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

NCT ID: NCT00703885

Last Updated: 2014-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Anxiety Disorders

Keywords

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functional magnetic resonance imaging fMRI alprazolam anxiety disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

0.25 mg alprazolam

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

1.0 mg alprazolam

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Xanax Xanax

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Murray B. Stein

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murray B Stein, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego

La Jolla, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19545475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21430645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22470326 (View on PubMed)

Other Identifiers

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R01MH075792

Identifier Type: NIH

Identifier Source: secondary_id

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UCSD IRB 060407 - A

Identifier Type: -

Identifier Source: org_study_id