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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Murray B. Stein, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00703885
First received: June 20, 2008
Last updated: December 19, 2014
Last verified: December 2014
  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.


Condition Intervention Phase
Anxiety Disorders
Drug: 0.25 mg alprazolam
Drug: 1.0 mg alprazolam
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: PharmacofMRI of Anxiolytic Medications (Alprazolam)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing [ Time Frame: Same Day ] [ Designated as safety issue: No ]
    Analysis not completed.

  • Voxelwise Brain Imaging Data [ Time Frame: Post-Rx Administration ] [ Designated as safety issue: No ]
    Analysis of data not completed.


Enrollment: 16
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703885

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Murray B Stein, MD, MPH University of California, San Diego
  More Information

Publications:
Responsible Party: Murray B. Stein, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00703885     History of Changes
Other Study ID Numbers: UCSD IRB 060407 - A, R01MH075792
Study First Received: June 20, 2008
Results First Received: June 19, 2013
Last Updated: December 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
functional magnetic resonance imaging
fMRI
alprazolam
anxiety disorders

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Alprazolam
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 25, 2015