Dopaminergic Mechanisms Underlying Human Social Behavior

NCT04205994 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 231378
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. In this proposal the investigators combine quantitative social measures, computational models, neuroimaging, and a pharmacological intervention to define the mechanisms of social decision-making.

Conditions

Decision Making; Executive Function; Dopamine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

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.

Other: Functional Magnetic Resonance Imaging (fMRI)

Interventions

Tolcapone 200 MG DRUG

Tolcapone is a brain penetrant catechol-O-methyltransferase (COMT) inhibitor. It will be administered in randomized, double-blind, counterbalanced fashion with a placebo.

Tolcapone

Functional Magnetic Resonance Imaging (fMRI) OTHER

FMRI provides an indirect and noninvasive measure of brain activity.

Placebo; Tolcapone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• University of California, Berkeley: lead
• University of California, San Francisco: collaborator
• Lawrence Berkeley National Laboratory: collaborator

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

MeSH Terms

Interventions

Tolcapone

Intervention Hierarchy (Ancestors)

Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitrophenols; Phenols; Ketones; Nitro Compounds

Study Officials

• Ming Hsu, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: December 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• 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.
• Access Criteria: Data and code will be public access once posted.

Locations

US (1)