search
Back to results

Efficacy of Nitrous Oxide in OCD: Pilot Study

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitrous Oxide
Nitrogen
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, nitrous oxide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Nitrous Oxide

Control: Nitrogen

Arm Description

OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.

OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2019
Last Updated
September 27, 2023
Sponsor
Stanford University
Collaborators
Brain & Behavior Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03826693
Brief Title
Efficacy of Nitrous Oxide in OCD: Pilot Study
Official Title
Efficacy of Nitrous Oxide in OCD: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Brain & Behavior Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD, nitrous oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
placebo-controlled 2:1 randomized clinical trial.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Nitrous Oxide
Arm Type
Experimental
Arm Description
OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.
Arm Title
Control: Nitrogen
Arm Type
Placebo Comparator
Arm Description
OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Intervention Description
OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Nitrogen
Intervention Description
OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.
Primary Outcome Measure Information:
Title
Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavithra Mukunda, MS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sindu Menon, MBBS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J van Roessel, MD, PhD
Organizational Affiliation
Stanford Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavithra Makunda, MS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name & Degree
Sindu Menon, MBBS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name & Degree
Peter van Roessel, MD, PhD

12. IPD Sharing Statement

Links:
URL
https://med.stanford.edu/profiles/peter-van-roessel
Description
Stanford Medicine Faculty Page
URL
https://rodriguezlab.stanford.edu
Description
Rodriguez Lab Website

Learn more about this trial

Efficacy of Nitrous Oxide in OCD: Pilot Study

We'll reach out to this number within 24 hrs