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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

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 ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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
2,579 Previous Clinical Trials
3,316,913 Total Patients Enrolled
Mclean HospitalLead Sponsor
216 Previous Clinical Trials
21,861 Total Patients Enrolled
Stephanie C Licata, PhDPrincipal InvestigatorMclean Hospital
1 Previous Clinical Trials
14 Total Patients Enrolled
~1 spots leftby Nov 2025