Executive Function Clinical Trial
Official title:
Dopaminergic Mechanisms Underlying Human Social Behavior: A Multimodal Approach
Verified date | May 2024 |
Source | University of California, Berkeley |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Berkeley | Berkeley | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Berkeley | Lawrence Berkeley National Laboratory, University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Behavioral responses in neuroeconomic tasks | Subjects will make financial decisions involving themselves and another person in the context of model-based neuroeconomic games. | Up to 4 weeks | |
Primary | Blood oxygen level dependent (BOLD) activity | BOLD activity represents an indirect measure of brain activity, and will be correlated with behavioral task performance. | Up to 4 weeks |
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