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

NCT ID: NCT03375294

Last Updated: 2020-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-04-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nitrous Oxide

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

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

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

Interventions

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Nitrous Oxide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Carolyn Rodriguez

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn Rodriguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Veterans Affairs Palo Alto

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32609959 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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41822

Identifier Type: -

Identifier Source: org_study_id

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