI)Other
FMRI provides an indirect and noninvasive measure of brain activity.
| Study group | Role | What they receive |
|---|---|---|
| Tolcapone | Experimental | 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. Receives: Drug: Tolcapone 200 MG; Other: Functional Magnetic Resonance Imaging (fMRI) |
| Placebo | Placebo comparator | Placebo will be administered in a single pill once in randomized, double-blind, counterbalanced fashion with a placebo. Receives: Other: Functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral responses in neuroeconomic tasks
Subjects will make financial decisions involving themselves and another person in the context of model-based neuroeconomic games.
Measured: 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.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Dec 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Lawrence Berkeley National Laboratory
- Responsible party
- Sponsor
- Investigators
- Ming Hsu, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205994
- Sponsor's protocol ID
- 231378
- Status last verified
- May 2024
- First submitted
- 18 Dec 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data and software code will be posted and shared via Open Science Foundation.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Mechanisms Underlying Human Social Behavior: A Multimodal Approach
- ClinicalTrials.gov ID
- NCT04205994
- Acronym / sponsor ID
- 231378
- Conditions
- Decision Making, Executive Function, Dopamine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Lawrence Berkeley National Laboratory
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolcapone | Experimental | Drug: Tolcapone 200 MG, Other: Functional Magnetic Resonance Imaging (fMRI)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. |
| Placebo | Placebo comparator | Other: Functional Magnetic Resonance Imaging (fMRI)Placebo will be administered in a single pill once in randomized, double-blind, counterbalanced fashion with a placebo. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolcapone 200 MGTolcapone is a brain penetrant catechol-O-methyltransferase (COMT) inhibitor. It will be administered in randomized, double-blind, counterbalanced fashion with a placebo. | Drug | Tolcapone |
| Functional Magnetic Resonance Imaging (fMRI)FMRI provides an indirect and noninvasive measure of brain activity. | Other | Placebo, Tolcapone |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Yes. Anonymized data and software code will be posted and shared via Open Science Foundation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Hsu, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tolcapone 200 MG and Functional Magnetic Resonance Imaging (fMRI) in people with Decision Making and Executive Function, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral responses in neuroeconomic tasks (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.