Official Title: “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 Type: Interventional

Study Design: Diagnostic, Randomized, Single Blind (Subject), Crossover Assignment

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• Drug: alprazolam
  • alprazolam 0.25 mg PO (liquid) to be administered 1 hour prior to fMRI scan
• Drug: alprazolam
  • Alprazolam 1 mg PO (liquid) will be administered 1 hour prior to fMRI scan
• Drug: placebo
  • Placebo (liquid) to be administered 1 hour prior to fMRI scan

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Alprazolam 0.25 mg PO (liquid) will be administered 1 hour prior to fMRI scan
• Active Comparator: 2
  • Alprazolam 1 mg PO (liquid) will be administered 1 hour prior to fMRI scan
• Placebo Comparator: Placebo

Primary Measures

• To evaluate the effect of an anxiolytic drug versus placebo on brain activity at rest and during emotional stimuli using fMRI.
  • Time Frame: 3 weeks
    Safety Issue?: No

Secondary Measures

• To evaluate the effects of an anxiolytic drug versus placebo on eye blink startle response at rest and during emotional stimuli (anxiety potentiated startle, APS) as well as on clinical scales.
  • Time Frame: 3 weeks
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of California, San Diego

Overall Clinical Trial Officials and Contacts

Murray B Stein, MD, MPH Principal Investigator University of California, San Diego  

Overall Contact: Lakshmi Ravindran, MD 858-534-7352 lravindran@ucsd.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00703885

Study ID Number: UCSD IRB 060407 - A

ClinicalTrials.gov Identifier: NCT00703885

Health Authority: United States: Institutional Review Board