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Inhalational Anesthetic

Nitrous Oxide for Fibromyalgia

Phase 2
Recruiting
Led By Peter Nagele, MD, MSc
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-report pain of at least 4 on the Numeric Pain Rating Scale (NPRS) at screening and baseline
Aged between 18 and 75 years
Must not have
Any other serious medical condition affecting heart, lung or any other organ system
Pain due to concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, or other chronic widespread pain condition(s) that may confound fibromyalgia pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 8-weeks from baseline

Summary

This trial is testing if inhaling nitrous oxide can help people with fibromyalgia by blocking certain brain signals that make pain feel worse. It focuses on patients who have not found relief from other treatments.

Who is the study for?
This trial is for adults aged 18-75 with fibromyalgia experiencing pain of at least a moderate level. Participants must have been on a stable treatment plan for fibromyalgia for four weeks prior to the study and meet specific diagnostic criteria. Pregnant individuals, those with significant psychiatric conditions or substance abuse history, or those using certain medications are excluded.
What is being tested?
The trial is testing whether inhaling nitrous oxide gas can help manage pain in fibromyalgia patients compared to a placebo. It aims to determine if this common anesthetic could be repurposed as a pain relief method for chronic conditions like fibromyalgia.
What are the potential side effects?
Nitrous oxide may cause side effects such as dizziness, nausea, headaches, and short-term confusion. Long-term use can lead to vitamin B12 deficiency and nerve damage but the study will monitor usage closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain level is at least 4 out of 10.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious conditions affecting my heart, lungs, or other organs.
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I have chronic pain from conditions like rheumatoid arthritis or lupus that might be confused with fibromyalgia pain.
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My medication doses, including for depression or muscle relaxation, have been stable.
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I am currently taking medication that affects brain signaling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 8-weeks from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 8-weeks from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Monitor changes in NPRS score
Secondary study objectives
Changes in FIQR
Changes in Global Impression of Change Scale
Computerize Adaptive Testing - Mental Health (CAT-MH) measurements
+1 more
Other study objectives
Adverse events

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment; Nitrous Oxide 50%Active Control1 Intervention
A single 60-minute session of inhaled 50% nitrous oxide.
Group II: Control; Oxygen-air mixturePlacebo Group1 Intervention
A single 60-minute session of inhaled Oxygen-air mixture

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,053 Previous Clinical Trials
759,024 Total Patients Enrolled
Peter Nagele, MD, MScPrincipal InvestigatorUniversity of Chicago, Department of Anesthesia and Critical Care
4 Previous Clinical Trials
743 Total Patients Enrolled
~7 spots leftby Jun 2025
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