Expired Study
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La Jolla, California 92037


Purpose:

The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function.


Study summary:

Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, alprazolam. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.


Criteria:

Inclusion Criteria: - Male, or female (not pregnant or intending to become pregnant during the study) - Between the ages of 18-30. - In good general health. - No specific contraindications to the drug being administered Exclusion Criteria: - Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety disorder - Subjects who meet criteria for substance abuse or dependence within the last 6 months - Subjects with an positive urine screen for illicit drugs - having clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the baseline visit - Patients who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, MAOI's) within the last year - subject is left-handed. - The subject suffers from claustrophobia, or phobia for injections or blood. - Magnetic Resonance Imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an I.U.D. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit).


Study is Available At:


Original ID:

UCSD IRB 060407 - A


NCT ID:

NCT00703885


Secondary ID:

R01MH075792


Study Acronym:


Brief Title:

PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam)


Official Title:

PharmacofMRI of Anxiolytic Medications (Alprazolam)


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

30 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Diego


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Crosso


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Actual


Overall Contact Information

Official Name:Murray B Stein, MD, MPH
Principal Investigator
University of California, San Diego

Study Dates

Start Date:January 2008
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:December 2014
Last Changed Date:December 19, 2014
First Received Date:June 20, 2008
First Results Date:June 19, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing
Time Frame:Same Day
Safety Issues:False
Description:Analysis not completed.
Outcome Type:Primary Outcome
Measure:Voxelwise Brain Imaging Data
Time Frame:Post-Rx Administration
Safety Issues:False
Description:Analysis of data not completed.

Study Interventions

Intervention Type:Drug
Name:0.25 mg alprazolam
Description:0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
Arm Name:1
Other Name:Xanax
Intervention Type:Drug
Name:1.0 mg alprazolam
Description:1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
Arm Name:2
Other Name:Xanax
Intervention Type:Drug
Name:placebo
Description:Placebo (liquid) to be administered 1 hour prior to fMRI scan Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
Arm Name:Placebo

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:0.25 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan. One-time, single dose. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
Study Arm Type:Active Comparator
Arm Name:2
Description:1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan One-time, single dose. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Inactive ingredient in liquid matching appearance and volume of the two active alprazolam dose comparators. Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Diego
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Simmons AN, Arce E, Lovero KL, Stein MB, Paulus MP. Subchronic SSRI administration reduces insula response during affective anticipation in healthy volunteers. Int J Neuropsychopharmacol. 2009 Sep;12(8):1009-20. doi: 10.1017/S1461145709990149. Epub 2009 Jun 23.
PMID:19545475
Reference Type:Reference
Citation:Aupperle RL, Ravindran L, Tankersley D, Flagan T, Stein NR, Simmons AN, Stein MB, Paulus MP. Pregabalin influences insula and amygdala activation during anticipation of emotional images. Neuropsychopharmacology. 2011 Jun;36(7):1466-77. doi: 10.1038/npp.2011.32. Epub 2011 Mar 23.
PMID:21430645
Reference Type:Reference
Citation:Aupperle RL, Tankersley D, Ravindran LN, Flagan T, Stein NR, Stein MB, Paulus MP. Pregabalin effects on neural response to emotional faces. Front Hum Neurosci. 2012 Mar 27;6:42. doi: 10.3389/fnhum.2012.00042. eCollection 2012.
PMID:22470326

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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