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Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD) (tN2O)

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ClinicalTrials.gov Identifier: NCT03375294
Recruitment Status : Completed
First Posted : December 18, 2017
Results First Posted : July 16, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Carolyn Rodriguez, Stanford University

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

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Nitrous Oxide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : April 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nitrous Oxide
PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour
Drug: Nitrous Oxide
One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375294


Locations
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United States, California
Veterans Affairs Palo Alto
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Carolyn Rodriguez, MD, PhD Stanford University
  Study Documents (Full-Text)

Documents provided by Carolyn Rodriguez, Stanford University:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carolyn Rodriguez, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03375294    
Other Study ID Numbers: 41822
First Posted: December 18, 2017    Key Record Dates
Results First Posted: July 16, 2020
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Carolyn Rodriguez, Stanford University:
PTSD
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents