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RECRUITING

NCT05357066

PHASE2

Nitrous Oxide as Treatment for Fibromyalgia

Sponsor: University of Chicago

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-11-12

Completion Date

2027-12-01

Last Updated

2026-01-12

Healthy Volunteers

Yes

Conditions

Fibromyalgia Central Neuropathic Pain

Interventions

DRUG

Nitrous oxide gas for inhalation

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.

DRUG

Placebo

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.

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.

Locations (1)

University of Chicago

Chicago, Illinois, United States