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NCT03375294 Clinical Trial

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

Post Traumatic Stress Disorder Clinical Trial

— tN2O  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03375294
Other study ID # 41822
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 1, 2018
Est. completion date April 5, 2020

Study information
Verified date July 2020
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date April 5, 2020
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Veterans Affairs Palo Alto Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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