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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PharmacofMRI of Anxiolytic Medications (Alprazolam)

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Drug: 0.25 mg alprazolam
* Drug: 1.0 mg alprazolam
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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. | Drug: 0.25 mg alprazolam<br>* 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.<br>* Other names: Xanax;|
| Active Comparator: 2<br>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. | Drug: 1.0 mg alprazolam<br>* 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.<br>* Other names: Xanax;|
| Placebo Comparator: Placebo<br>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. | Drug: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional magnetic resonance imaging, fMRI, alprazolam, anxiety disorders