Dopaminergic Modulation of Frontostriatal Function With a Dopamine Agonist and COMT Inhibitor

NCT02929485 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2011-11-3748
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the investigators are looking at how people make decisions about reward-related items, both monetary and food related after taking either the dopamine agonist bromocriptine or the COMT inhibitor tolcapone, in healthy control subjects. Subjects will fill self-report questionnaires and undergo an MRI scan.

Conditions

Addiction

Outcome Measures

Primary Outcomes (2)

• Measure Effects of Placebo,Tolcapone, Bromocriptine on Reaction Time

  Participants will play the Dictator Game. Behavioral responses to the game during each arm (placebo, tolcapone, and bromocriptine) will be measured by subject reaction time .

  3 weeks

• Measure Effects of Placebo,Tolcapone, Bromocriptine on Accuracy

  Participants will play the Dictator Game. Behavioral responses to the game during each arm (placebo, tolcapone, and bromocriptine) will be measured by subject accuracy (correct or incorrect responses).

  3 weeks

Secondary Outcomes (2)

• Measure Observed Changes in Resting State Neural Activity

  3 weeks

• Measure Observed Changes in Task Dependent Neural Activity

  3 weeks

Study Arms (3)

Experimental: Tolcapone

EXPERIMENTAL

Drug: Tolcapone 200mg (single dose) administered at study visit

Drug: Tolcapone

Comparator: Placebo

PLACEBO COMPARATOR

Drug: Placebo for tolcapone administered at study visit

Drug: Placebo

Experimental: Bromocriptine

EXPERIMENTAL

Drug: Bromocriptine 1.25mg (single dose) administered at study visit

Drug: Bromocriptine

Interventions

Tolcapone DRUG

Tolcapone 200mg (single dose) administered at study visit

Also known as: Tasmar

Experimental: Tolcapone

Placebo DRUG

Placebo (200mg) administered at study visit

Comparator: Placebo

Bromocriptine DRUG

Drug: Bromocriptine 1.25 mg (single dose) administered at study visit

Also known as: Parlodel

Experimental: Bromocriptine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50 years.
• Subject is right-handed.
• If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device (IUD), hormonal birth control or barrier method).
• Subject is able to read and speak English.
• Subject is a high school graduate.
• Subject is able and willing to provide written and informed consent.
• Subject is able to understand and follow the instructions of the investigator, and understand all ratings scales.
• Subject is in good health.

You may not qualify if:

• Using cocaine, stimulants (other than THC, nicotine, \& caffeine)amphetamines, hallucinogens, "ecstasy", opiates, sedatives, pain pills, sleeping pills or other psychoactive drugs within two weeks of the start of the study OR more than 10 times in the last year.
• Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol.
• Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and physical exam performed or reviewed by the study physician.
• Subject has a history of major alcohol related complications within the proceeding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.)
• Liver function test ≥ 3 times normal upper limit.
• BAC level \> 0.05% at the beginning of screening visit (within margin of error of detection).
• Has a neurological dysfunction or psychiatric disorder.
• Has severe low blood pressure.
• Has uncontrolled high blood pressure.
• Regular use of any of the drugs on the tolcapone or entacapone contraindications list OR within 2 weeks of drug administration.
• Regular use of SSRIs.
• Has an allergy or intolerance to tolcapone or entacapone.
• Subject has received an investigational drug within 30 days of screening visit.
• Subject is considered unsuitable for the study in the opinion of the investigator or study physician for any other reason.
• The subject has metal (metal plates, pins, wires or screws, artificial limb, joint replacement or anything that might have been inserted during an operation) in his/her body.

Sponsors & Collaborators

• University of California, Berkeley: lead
• University of California, San Francisco: collaborator

Study Sites (2)

University of California, Berkeley

Berkeley, California, 94704, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Tolcapone; Bromocriptine

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitrophenols; Phenols; Ketones; Nitro Compounds; Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrew Kayser, MD,PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 11, 2016
• Study Start: July 1, 2013
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)