AOD Effects and ConsequencesCEBRA2NCT01577706

Spectroscopic Imaging at 4T: A Drug Challenge Study

A study testing Alprazolam and Dextroamphetamine in people with AOD Effects and Consequences, run by Mclean Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: AOD Effects and Consequences
What is being tested?: Alprazolam and Dextroamphetamine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

McLean Imaging Center, McLean Hospital
Belmont, Massachusetts, 02478-9106

Other trials in United States

About this study

Official title: Spectroscopic Imaging of GABA and Glutamate/Glutamine in Healthy Volunteers at 4T: A Double Blind, Crossover Drug Challenge Study

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.

Read the 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.

Conditions: AOD Effects and Consequences
Being tested: Alprazolam, Dextroamphetamine, Placebo
Keywords: GABA, glutamate, glutamine, spectroscopy, brain, imaging, alprazolam, dextroamphetamine, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlprazolamDrug
Also called Xanax
Alprazolam, gel-capsule, 1mg, single-dose, 1-day
DextroamphetamineDrug
Also called Dexedrine
Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
PlaceboOther
Placebo, gel-capsule, single-dose, 1-day

Study groups in NCT01577706
Study group	Role	What they receive
Alprazolam (A)	Active comparator	Alprazolam (Xanax), gel-capsule, 1mg, single-dose, 1-day Receives: Drug: Alprazolam
Dextroamphetamine (D)	Active comparator	Dextroamphetamine (Dexedrine), gel-capsule, 20mg, single-dose, 1-day Receives: Drug: Dextroamphetamine
Placebo (P)	Placebo comparator	Placebo gel-capsule, single-dose, 1-day Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
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
Measured: 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)
Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
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
Measured: 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)
Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
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
Measured: 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)
Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
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
Measured: 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)
Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
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
Measured: 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)
Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
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
Measured: 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)
Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
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
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Dec 2013

First posted16 Apr 2012 (estimated)
Study startJun 2013
Primary completionDec 2013
Study completionDec 2013

Why it stopped: lack of enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AOD Effects and ConsequencesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01577706
Sponsor's protocol ID: 2012P000197
Acronym: CEBRA2
Status last verified: Mar 2017
First submitted: 11 Apr 2012
Last updated: 4 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided: At present, there is no plan to share IPD data.

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spectroscopic Imaging of GABA and Glutamate/Glutamine in Healthy Volunteers at 4T: A Double Blind, Crossover Drug Challenge Study
ClinicalTrials.gov ID: NCT01577706
Acronym / sponsor ID: CEBRA2 / 2012P000197
Conditions: AOD Effects and Consequences
Keywords: GABA, glutamate, glutamine, spectroscopy, brain, imaging, alprazolam, dextroamphetamine
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of enrollment
Enrolment: 7 participants (actual)
Lead sponsor: Mclean HospitalUniversity, hospital or other
Study start: Jun 2013 (actual)
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 16 Apr 2012 (estimated)
Results: Posted 4 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Alprazolam (A)	Active comparator	Drug: AlprazolamAlprazolam (Xanax), gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine (D)	Active comparator	Drug: DextroamphetamineDextroamphetamine (Dexedrine), gel-capsule, 20mg, single-dose, 1-day
Placebo (P)	Placebo comparator	Other: PlaceboPlacebo gel-capsule, single-dose, 1-day

Who may qualify

Ages: 21 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlprazolamAlso: XanaxAlprazolam, gel-capsule, 1mg, single-dose, 1-day	Drug	Alprazolam (A)
DextroamphetamineAlso: DexedrineDextroamphetamine, gel-capsule, 20mg, single-dose, 1-day	Drug	Dextroamphetamine (D)
PlaceboPlacebo, gel-capsule, single-dose, 1-day	Other	Placebo (P)

Primary outcome

Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
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)
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
Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
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)
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
Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
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)
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
Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
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)
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
Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
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)
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
Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
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)
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
Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
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)
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

Results and safety

Results posted to the registry on 4 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dextroamphetamine, Alprazolam, Placebo Sequence	3	3
Alprazolam, Dextroamphetamine, Placebo Sequence	1	1
Placebo, Dextroamphetamine, Alprazolam Sequence	3	3

Primary outcome: Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge

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). Median (Inter-Quartile Range). Unit: percent change

Measure	Placebo n = 7	Alprazolam n = 7	Dextroamphetamine n = 7
t1 to t2: 45min-64min	-6.80 (-21.48 to 16.18)	23.57 (-1.97 to 64.94)	-12.51 (-21.04 to 21.22)
t1 to t3: 45min-83min	-2.63 (-7.82 to 16.87)	39.29 (29.17 to 50.69)	8.26 (-8.12 to 46.09)
t1 to t4: 45min-102min	10.01 (-25.15 to 25.52)	23.30 (17.75 to 58.61)	13.63 (-1.96 to 44.44)
t2 to t3: 64min-83min	4.47 (-16.73 to 52.66)	12.72 (1.46 to 37.76)	17.75 (5.02 to 30.20)
t3 to t4: 83min-102min	-6.32 (-20.28 to 32.66)	-2.10 (-10.90 to 9.20)	5.45 (-22.42 to 25.76)
t2 to t4: 64min-102min	15.44 (-16.72 to 47.92)	10.79 (-4.71 to 44.32)	24.16 (-0.26 to 38.62)

Primary outcome: Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge

Measure	Placebo n = 7	Alprazolam n = 7	Dextroamphetamine n = 7
t1 to t2: 45min-64min	-2.91 (-32.57 to 40.70)	43.17 (12.28 to 47.33)	5.28 (-6.26 to 39.08)
t1 to t3: 45min-83min	2.11 (-12.57 to 24.86)	43.09 (0.95 to 121.66)	17.06 (-8.04 to 58.61)
t1 to t4: 45min-102min	15.59 (-24.01 to 47.89)	44.26 (26.85 to 57.43)	14.68 (-24.68 to 80.77)
t2 to t3: 64min-83min	-0.58 (-31.51 to 49.01)	6.57 (-7.83 to 35.21)	13.40 (-1.90 to 14.04)
t3 to t4: 83min-102min	2.66 (-23.72 to 99.09)	3.53 (-30.30 to 42.90)	20.19 (-32.47 to 47.63)
t2 to t4: 64min-102min	5.10 (-21.73 to 45.14)	-4.57 (-25.72 to 28.48)	22.34 (3.56 to 32.70)

Primary outcome: Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge

Measure	Placebo n = 7	Alprazolam n = 7	Dextroamphetamine n = 7
t1 to t2: 45min-64min	-10.24 (-30.56 to 97.99)	4.38 (-22.54 to 60.19)	6.36 (-9.12 to 58.23)
t1 to t3: 45min-83min	-13.82 (-61.55 to -10.61)	13.44 (-18.74 to 56.65)	1.34 (-12.22 to 15.03)
t1 to t4: 45min-102min	-8.77 (-17.82 to 7.78)	58.49 (-56.01 to 98.58)	18.24 (-15.13 to 31.52)
t2 to t3: 64min-83min	-10.55 (-34.46 to 24.10)	14.55 (-2.21 to 48.14)	-6.70 (-27.30 to 15.62)
t3 to t4: 83min-102min	3.83 (-4.64 to 55.05)	32.81 (-45.86 to 44.54)	7.53 (-20.13 to 29.78)
t2 to t4: 64min-102min	-2.03 (-40.16 to 1.63)	19.68 (-43.21 to 54.55)	-20.20 (-26.64 to 15.38)

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

Primary outcome: Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge

Measure	Placebo n = 7	Alprazolam n = 7	Dextroamphetamine n = 7
t1 to t2: 45min-64min	6.09 (-14.53 to 23.67)	-0.51 (-26.89 to 22.96)	39.69 (-12.79 to 47.24)
t1 to t3: 45min-83min	-1.60 (-13.79 to 21.08)	1.90 (-4.50 to 13.63)	-10.29 (-21.14 to 21.33)
t1 to t4: 45min-102min	24.54 (-1.31 to 59.63)	21.95 (5.90 to 41.00)	22.35 (1.00 to 56.99)
t2 to t3: 64min-83min	2.15 (-20.41 to 30.46)	4.64 (-7.82 to 37.25)	-17.33 (-41.00 to 2.01)
t3 to t4: 83min-102min	21.76 (15.07 to 33.23)	10.78 (-8.66 to 33.39)	36.38 (19.58 to 65.32)
t2 to t4: 64min-102min	33.46 (3.73 to 50.47)	18.83 (3.59 to 41.72)	7.97 (-19.53 to 26.83)

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alprazolam	0 of 7 (0%)	0 of 7 (0%)	Not reported
Dextroamphetamine	0 of 7 (0%)	0 of 7 (0%)	Not reported
Placebo	0 of 7 (0%)	0 of 7 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. At present, there is no plan to share IPD data.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John E Jensen, Ph.D. principal investigator

Mclean Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Alprazolam and Dextroamphetamine in people with AOD Effects and Consequences, run by Mclean Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge (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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01577706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.