Spectroscopic Imaging at 4T: A Drug Challenge Study
Stopped early · Not applicable · Has a placebo group
Conditions studied: AOD Effects and Consequences
In brief
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.
Key facts
- Study ID
- NCT01577706
- Run by
- Mclean Hospital
- People needed
- 7
- Starts
- 2013-06-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2017-04-04
Who can join
Age: 21 and older, up to 45. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- McLean Imaging Center, McLean Hospital — Belmont, Massachusetts, United States
Full record on ClinicalTrials.gov
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