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The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous Oxide | Experimental | PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous Oxide | Drug | One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Rodriguez, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Palo Alto | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32609959 | Derived | 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. |
| Label | URL |
|---|---|
| Rodriguez Lab Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitrous Oxide | PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitrous Oxide | PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 3 Veteran outpatients ages 31, 43, and 46 who met PTSD criteria of at least moderate symptoms severity (CAPS-5 score equal or greater than 40) | Posted | Count of Participants | Participants | Baseline and 1 week post inhalation |
|
1 week
Does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nitrous Oxide | PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Rodriguez | Palo Alto Veterans Affairs | 650-723-6158 | cr2163@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2020 | Jun 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Poor concentration | Nervous system disorders | Systematic Assessment |
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| Decreased energy | Gastrointestinal disorders | Systematic Assessment |
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| General malaise | Nervous system disorders | Systematic Assessment |
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| Fingers tingling | Nervous system disorders | Systematic Assessment |
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| Body warmth | Nervous system disorders | Systematic Assessment |
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| Increased perspiration | Nervous system disorders | Systematic Assessment |
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| Blurry vision | Eye disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Restlessness | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Fatigue | Nervous system disorders | Systematic Assessment |
|
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| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |