RECRUITING

Nitrous Oxide as Treatment for Fibromyalgia

Conditions

Fibromyalgia Central Neuropathic Pain Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Nitrous Oxide as Treatment for Fibromyalgia

Quick Facts

Study Start:2021-11-12

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05357066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Frank Brown Jr

CONTACT

773-834-5778

ftbrownjr@uchicagomedicine.org

Principal Investigator

Peter Nagele, MD, MSc

PRINCIPAL_INVESTIGATOR

University of Chicago, Department of Anesthesia and Critical Care

Study Locations (Sites)

University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Peter Nagele, MD, MSc, PRINCIPAL_INVESTIGATOR, University of Chicago, Department of Anesthesia and Critical Care

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-12

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-11-12

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

Fibromyalgia
Pain

Additional Relevant MeSH Terms

Fibromyalgia
Central Neuropathic Pain