Treatment; Nitrous Oxide 50% for Fibromyalgia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fibromyalgia+3 More
Nitrous oxide gas for inhalation - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Fibromyalgia
  • Central Neuropathic Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Over 8-weeks from baseline

Over 8-weeks (length of study participation)
Adverse events
Over 8-weeks from baseline
Computerize Adaptive Testing - Mental Health (CAT-MH) measurements
Over 8-weeks from baseline (length of study participation)
Changes in FIQR
Changes in Global Impression of Change Scale
Hospital Anxiety and Depression Scale
Monitor changes in NPRS score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Treatment; Nitrous Oxide 50%
1 of 2
Control; Oxygen-air mixture
1 of 2
Active Control
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment; Nitrous Oxide 50% · Has Placebo Group · Phase 2

Treatment; Nitrous Oxide 50%
Drug
ActiveComparator Group · 1 Intervention: Nitrous oxide gas for inhalation · Intervention Types: Drug
Control; Oxygen-air mixture
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 8-weeks from baseline

Who is running the clinical trial?

University of ChicagoLead Sponsor
917 Previous Clinical Trials
742,297 Total Patients Enrolled
Peter Nagele, MD, MScPrincipal InvestigatorUniversity of Chicago, Department of Anesthesia and Critical Care
2 Previous Clinical Trials
193 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
The 2016 American College of Rheumatology Revised criteria for fibromyalgia are used to classify patients with fibromyalgia.
You are currently on psychotherapy

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Oregon50.0%
Washington50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Chicago100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
References