Laughing gas for fibromyalgia? study pulled before it began
NCT ID NCT05357066
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if a one-hour session of inhaled nitrous oxide (laughing gas) could reduce pain in people with fibromyalgia. It was designed for adults aged 18-75 with moderate to severe pain. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
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Nov 2021
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Chicago
Chicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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