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Nitrous Oxide for Pain (NONI Trial)
Phase < 1
Waitlist Available
Research Sponsored by Keith M Vogt
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
Must not have
Any severe or poorly-controlled medical problem (hypertension, diabetes)
Sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2: 24 hours post-learning experiment
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate how acute pain affects long-term memory and physical responses when low dose nitrous oxide is present. It will use brain imaging to see how the brain is involved in these processes. The
Who is the study for?
This trial is for individuals experiencing amnesia or pain who can undergo two visits with no long-term follow-up. Specific eligibility details are not provided, but typically participants must be in good health and meet certain age and condition severity criteria.
What is being tested?
The study tests the effects of low dose nitrous oxide on memory and body responses to acute pain using brain imaging (fMRI). It also explores how peripheral nerve stimulation impacts these outcomes over two separate visits.
What are the potential side effects?
While specific side effects are not listed, nitrous oxide may cause nausea, dizziness, fatigue, or headache. Peripheral nerve stimulation might lead to discomfort at the stimulation site.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My medical conditions like high blood pressure or diabetes are well-managed.
Select...
I have sleep apnea.
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I frequently take pain medication or have chronic pain.
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I have a history of MTHFR mutation.
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I have a serious heart condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2: 24 hours post-learning experiment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2: 24 hours post-learning experiment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain activation to painful stimulation difference: Drug-free condition minus nitrous oxide condition
Resting-state functional connectivity difference: Drug-free minus nitrous oxide condition
Secondary study objectives
Explicit memory performance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nitrous Oxide + PainExperimental Treatment2 Interventions
Single-arm study. All subjects receive nitrous oxide and painful electric nerve stimulation, as described in the interventions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral Nerve Stimulation
2016
Completed Phase 1
~1520
Nitrous oxide
2007
Completed Phase 4
~990
Find a Location
Who is running the clinical trial?
Keith M VogtLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
297 Previous Clinical Trials
248,945 Total Patients Enrolled