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

NCT ID: NCT02929485

Last Updated: 2021-11-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-01-31

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.

Detailed Description

The investigators aim to understand how the brain's dopamine system impacts monetary and food-related decision making. The investigators aim to use tolcapone and bromocriptine due to the temporary change in the levels of dopamine in the brain. The investigators also aim to determine if genetics, personality traits, or a family history of alcoholism change how these drugs affect decision making.

Conditions

Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Experimental: Tolcapone

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

Group Type: EXPERIMENTAL

Tolcapone

Intervention Type: DRUG

Tolcapone 200mg (single dose) administered at study visit

Comparator: Placebo

Drug: Placebo for tolcapone administered at study visit

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (200mg) administered at study visit

Experimental: Bromocriptine

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

Group Type: EXPERIMENTAL

Bromocriptine

Intervention Type: DRUG

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

Interventions

Tolcapone

Tolcapone 200mg (single dose) administered at study visit

Intervention Type: DRUG

Placebo

Placebo (200mg) administered at study visit

Intervention Type: DRUG

Bromocriptine

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

Intervention Type: DRUG

Other Intervention Names

Tasmar; Parlodel

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Subject has a pacemaker, defibrillator, stent, or any metal implants related to heart/blood flow problems.
• Subject has worked with metals (ie. metallurgy, metal shaving, welding, soldering, etc).
• Subject has been wounded with anything metal (bullet, shrapnel or metal filling).
• Has ever gotten a piece of metal in the eye.
• Has tattoos done with ink containing metal or permanent eyeliner.
• Wears color contact lenses.
• Has a hearing problem or hearing aid, cochlear implant or past ear surgery.
• Has any irremovable dental bridges, dental plates, metal caps or any other non-removable metal in the mouth.
• The subject is claustrophobic.
• The subject is pregnant. (women only)
• Has a IUD. (women only)
• Significantly overweight.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Kayser, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, Berkeley

Berkeley, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

2011-11-3748

Identifier Type: -

Identifier Source: org_study_id