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NCT03826693 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design

Related Conditions & MeSH terms

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
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