CEBRA2: Spectroscopic Imaging at 4T: A Drug Challenge Study

• Sponsor: Mclean Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01577706
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 3
• Actual Duration (Months): 6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
AOD Effects and Consequences	Drug: Alprazolam; Drug: Dextroamphetamine; Other: Placebo	N/A

Detailed Description

Proton magnetic resonance spectroscopy (1H MRS) is a powerful tool for assessing neurochemistry non-invasively in vivo. However, the primary shortcoming in most studies is the lack of spatial coverage afforded by the typical single-voxel design. Limits on participant tolerance and financial resources restrict single-voxel studies to an examination of one or two carefully chosen voxels per scan, thus inadequately addressing the question of focal vs. global pathophysiology. A secondary shortcoming is that most studies report on either GABA or glutamate-glutamine (Glu-Gln) due to the technically demanding spectral-editing techniques that must be implemented in order to resolve and quantify those metabolites with any accuracy.

1H MRS imaging (MRSI) can partially overcome these limitations by providing a global picture of brain chemistry rather than just the focal snapshot afforded by the single-voxel design. However, the scan time necessary for collecting enough data for adequate spatial resolution and signal-to-noise, particularly if also using specialized spectral-editing techniques, is still too lengthy. We recently developed a method that combines Spectroscopic Imaging with the MEGAPRESS-based difference-editing acquisition for optimal GABA detection as well as for optimal detection of Glu and Gln. This MEGACSI sequence will permit us to obtain the maximum amount of neurochemical information in a clinically sound scan time, while using the current state-of-the-art MRS editing methods for optimal detection of GABA, Glu, and Gln.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Spectroscopic Imaging of GABA and Glutamate/Glutamine in Healthy Volunteers at 4T: A Double Blind, Crossover Drug Challenge Study
• Actual Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Alprazolam (A) Alprazolam (Xanax), gel-capsule, 1mg, single-dose, 1-day	Drug: Alprazolam; Alprazolam, gel-capsule, 1mg, single-dose, 1-day; Other Names: Xanax
Active Comparator: Dextroamphetamine (D) Dextroamphetamine (Dexedrine), gel-capsule, 20mg, single-dose, 1-day	Drug: Dextroamphetamine; Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day; Other Names: Dexedrine
Placebo Comparator: Placebo (P) Placebo gel-capsule, single-dose, 1-day	Other: Placebo; Placebo, gel-capsule, single-dose, 1-day

Outcome Measures

Primary Outcome Measures

1. Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge [from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)]

   The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint

2. Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge [from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)]

   The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint

3. Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge [from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)]

   The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint

4. Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge [from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)]

   The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint

5. Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge [from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)]

   The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint

6. Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge [from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)]

   The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint

7. Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge [from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)]

   The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McLean Imaging Center, McLean Hospital	Belmont	Massachusetts	United States	02478-9106

Sponsors and Collaborators

• Mclean Hospital

Investigators

• Principal Investigator: John E Jensen, Ph.D., Mclean Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Eric Nestler Jensen, Associate Biophysicist, Director-High Field Imaging and Spectroscopy Program, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT01577706
• Other Study ID Numbers: 2012P000197
• First Posted: Apr 16, 2012
• Last Update Posted: Apr 4, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by John Eric Nestler Jensen, Associate Biophysicist, Director-High Field Imaging and Spectroscopy Program, Mclean Hospital: GABA; glutamate; glutamine; spectroscopy; brain; imaging; alprazolam; dextroamphetamine; placebo
• Additional relevant MeSH terms: Alprazolam; Dextroamphetamine

Study Results

Participant Flow

Arm/Group Title	Dextroamphetamine, Alprazolam, Placebo Sequence	Alprazolam, Dextroamphetamine, Placebo Sequence	Placebo, Dextroamphetamine, Alprazolam Sequence
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day Placebo: single-dose, 1-day
Period Title: First Intervention (1 Day)
STARTED	3	1	3
COMPLETED	3	1	3
NOT COMPLETED	0	0	0
Period Title: First Intervention (1 Day)
STARTED	3	1	3
COMPLETED	3	1	3
NOT COMPLETED	0	0	0
Period Title: First Intervention (1 Day)
STARTED	3	1	3
COMPLETED	3	1	3
NOT COMPLETED	0	0	0
Period Title: First Intervention (1 Day)
STARTED	3	1	3
COMPLETED	3	1	3
NOT COMPLETED	0	0	0
Period Title: First Intervention (1 Day)
STARTED	3	1	3
COMPLETED	3	1	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Overall Participants	7
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.9 (7.6)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	7 100%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
Description	The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint
Time Frame	from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Alprazolam	Dextroamphetamine
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Measure Participants	7	7	7
t1 to t2: 45min-64min	-6.80	23.57	-12.51
t1 to t3: 45min-83min	-2.63	39.29	8.26
t1 to t4: 45min-102min	10.01	23.30	13.63
t2 to t3: 64min-83min	4.47	12.72	17.75
t3 to t4: 83min-102min	-6.32	-2.10	5.45
t2 to t4: 64min-102min	15.44	10.79	24.16

2. Primary Outcome

Title	Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
Description	The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint
Time Frame	from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Alprazolam	Dextroamphetamine
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Measure Participants	7	7	7
t1 to t2: 45min-64min	-2.91	43.17	5.28
t1 to t3: 45min-83min	2.11	43.09	17.06
t1 to t4: 45min-102min	15.59	44.26	14.68
t2 to t3: 64min-83min	-0.58	6.57	13.40
t3 to t4: 83min-102min	2.66	3.53	20.19
t2 to t4: 64min-102min	5.10	-4.57	22.34

3. Primary Outcome

Title	Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
Description	The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint
Time Frame	from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Outcome Measure Data

Analysis Population Description

One participant is missing GABA level at t4 while on Placebo, and one participant is missing GABA level at t2 while on Alprazolam.

Arm/Group Title	Placebo	Alprazolam	Dextroamphetamine
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Measure Participants	7	7	7
t1 to t2: 45min-64min	-10.24	4.38	6.36
t1 to t3: 45min-83min	-13.82	13.44	1.34
t1 to t4: 45min-102min	-8.77	58.49	18.24
t2 to t3: 64min-83min	-10.55	14.55	-6.70
t3 to t4: 83min-102min	3.83	32.81	7.53
t2 to t4: 64min-102min	-2.03	19.68	-20.20

4. Primary Outcome

Title	Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
Description	The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint
Time Frame	from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Alprazolam	Dextroamphetamine
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Measure Participants	7	7	7
t1 to t2: 45min-64min	6.09	-0.51	39.69
t1 to t3: 45min-83min	-1.60	1.90	-10.29
t1 to t4: 45min-102min	24.54	21.95	22.35
t2 to t3: 64min-83min	2.15	4.64	-17.33
t3 to t4: 83min-102min	21.76	10.78	36.38
t2 to t4: 64min-102min	33.46	18.83	7.97

5. Primary Outcome

Title	Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
Description	The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint
Time Frame	from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Outcome Measure Data

Analysis Population Description

One participant ismissing GABA level at t4 while on Dextroamphetamine

Arm/Group Title	Placebo	Alprazolam	Dextroamphetamine
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Measure Participants	7	7	7
t1 to t2: 45min-64min	6.55	2.72	-3.61
t1 to t3: 45min-83min	7.26	19.20	14.63
t1 to t4: 45min-102min	8.39	4.54	30.23
t2 to t3: 64min-83min	-7.13	16.51	14.95
t3 to t4: 83min-102min	2.87	-1.78	1.60
t2 to t4: 64min-102min	12.69	12.12	15.51

6. Primary Outcome

Title	Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
Description	The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint
Time Frame	from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Outcome Measure Data

Analysis Population Description

One participant is missing GABA level at t4 while on Dextroamphetamine.

Arm/Group Title	Placebo	Alprazolam	Dextroamphetamine
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Measure Participants	7	7	7
t1 to t2: 45min-64min	18.63	-9.44	38.78
t1 to t3: 45min-83min	-3.97	3.03	67.41
t1 to t4: 45min-102min	-1.53	33.58	37.92
t2 to t3: 64min-83min	-9.88	17.08	21.02
t3 to t4: 83min-102min	11.46	-0.82	-5.96
t2 to t4: 64min-102min	10.15	35.96	14.20

7. Primary Outcome

Title	Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
Description	The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint
Time Frame	from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Outcome Measure Data

Analysis Population Description

One participant is missing GABA level at t4 while on Dextroamphetamine. Another participant is missing GABA levels both at t2 and t4 while on Dextroamphetamine. Another participant is missing GABA levels at both t2 and t4 while on Alprazolam.

Arm/Group Title	Placebo	Alprazolam	Dextroamphetamine
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Measure Participants	7	7	7
t1 to t2: 45min-64min	14.93	-1.45	2.09
t1 to t3: 45min-83min	21.26	24.29	-23.17
t1 to t4: 45min-102min	48.95	31.06	30.23
t2 to t3: 64min-83min	-13.91	-4.86	18.52
t3 to t4: 83min-102min	10.85	23.34	70.88
t2 to t4: 64min-102min	26.78	19.53	31.58

Adverse Events

Time Frame	Adverse events were monitored throughout the entire clinical study which (including a no-cost extension) was of 1 year, 6 month duration, until the study closed to recruitment.
Arm/Group Title	Alprazolam		Dextroamphetamine		Placebo
Arm/Group Description	Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day		Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day		Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo, single-dose, 1-day
All Cause Mortality
	Alprazolam		Dextroamphetamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Alprazolam		Dextroamphetamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Alprazolam		Dextroamphetamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.