Dopaminergic Mechanisms Underlying Human Social Behavior

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Decision Making, Executive Function, Dopamine

In brief

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.

Key facts

Study ID

NCT04205994

Run by

University of California, Berkeley

People needed

70

Starts

2019-12-01

Expected to finish

2023-12-31

Last updated by the study team

2024-05-16

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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