Remimazolam NeuroImaging

NCT07290205 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: STUDY25110017R35GM146822
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm functional MRI study that will determine the effects of remimazolam on cognition and brain activity and connectivity at rest, during noxious stimulation, and during a memory encoding task

Conditions

Anesthesia; Pain; Remimazolam

Keywords

Remimazolam; functional MRI; electric nerve stimulation; sedation; functional connectivity; memory; pain

Outcome Measures

Primary Outcomes (2)

• Explicit memory performance

  Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.

  Day/Visit 2: 12-36 hours after day 1 session

• subjective pain ratings

  Numerical ratings of pain intensity and unpleasantness will be obtained after each experimental period involving repeated noxious stimulation. Values will be on a 0-10 scale, with 0 representing none and 10 representing the worst possible rating.

  Day/Visit 1: immediately after no-drug condition MRI scan and immediately after remimazolam condition MRI scan

Secondary Outcomes (3)

• functional magnetic resonance imaging activation of memory encoding task

  Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan

• functional magnetic resonance imaging activation of the response to noxious stimulation

  Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan

• Functional connectivity

  Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan

Study Arms (1)

Remimazolam+Pain

EXPERIMENTAL

Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.

Drug: Remimazolam; Device: Peripheral Nerve Stimulation

Interventions

Remimazolam DRUG

Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.

Remimazolam+Pain

Peripheral Nerve Stimulation DEVICE

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.

Remimazolam+Pain

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 18-59 years of age, who:

You may not qualify if:

• have a valid email address and valid phone number throughout the study
• 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

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): collaborator
• Keith M Vogt: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

remimazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith M Vogt, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith M Vogt, MD, PhD

CONTACT

4126473147; kev18@pitt.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 18, 2025
• Study Start: March 27, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 2, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After analysis is complete and results have been published, all the above data will be shared in de-identified format, linked together by an assigned subject number.
• Access Criteria: Data will be shared via a publicly-accessible online platform that allows user download at no cost.

Locations

US (1)