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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02929485
Enrollment
0
Registered
2016-10-11
Start date
2013-07-31
Completion date
2018-01-31
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction

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.

Interventions

DRUGBromocriptine

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

DRUGTolcapone

Tolcapone 200mg (single dose) administered at study visit

DRUGPlacebo

Placebo (200mg) administered at study visit

Sponsors

University of California, San Francisco
CollaboratorOTHER
University of California, Berkeley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measure Effects of Placebo,Tolcapone, Bromocriptine on Reaction Time3 weeksParticipants will play the Dictator Game. Behavioral responses to the game during each arm (placebo, tolcapone, and bromocriptine) will be measured by subject reaction time .
Measure Effects of Placebo,Tolcapone, Bromocriptine on Accuracy3 weeksParticipants 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).

Secondary

MeasureTime frameDescription
Measure Observed Changes in Resting State Neural Activity3 weeksResting-state data will be processed off-line using neuroimaging analysis software according to standard procedures for image slice-timing correction, realignment, normalization and smoothing. Changes in regional brain activity will be measured during the placebo, tolcapone and bromocriptine conditions.
Measure Observed Changes in Task Dependent Neural Activity3 weeksTask dependent fMRI data will be processed off-line using neuroimaging analysis software according to standard procedures for image slice-timing correction, realignment, normalization and smoothing. Changes in task dependent brain activity will be measured during the placebo, tolcapone and bromocriptine conditions.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026