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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Mclean Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephanie C. Licata, Ph.D., Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01747590
First received: December 7, 2012
Last updated: December 10, 2012
Last verified: December 2012
  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
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 Mclean Hospital:

Primary Outcome Measures:
  • Change in blood oxygen level-dependent (BOLD) signal as measured with fMRI [ Time Frame: 45 min after drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in subjective drug effects as measured by self-report questionnaires [ Time Frame: Over the course of 6 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
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
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: 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
Investigators
Principal Investigator: Stephanie C Licata, PhD Mclean Hospital
  More Information

No publications provided

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
Study First Received: December 7, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 11, 2014