Efficacy of Nitrous Oxide in OCD: Pilot Study

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03826693

Collaborator

Brain & Behavior Research Foundation (Other)

Enrollment

Location

Arms

17.5

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Drug: Nitrous Oxide Drug: Nitrogen	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

placebo-controlled 2:1 randomized clinical trial.placebo-controlled 2:1 randomized clinical trial.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Nitrous Oxide in OCD: Pilot Study

Actual Study Start Date :

Apr 17, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Nitrous Oxide OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.	Drug: Nitrous Oxide OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.
Placebo Comparator: Control: Nitrogen OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.	Drug: Nitrogen OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.

Arm

Intervention/Treatment

Experimental: Experimental: Nitrous Oxide

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

Drug: Nitrous Oxide

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

Placebo Comparator: Control: Nitrogen

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

Drug: Nitrogen

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94304

Sponsors and Collaborators

Stanford University
Brain & Behavior Research Foundation

Investigators

Principal Investigator: Peter J van Roessel, MD, PhD, Stanford Univeristy

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Peter J van Roessel, MD PhD, Clinical Associate Professor, Department of Psychiatry and Behavioral Sciences, Stanford University

ClinicalTrials.gov Identifier:

NCT03826693

Other Study ID Numbers:

48077

First Posted:

Feb 1, 2019

Last Update Posted:

May 10, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Peter J van Roessel, MD PhD, Clinical Associate Professor, Department of Psychiatry and Behavioral Sciences, Stanford University

OCD

nitrous oxide

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder

Nitrous Oxide

Study Results

No Results Posted as of May 10, 2022