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Inhalational Anesthetic

Treatment; Nitrous Oxide 50% for Fibromyalgia

Phase 2

Recruiting

Led By Peter Nagele, MD, MSc

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-report pain of at least 4 on the Numeric Pain Rating Scale (NPRS) at screening and baseline

Aged between 18 and 75 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 8-weeks from baseline

Awards & highlights

Study Summary

This trial is testing whether laughing gas can help relieve pain for people with fibromyalgia.

Who is the study for?

This trial is for adults aged 18-75 with fibromyalgia experiencing pain of at least a moderate level. Participants must have been on a stable treatment plan for fibromyalgia for four weeks prior to the study and meet specific diagnostic criteria. Pregnant individuals, those with significant psychiatric conditions or substance abuse history, or those using certain medications are excluded.Check my eligibility

What is being tested?

The trial is testing whether inhaling nitrous oxide gas can help manage pain in fibromyalgia patients compared to a placebo. It aims to determine if this common anesthetic could be repurposed as a pain relief method for chronic conditions like fibromyalgia.See study design

What are the potential side effects?

Nitrous oxide may cause side effects such as dizziness, nausea, headaches, and short-term confusion. Long-term use can lead to vitamin B12 deficiency and nerve damage but the study will monitor usage closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My pain level is at least 4 out of 10.

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 8-weeks from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 8-weeks from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 8-weeks from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Monitor changes in NPRS score

Secondary outcome measures

Changes in FIQR

Changes in Global Impression of Change Scale

Computerize Adaptive Testing - Mental Health (CAT-MH) measurements

+1 more

Other outcome measures

Adverse events

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment; Nitrous Oxide 50%Active Control1 Intervention

A single 60-minute session of inhaled 50% nitrous oxide.

Group II: Control; Oxygen-air mixturePlacebo Group1 Intervention

A single 60-minute session of inhaled Oxygen-air mixture

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,010 Previous Clinical Trials

733,881 Total Patients Enrolled

Peter Nagele, MD, MScPrincipal InvestigatorUniversity of Chicago, Department of Anesthesia and Critical Care

4 Previous Clinical Trials

743 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment of participants for this clinical trial?

"This clinical trial, which originated on November 12th 2021 according to records from clinicaltrials.gov, is presently in search of participants. The last update was made on April 26th 2022."

Answered by AI

Am I qualified to participate in this medical experiment?

"This clinical trial is searching for 50 individuals aged 18 to 75, who are living with fibromyalgia and meet the following criteria: ability to understand the research protocol, provision of written consent, adherence to study restrictions, return for required evaluations, 2016 American College of Rheumatology-defined fibromyalgia (2016-ACR), self-reported pain score of 4 or higher on Numeric Pain Rating Scale at screening & baseline visits, stable medication regimen established four weeks before dosing, if applicable psychotherapy must have been maintained at constant frequency."

Answered by AI

How many participants can be accepted into this experiment?

"Affirmative. According to clinicaltrials.gov, this research is actively seeking participants and was initially posted on November 12th 2021. The researchers need 50 volunteers across 1 medical facility for the study and have recently updated it as of April 26th 2022."

Answered by AI

Is Nitrous Oxide 50% a risk-free form of treatment for individuals?

"A score of 2 was given to Nitrous Oxide 50% due to Phase 2 data indicating safety, but no research yet verifying its efficacy."

Answered by AI

Is the elderly population being targeted for enrollment in this clinical experiment?

"Eligibility for this medical trial necessitates that patients are aged 18 to 75. For those below the age of majority, there are 15 studies available and 216 for seniors over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?

Maryland

Illinois

Nebraska

Other

How old are they?

18 - 65

What site did they apply to?

University of Chicago

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I was diagnosed with fibro over twenty years ago and the opioids I use only help so much. I would love to have the chance to try anything that would help me return to who I was before I had this disease.

PatientReceived no prior treatments

I tried all the approved and off label fibro treatments after I was diagnosed with Fibromyalgia in 2010. My pain scale then was 7-8. I was pretty much bed ridden. None worked although Savellla helped some giving about 2 pain scale relief for 6 months then it went higher than before and coming off was no picnic. I found that high dose B-1 helps tremendously with the CFS fatigue. In 2019 I was diagnosed with Lyme and also Polymyalgia Rheumatica. 4 years on low dose prednisone. My pain is at 5-6 all the time. We got my dose down to 7.5 a day. Any less skyrockets my pain levels to screaming levels again. I’ve learned through all these years that screaming pain doesn’t mean I am screaming in pain. It means the pain is so bad there is a constant scream in my head attached to the high pain levels. Me screaming is at 9-10 pain levels. But 7-8 is that internal screaming sound in my head attached to the pain.

PatientReceived 1 prior treatment

Recent research and studies

Clinical TherapeuticsJournal

Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple-dose Clinical Trial

Clauw, Daniel J., Philip Mease, Robert H. Palmer, R. Michael Gendreau, and Yong Wang. 2008. “Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple-dose Clinical Trial”. Clinical Therapeutics. Elsevier BV. doi:10.1016/j.clinthera.2008.11.009.

Mayo Clinic ProceedingsJournal

A Framework for Fibromyalgia Management for Primary Care Providers

Arnold, Lesley M., Daniel J. Clauw, L. Jean Dunegan, and Dennis C. Turk. 2012. “A Framework for Fibromyalgia Management for Primary Care Providers”. Mayo Clinic Proceedings. Elsevier BV. doi:10.1016/j.mayocp.2012.02.010.

Mayo Clinic ProceedingsJournal

The Science of Fibromyalgia

Clauw, Daniel J., Lesley M. Arnold, and Bill H. McCarberg. 2011. “The Science of Fibromyalgia”. Mayo Clinic Proceedings. Elsevier BV. doi:10.4065/mcp.2011.0206.

Nature MedicineJournal