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

Primary Purpose

Anxiety Disorders

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

0.25 mg alprazolam

1.0 mg alprazolam

placebo

About this trial

This is an interventional diagnostic trial for Anxiety Disorders focused on measuring functional magnetic resonance imaging, fMRI, alprazolam, anxiety disorders

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing

Analysis not completed.

Voxelwise Brain Imaging Data

Analysis of data not completed.

Secondary Outcome Measures

Full Information

NCT ID

NCT00703885

First Posted

June 20, 2008

Last Updated

December 19, 2014

Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00703885

Brief Title

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

Official Title

PharmacofMRI of Anxiolytic Medications (Alprazolam)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders

Keywords

functional magnetic resonance imaging, fMRI, alprazolam, anxiety disorders

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

0.25 mg alprazolam

Other Intervention Name(s)

Xanax

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

1.0 mg alprazolam

Other Intervention Name(s)

Xanax

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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 Outcome Measure Information:

Title

Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing

Description

Analysis not completed.

Time Frame

Same Day

Title

Voxelwise Brain Imaging Data

Description

Analysis of data not completed.

Time Frame

Post-Rx Administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murray B Stein, MD, MPH

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19545475

Citation

Simmons AN, Arce E, Lovero KL, Stein MB, Paulus MP. Subchronic SSRI administration reduces insula response during affective anticipation in healthy volunteers. Int J Neuropsychopharmacol. 2009 Sep;12(8):1009-20. doi: 10.1017/S1461145709990149. Epub 2009 Jun 23.

Results Reference

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PubMed Identifier

21430645

Citation

Aupperle RL, Ravindran L, Tankersley D, Flagan T, Stein NR, Simmons AN, Stein MB, Paulus MP. Pregabalin influences insula and amygdala activation during anticipation of emotional images. Neuropsychopharmacology. 2011 Jun;36(7):1466-77. doi: 10.1038/npp.2011.32. Epub 2011 Mar 23.

Results Reference

background

PubMed Identifier

22470326

Citation

Aupperle RL, Tankersley D, Ravindran LN, Flagan T, Stein NR, Stein MB, Paulus MP. Pregabalin effects on neural response to emotional faces. Front Hum Neurosci. 2012 Mar 27;6:42. doi: 10.3389/fnhum.2012.00042. eCollection 2012.

Results Reference

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

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