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

December 19, 2014 updated by: Murray B. Stein, University of California, San Diego

PharmacofMRI of Anxiolytic Medications (Alprazolam)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1

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

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.

Other Names:
  • Xanax
Active Comparator: 2

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

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.

Other Names:
  • Xanax
Placebo Comparator: Placebo

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

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 24, 2008

Study Record Updates

Last Update Posted (Estimate)

December 22, 2014

Last Update Submitted That Met QC Criteria

December 19, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSD IRB 060407 - A
  • R01MH075792 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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