Nitrous Oxide as Treatment for Fibromyalgia

Launched by UNIVERSITY OF CHICAGO · Apr 26, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at whether nitrous oxide, a gas often used for pain relief during dental procedures, can help reduce the pain associated with fibromyalgia. Fibromyalgia is a condition that causes widespread pain, and this study aims to see if nitrous oxide can provide some relief for patients experiencing this type of pain. The trial is currently recruiting participants aged 18 to 75 who have been diagnosed with fibromyalgia and have a certain level of ongoing pain. Importantly, participants must also be stable on their current fibromyalgia treatment for at least four weeks before joining the study.

If you decide to participate, you can expect to receive nitrous oxide treatment in a controlled environment while continuing your regular pain management plan. The study team will monitor your progress and pain levels throughout the trial. However, there are some exclusions, such as having other serious health conditions or unstable medication changes, which could affect your eligibility. Overall, this trial could be a chance to explore a new treatment option for fibromyalgia pain while contributing to important medical research.

Gender

ALL

Eligibility criteria

• 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.