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

NCT01747590 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-12-11

No results posted yet for this study

Summary

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.

Conditions

  • Psychotropic Drugs Effects

Interventions

DRUG

Zolpidem

DRUG

Alprazolam

DRUG

Caffeine

OTHER

Placebo

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Stephanie C Licata, PhD · Mclean Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01747590 on ClinicalTrials.gov