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

Phase 2

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Drug: Nitrous Oxide

• Registration Number: NCT03375294
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Study Start: 2018-04-01
• Primary Completion: 2019-07-31
• Study Completion: 2020-04-05
• Results First Submitted: 2020-06-26
• Results First Submitted QC: 2020-06-26
• Status Verified: 2020-07
• Results First Posted: 2020-07-16
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitrous Oxide	Nitrous Oxide	PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour

Primary Outcome Measures

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

Trial Locations

Locations (1)

Veterans Affairs Palo Alto; 🇺🇸 Palo Alto, California, United States