Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
60 participants
INTERVENTIONAL
2026-03-01
2027-12-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Remimazolam+Pain
Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.
Remimazolam
Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.
Peripheral Nerve Stimulation
Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants.
Interventions
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Remimazolam
Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.
Peripheral Nerve Stimulation
Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* free from any non-MRI compatible implants
* are pregnant or attempting to conceive
* body mass index (BMI) \> 35
* significant memory impairment or hearing loss
* sleep apnea
* chronic pain or frequently taking pain medication (including tramadol)
* chronic medical conditions requiring treatment (hypertension, diabetes, high cholesterol)
* neurologic disease, including seizures and tremor
* psychiatric diagnoses, including anxiety, depression, panic, or PTSD
* a history of any of these medical conditions: abnormal heartbeats (cardiac conduction abnormality or arrhythmia), liver or kidney disease, or significant lung disease
* severe claustrophobia or MRI intolerance
* have metal implants or non-removable metal piercings
* having a history of adverse reaction to midazolam (Versed), lorazepam (Ativan) or another benzodiazepine class medication
* are allergic to dextran
* daily alcohol or heavy alcohol use; history of alcohol abuse
* current daily smoker
* regular or recent marijuana use (including prescribed/medical marijuana)
* illicit drug use, i.e., street drugs
* regularly taking: antiepileptics, antidepressants, anti-psychotics, antihistamines, anti-anxiety medication, stimulants, or sleep-aids
18 Years
59 Years
ALL
Yes
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
Keith M Vogt
OTHER
Responsible Party
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Keith M Vogt
Associate Professor
Principal Investigators
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Keith M Vogt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Keith M Vogt, MD, PhD
Role: primary
Other Identifiers
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STUDY25110017
Identifier Type: -
Identifier Source: org_study_id