Nitrous Oxide as Treatment for Fibromyalgia

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia, Central Neuropathic Pain

In brief

The purpose of this study is to explore a potential role of nitrous oxide in treating pain associated with fibromyalgia.

Key facts

Study ID

NCT05357066

Run by

University of Chicago

People needed

0

Starts

2021-11-12

Expected to finish

2026-02-27

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 2016 American College of Rheumatology Revised criteria for fibromyalgia (2016-ACR)
• Subjects 18 -75 years of age.
• Self-reported pain of at least 4 on the Numeric Pain Rating Scale (NPRS) at screening and baseline.
• Subject receives and agrees to remain on their stable fibromyalgia treatment plan established at least 4 weeks prior to dosing. Stable means no change in dose or any pain medication.
• Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
• If currently on psychotherapy, it must have been maintained at the same frequency for 4 weeks prior to treatment.

You may not qualify if…

• Unstable doses of allowed antidepressants or muscle relaxants or dosages for any other medical condition.
• 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.
• Psychiatric or cognitive disorder (e.g., current schizophrenia, severe depression, suicidal ideation, dementia, etc.) that the investigator or sponsor considers significant for this study.
• Clinically significant alcohol or other substance abuse within the last 2 years, in the opinion of the investigator.
• Current or recent history of medically inappropriate or illegal use of drugs of abuse including benzodiazepines, opiates, cocaine, cannabinoids, and amphetamines.
• Current treatment with N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, amantadine, dextromethorphan, memantine, methadone, or dextropropoxyphene.
• Subjects who are pregnant, breast feeding, or planning to become pregnant during the course of the study and for 28 days after the final administration of investigational product.
• Any other serious medical condition affecting heart, lung or any other organ system.
• Any impairment, activity or situation that in the judgment of the investigator would prevent satisfactory completion of the study protocol.

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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