Efficacy of Nitrous Oxide in OCD: Pilot Study

Phase 2

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Nitrogen; Drug: Nitrous Oxide

• Registration Number: NCT03826693
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2021-04-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-09
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: Nitrogen	Nitrogen	OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.
Experimental: Nitrous Oxide	Nitrous Oxide	OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.

Primary Outcome Measures

Name	Time	Method
Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)	1 week	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States