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Completed

NCT Number: NCT00703885

PharmacofMRI (Functional Magnetic Resonance Imaging) 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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

0.25 mg alprazolam

Drug

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

1.0 mg alprazolam

Drug

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

Drug

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.

Primary outcomes

  1. Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing

    Time frame: Same Day

    Analysis not completed.

  2. Voxelwise Brain Imaging Data

    Time frame: Post-Rx Administration

    Analysis of data not completed.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

PharmacofMRI of Anxiolytic Medications (Alprazolam)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 24, 2008
Registry last updated
Dec 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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