Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT01158950
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.
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01158950
Study Brief:
Protocol Section:
NCT01158950