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
2025-01-13
2026-06-01
Brief Summary
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Detailed Description
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The investigators propose to complete the following 3 Aims, at a targeted sedative dose of nitrous oxide, compared to no-drug baseline, using functional MRI:
Aim 1: Determine how the brain response to acute pain stimulation is modulated by nitrous oxide. It is anticipated that nitrous oxide will correlate to decreased activation in both somatosensory (thalamus, insula, primary somatosensory/motor) and affective (anterior cingulate) components of the pain processing brain areas.
Aim 2: Determine how memory encoding is modulated by nitrous oxide, in the context of periodic painful stimulation. It is anticipated that nitrous oxide will correlate to decreased activation in both the explicit memory (hippocampus, parahippocampus) and associative learning (amygdala, anterior cingulate) brain systems.
Aim 3: Determine the neural effects of inhalational nitrous oxide on brain connectivity both at rest and during the combined pain and memory task performance. It is anticipated that nitrous oxide will cause widespread dose-dependent decreases in long-range functional connectivity between brain areas known to be involved in pain processing and to the default mode network, and that this connectivity will differ between the resting (task-free) and periodic pain states.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Nitrous Oxide + Pain
Single-arm study. All subjects receive nitrous oxide and painful electric nerve stimulation, as described in the interventions.
Nitrous oxide
After a no-drug control period, subjects will inhale nitrous oxide, administered via a breathing circuit and face mask, until a steady-state target end-tidal expired concentration is reached. During the drug condition, subjects will receive low-dose nitrous oxide (% corresponding to Minimum Alveolar Concentration).
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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Nitrous oxide
After a no-drug control period, subjects will inhale nitrous oxide, administered via a breathing circuit and face mask, until a steady-state target end-tidal expired concentration is reached. During the drug condition, subjects will receive low-dose nitrous oxide (% corresponding to Minimum Alveolar Concentration).
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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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)
* any severe or poorly-controlled medical problem (hypertension, diabetes)
* neurologic or psychiatric disease, including anxiety, and depression
* severe cardiac disease
* history of methylenetetrahydrofolate reductase (MTHFR) deficiency or variant mutation, as assessed by personal report
* recent ear or eye surgery
* being claustrophobic
* have metal implants or non-removable metal piercings
* having a history of adverse reaction to anesthetics
* 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
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY24100059
Identifier Type: -
Identifier Source: org_study_id