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Imaging the Effects of Zolpidem and Alprazolam in Healthy Volunteers at 3T

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Stephanie C. Licata, Ph.D., Mclean Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747590
First Posted: December 11, 2012
Last Update Posted: December 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Stephanie C. Licata, Ph.D., Mclean Hospital
  Purpose
The primary goal of this double-blind, placebo-controlled, within-subjects functional neuroimaging study is to examine the extent to which the hypnotic zolpidem decreases brain activity in regions of the brain known to process emotional information. Although zolpidem is an effective sleep-aid, its ability to engender anti-anxiety effects is equivocal, yet promising. Zolpidem's activity during tasks that engage anxiety-related processes in the brain will be compared to that of the known anxiolytic drug alprazolam, a positive comparator caffeine, and placebo. A secondary goal of this study is to compare the subjective drug effects, or how individuals feel, following the interventions. These measures will be used to determine the existence of brain-behavior relationships, thus demonstrating that imaging is an important tool for informing us about how drugs produce their effects in the brain.

Condition Intervention Phase
Psychotropic Drugs Effects Drug: Zolpidem Drug: Alprazolam Drug: Caffeine Other: Placebo Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Imaging the Effects of Zolpidem and Alprazolam in Healthy Volunteers at 3T

Resource links provided by NLM:


Further study details as provided by Stephanie C. Licata, Ph.D., Mclean Hospital:

Primary Outcome Measures:
  • Change in blood oxygen level-dependent (BOLD) signal as measured with fMRI [ Time Frame: 45 min after drug administration ]

Secondary Outcome Measures:
  • Change in subjective drug effects as measured by self-report questionnaires [ Time Frame: Over the course of 6 hours ]

Estimated Enrollment: 12
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zolpidem, Alprazolam, Caffeine, and Placebo
The 4 medications are given in a counterbalanced design.
Drug: Zolpidem
Other Name: Ambien
Drug: Alprazolam
Other Name: Xanax
Drug: Caffeine
Other Name: No Doz
Other: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Participants will be right-handed male and female volunteers between the ages of 21-40
  • Participants will consume between 100 and 300 mg caffeine on a daily basis
  • Participants cannot meet DSM-IV criteria for lifetime and/or current mood, anxiety, psychotic, and alcohol/drug use disorders as identified by the SCID
  • Participants must report ≤ 10 lifetime experiences with substances other than nicotine and alcohol
  • Participants cannot be taking any prescription medication (except certain short-term anti fungal agents and some topical creams for dermal conditions)
  • Participants cannot be taking any psychotropic medications
  • Non-smoking participants are preferred, but will admit those who smoke less than 5 cigarettes per day
  • Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.
  • Participants cannot have any conditions that are contraindicated for MRI
  • Participants cannot have a family history of alcoholism
  • Participants cannot have any abnormal blood chemistries/urinalysis results, current or past cardiac problems, or any other medical condition that may affect drug disposition (e.g., Hepatitis C)
  • Participants cannot be taking oral contraceptives (Kalow and Tank, 1991; O'Connell, 1995) or be pregnant
  • Participants must be able to read screening materials including consent form and give informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747590


Contacts
Contact: Nina A Conn, BA 617-855-2902 nconn@mclean.harvard.edu
Contact: Stephanie C Licata, PhD 617-855-2738 slicata@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Nina A Conn, BA    617-855-2902    nconn@mclean.harvard.edu   
Principal Investigator: Stephanie C Licata, PhD         
Sponsors and Collaborators
Mclean Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Stephanie C Licata, PhD Mclean Hospital
  More Information

Responsible Party: Stephanie C. Licata, Ph.D., Assistant Professor, Department of Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01747590     History of Changes
Other Study ID Numbers: 2011P000058
K01DA023659 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2012
First Posted: December 11, 2012
Last Update Posted: December 11, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Caffeine
Zolpidem
Alprazolam
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Hypnotics and Sedatives
Central Nervous System Depressants
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators


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