Status:
RECRUITING
Nitrous Oxide as Treatment for Fibromyalgia
Lead Sponsor:
University of Chicago
Conditions:
Fibromyalgia
Central Neuropathic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore a potential role of nitrous oxide in treating pain associated with fibromyalgia.
Detailed Description
Investigators are conducting this trial to determine the efficacy of nitrous oxide on fibromyalgia, a chronic, debilitating, disorder typified by widespread musculoskeletal pain, accompanied by sympto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05357066
Start Date
November 12 2021
End Date
December 1 2026
Last Update
June 6 2025
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637