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

• Status: Completed
• Trial end date: 2018-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Berkeley; University of California, San Francisco
• Collaborators: University of California, Berkeley; University of California, San Francisco
• Treatments: Bromocriptine; Catechol O-Methyltransferase Inhibitors; Dopamine; Dopamine Agents; Dopamine Agonists; Tolcapone

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.

MRI Exclusion Criteria:

• 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.