Status:
COMPLETED
A Study of Neural Circuit Responses to Catechol-O-methyl Transferase (COMT) Inhibitors
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
University of California, Berkeley
United States Department of Defense
Conditions:
Impulsive Behavior
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
In this study, we seek to understand the effects of tolcapone, an FDA-approved COMT inhibitor, on reward choice and response inhibition, two measures we have previously shown to be altered in subjects...
Detailed Description
Drug consumption despite adverse consequences is a defining feature of human addiction (DSM-IV-TR, 2004). Impulsivity, a tendency to choose an immediate action despite delayed adverse consequences, is...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01158950
Start Date
March 1 2010
End Date
December 1 2018
Last Update
November 20 2020
Active Locations (2)
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1
University of California, Berkeley
Berkeley, California, United States, 94704
2
UCSF: Ernest Gallo Clinic and Research Center
Emeryville, California, United States, 94591