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Caffeine for Psychotropic Drug Effects

Phase < 1
Waitlist Available
Led By Stephanie C Licata, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 min after drug administration
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 min after drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 min after drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in blood oxygen level-dependent (BOLD) signal as measured with fMRI
Secondary outcome measures
Change in subjective drug effects as measured by self-report questionnaires

Trial Design

1Treatment groups
Experimental Treatment
Group I: Zolpidem, Alprazolam, Caffeine, and PlaceboExperimental Treatment4 Interventions
The 4 medications are given in a counterbalanced design.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caffeine
FDA approved
Alprazolam
FDA approved
Zolpidem
FDA approved

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,581 Total Patients Enrolled
Mclean HospitalLead Sponsor
212 Previous Clinical Trials
21,582 Total Patients Enrolled
Stephanie C Licata, PhDPrincipal InvestigatorMclean Hospital
1 Previous Clinical Trials
14 Total Patients Enrolled

Frequently Asked Questions

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~1 spots leftby Apr 2025