Back to resultsExploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD) (tN2O)
Primary Purpose
Post Traumatic Stress Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitrous Oxide
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD
Eligibility Criteria
Inclusion Criteria:
- age 18-80
- Veterans of the United States Uniformed Services
- primary diagnosis of PTSD
- sufficient severity of PTSD symptoms
- fluency in English
- capacity to provide informed consent
Exclusion Criteria:
- psychiatric or medical conditions that make participation unsafe
- pregnant or nursing females
- allergy to nitrous oxide
Sites / Locations
- Veterans Affairs Palo Alto
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nitrous Oxide
Arm Description
PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour
Outcomes
Primary Outcome Measures
Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Patients given CAPS-5 (Clinician Administered PTSD Scale for DSM-5), a 30-item structured interview that can be used to assess PTSD symptoms over the past week. For the CAPS-5 the minimum units are 0 and maximum units on the total scale are 80. The higher the number on the CAPS-5, the more severe the symptoms. Response was defined as at least a 12 point reduction on the CAPS-5
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03375294
Brief Title
Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
Acronym
tN2O
Official Title
Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
April 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
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
Yes
5. Study Description
Brief Summary
The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)
Detailed Description
Post traumatic stress disorder (PTSD) is a disabling mental health disorder that impacts the lives of individuals. This study aims to understand nitrous oxide's effects in PTSD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitrous Oxide
Arm Type
Experimental
Arm Description
PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Intervention Description
One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation
Primary Outcome Measure Information:
Title
Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Description
Patients given CAPS-5 (Clinician Administered PTSD Scale for DSM-5), a 30-item structured interview that can be used to assess PTSD symptoms over the past week. For the CAPS-5 the minimum units are 0 and maximum units on the total scale are 80. The higher the number on the CAPS-5, the more severe the symptoms. Response was defined as at least a 12 point reduction on the CAPS-5
Time Frame
Baseline and 1 week post inhalation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-80
Veterans of the United States Uniformed Services
primary diagnosis of PTSD
sufficient severity of PTSD symptoms
fluency in English
capacity to provide informed consent
Exclusion Criteria:
psychiatric or medical conditions that make participation unsafe
pregnant or nursing females
allergy to nitrous oxide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Rodriguez, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32609959
Citation
Varias A, van Roessel P, Parsiani M, Filippou-Frye M, Neylan TC, Nagele P, Yesavage J, Clark JD, Rodriguez CI. Does Nitrous Oxide Help Veterans With Posttraumatic Stress Disorder? A Case Series. J Clin Psychiatry. 2020 Jun 30;81(4):20l13393. doi: 10.4088/JCP.20l13393. No abstract available.
Results Reference
derived
Links:
URL
http://rodriguezlab.stanford.edu
Description
Rodriguez Lab Website
Learn more about this trial
Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
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