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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT01577706
Eligibility Criteria:
Inclusion Criteria:
* Participants will be male volunteers between the ages of 21-45
* Non-smoking participants are preferred, but will admit those who smoke less than 5 cigarettes per day
* Participants must be able to read screening materials including consent form and give informed consent
Exclusion Criteria:
* Participants cannot meet DSM-IV criteria for lifetime and/or current mood, anxiety, psychotic, and alcohol/drug use disorders as identified by the SCID
* Participants cannot be taking any prescription medication (except oral contraceptives, certain short-term anti-fungal agents, and some topical creams for dermal conditions) or nutritional supplements
* Participants cannot be taking any psychotropic medications
* Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.
* Participants cannot have any conditions that are contraindicated for MRI
* Participants cannot have a family history of alcoholism
* Participants cannot have any abnormal blood chemistries/urinalysis results or any other medical condition that may affect drug disposition (e.g., Hepatitis C)
* Participants cannot have current or past cardiac problems, and they also cannot have a family history of sudden death or ventricular arrhythmia
* Participants who, in the investigators' judgment, will not likely be able to comply with the study protocol.
* Participants cannot have any clinically significant findings in the structural anatomic brain scans (per the MRI report read by a board-certified radiologist).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT01577706
Study Brief:
Protocol Section:
NCT01577706