Nitrous Oxide as Treatment for Fibromyalgia
University of Chicago
50 participants
Nov 12, 2021
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to explore a potential role of nitrous oxide in treating pain associated with fibromyalgia.
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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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Interventions
Administration of inhaled 50% nitrous oxide in oxygen (FiO2 0.5) will be under the direct supervision of a licensed practitioner who is experienced in the use and administration of the study drug, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken (MD, or CRNA); with study patient monitoring of pulse oximetry, heart rate, respiratory, non-invasive blood pressure, and end-tidal carbon dioxide.
Administration of the placebo (oxygen-air mixture \[FiO2 ≈0.3\]), will be under the direct supervision of a licensed practitioner who is experienced in the use and administration of the study drug, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken (MD, or CRNA); with study patient monitoring of pulse oximetry, heart rate, respiratory, non-invasive blood pressure, and end-tidal carbon dioxide.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05357066