Efficacy of Nitrous Oxide in OCD: Pilot Study

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Efficacy of Nitrous Oxide in OCD: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03826693
• Other study ID #: 48077
• Status: Recruiting
• Phase: Phase 2
• Start date: April 17, 2021
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: Pavithra Mukunda, MS
• Phone: 650-723-4095
• Email: ocdresearch[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates whether the commonly used and well-tolerated inhaled anesthetic nitrous oxide can rapidly improve symptoms of OCD.

Description:

Obsessive-compulsive disorder (OCD) is a chronic and disabling disorder characterized by recurrent intrusive thoughts and associated compulsive behaviors that is estimated to affect more than 3 million individuals in the US each year.

This study seeks to explore whether a single inhalation of nitrous oxide gas may bring about rapid symptom relief in OCD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65

• Primary diagnosis of OCD

• Sufficient severity of OCD symptoms

• Ability to tolerate a treatment-free period

• Capacity to provide informed consent

Exclusion Criteria:

• Psychiatric or medical conditions that make participation unsafe

• Pregnant or nursing females

• Concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Drug:
• Nitrous Oxide
OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.
• Nitrogen
OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)	Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.	1 week

External Links

•   Rodriguez Lab Website
•   Stanford Medicine Faculty Page