Network-Level Effects of Nitrous Oxide in the Human Brain

NCT ID: NCT03435055

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-21
• Study Completion Date: 2019-10-11

Brief Summary

The purpose of this study is to understand how a commonly used drug, nitrous oxide, acts on the brain to reduce pain. Nitrous oxide is commonly used in anesthesiology but there is limited knowledge on how this drug affects functional networks in the brain.

Detailed Description

The objective of this study is to identify the network transformations that account for the analgesic effects of nitrous oxide. Our hypothesis is that analgesic doses of nitrous oxide increase network efficiency and disrupt normal pain processingOur approach is to administer subanesthetic nitrous oxide during the acquisition of fMRI (functional magnetic resonance imaging) and EEG (electroencephalogram).

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Nitrous Oxide - inhaled

Each volunteer will participate in one scanning visit in which simultaneous functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanalgesic levels (35% inhaled concentration) over 40 minutes.

Group Type: EXPERIMENTAL

Nitrous Oxide Gas for Inhalation

Intervention Type: DRUG

Each volunteer will participate in one scanning visit in which simultaneous functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanesthetic levels (35% inhaled concentration) over 40 minutes.

Interventions

Nitrous Oxide Gas for Inhalation

Each volunteer will participate in one scanning visit in which simultaneous functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanesthetic levels (35% inhaled concentration) over 40 minutes.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Body mass index <30

2. Must be right-handed

3. Must be capable of giving written informed consent

Exclusion Criteria

1. History of obstructive sleep apnea;

2. History of a difficult airway with a previous anesthetic

3. Gastroesophageal reflux;

4. Hypertension or other cardiovascular abnormalities;

5. Pulmonary hypertension;

6. History of recreational drug use;

7. History of chronic alcohol abuse

8. Having any chronic medical illness involving pain;

9. History of major depression;

10. History of psychosis or bipolar disorder;

11. History of methylenetetrahydrofolate reductase deficiency;

12. History of a known hypersensitivity to ketamine, midazolam, Zofran, labetalol or glycopyrrolate

13. History of seizures or other neurologic disorders;

14. Pregnant or nursing mothers;

15. Tattoos on the head or neck region - all other tattoos are subject to determination by investigators;

16. Contraindications to neuroimaging methods;

17. Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Richard Harris

Associate Professor of Anesthesiology and Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Anesthesiology and Associate Professor of Internal Medicine

Locations

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Dai R, Larkin TE, Huang Z, Tarnal V, Picton P, Vlisides PE, Janke E, McKinney A, Hudetz AG, Harris RE, Mashour GA. Classical and non-classical psychedelic drugs induce common network changes in human cortex. Neuroimage. 2023 Jun;273:120097. doi: 10.1016/j.neuroimage.2023.120097. Epub 2023 Apr 7.

Reference Type: DERIVED

PMID: 37031827 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00096321

Identifier Type: -

Identifier Source: org_study_id