Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
tN2O
1 other identifier
interventional
3
1 country
1
Brief Summary
The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2020
CompletedResults Posted
Study results publicly available
July 16, 2020
CompletedJuly 24, 2020
July 1, 2020
1.3 years
December 12, 2017
June 26, 2020
July 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline and 1 week post inhalation
Study Arms (1)
Nitrous Oxide
EXPERIMENTALPTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour
Interventions
One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- psychiatric or medical conditions that make participation unsafe
- pregnant or nursing females
- allergy to nitrous oxide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veterans Affairs Palo Alto
Palo Alto, California, 94304, United States
Related Publications (1)
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.
PMID: 32609959DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carolyn Rodriguez
- Organization
- Palo Alto Veterans Affairs
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Rodriguez, MD, PhD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 18, 2017
Study Start
April 1, 2018
Primary Completion
July 31, 2019
Study Completion
April 5, 2020
Last Updated
July 24, 2020
Results First Posted
July 16, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share