Overview

Spectroscopic Imaging at 4T: A Drug Challenge Study

Status:
Terminated
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
Male
Summary
An advanced technique for rapid magnetic resonance proton spectroscopic imaging (1H-MRSI) will be employed in a drug challenge study in healthy volunteers to spatially map and measure acute changes in the brain chemicals GABA, glutamate and glutamine after administration of a drug. Three condition will be tested in a double-blind fashion, i)depressant, ii)stimulant, iii)placebo. It is hypothesized that unique and reproducible spatial and directional metabolic response patterns will be observed, unique to each condition within the brain.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mclean Hospital
Treatments:
Alprazolam
Dextroamphetamine
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).