Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)

The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)

Completed

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Veterans Affairs Palo Alto

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrous Oxide

Drug

One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation

Primary outcomes

Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Time frame: Baseline and 1 week post inhalation

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: tN2O

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Dec 18, 2017
Registry last updated: Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed