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

University of California, San Diego16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Anxiety Disorders

Interventions

0.25 mg alprazolamDRUG

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.

1.0 mg alprazolamDRUG

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.

placeboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

University of California, San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing

Analysis not completed.

Time frame: Same Day

Voxelwise Brain Imaging Data

Analysis of data not completed.

Time frame: Post-Rx Administration

Data from ClinicalTrials.gov

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