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| ID | Type | Description | Link |
|---|---|---|---|
| I01CX001789 | U.S. NIH Grant/Contract | View source | |
| 53017 | Other Identifier | IRB |
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Use of VA hospital research space is indefinitely delayed due to prioritization of clinical cases delayed by COVID
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Post-traumatic stress disorder (PTSD) seriously disrupts the lives of many Veterans. Current first-line treatments, serotonin reuptake inhibitors or prolonged exposure therapy, take weeks to months to bring meaningful improvement, leaving Veterans experiencing prolonged suffering. A promising new treatment approach for rapidly reducing PTSD symptoms is nitrous oxide, an inhalation anesthetic and putative glutamate modulator that diminishes depression symptoms within 1 day and has limited side effects. If shown to be similarly effective in PTSD, nitrous oxide may add dramatically to the treatment armamentarium by bringing rapid symptom decrease before longer-term therapies take hold. The proposed projects test the efficacy of nitrous oxide in relieving Veteran's PTSD symptoms and, in parallel, explore how nitrous oxide may modify cognitive and pain outcomes.
The proposed projects will examine the efficacy of nitrous oxide in relieving Veteran's PTSD symptoms and in parallel, explore whether nitrous oxide improves cognitive and pain outcomes. Specifically, the investigators will first assess whether nitrous oxide treatment improves PTSD symptoms within 1 week. In parallel, the investigators will explore whether the treatment improves co-existing depression and pain. In addition, the investigators will explore nitrous oxide's effects on a PTSD-associated impairment that is often overlooked - disruption in cognitive control, a core neurobiological process critical for regulating thoughts and for successful daily functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous Oxide | Experimental | PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline |
|
| Midazolam | Active Comparator | PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous Oxide | Drug | PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the Severity of PTSD as Measured by the Clinician Administered PTSD Scale DSM5 (CAPS-5) | Improvement in PTSD severity is measured by the Clinician Administered PTSD Scale DSM-5 (CAPS-5). It measures frequency and intensity of PTSD-related symptoms. For the CAPS-5 the minimum units are 0 and maximum units are 80. The higher the number on the CAPS-5, the more severe the PTSD symptoms. Response is defined as a change in the CAPS-5 of at least 12 points, which represents meaningful improvement in clinical PTSD symptoms. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn I Rodriguez, MD PhD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States |
No data will be shared without approval of sponsor and IRB.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitrous Oxide | PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline Nitrous Oxide: PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline Oxygen: inhaled gas Saline: Placebo infusion |
| FG001 | Midazolam | PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Midazolam: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Nitrogen: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Oxygen: inhaled gas |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study discontinued due to unsufficient space due to backlog of clinical patients due to COVID
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitrous Oxide | PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline Nitrous Oxide: PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline Oxygen: inhaled gas Saline: Placebo infusion |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Improvement in the Severity of PTSD as Measured by the Clinician Administered PTSD Scale DSM5 (CAPS-5) | Improvement in PTSD severity is measured by the Clinician Administered PTSD Scale DSM-5 (CAPS-5). It measures frequency and intensity of PTSD-related symptoms. For the CAPS-5 the minimum units are 0 and maximum units are 80. The higher the number on the CAPS-5, the more severe the PTSD symptoms. Response is defined as a change in the CAPS-5 of at least 12 points, which represents meaningful improvement in clinical PTSD symptoms. | The study was terminated in partnership with program officer given that the nitrous oxide administration space in the hospital (which had been used pre-pandemic) is longer available - it is being used exclusively for clinical care to keep up with the clinical backlog of cases due to the pandemic. This delay will continue for the foreseeable future. COVID-19 has had far-reaching impact on the feasibility of the study, which will not meet its recruitment goal in the foreseeable future. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
1 week
Only 1 participant was recruited before the study was terminated.
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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 participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline Nitrous Oxide: PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline Oxygen: inhaled gas Saline: Placebo infusion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
The study was terminated in partnership with program officer given that the nitrous oxide administration space in the hospital (which had been used pre-pandemic) is longer available - it is being used exclusively for clinical care to keep up with the clinical backlog of cases due to the pandemic. This delay will continue for the foreseeable future. COVID-19 has had far-reaching impact on the feasibility of the study, which will not meet its recruitment goal in the foreseeable future.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Rodriguez, MD, PhD | Palo Alto VA | 650-493-5000 | 60067 | carolyn.rodriguez@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2022 | Jan 18, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2023 | Jan 18, 2023 | SAP_003.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 |
| D008874 | Midazolam |
| D009584 | Nitrogen |
| D010100 | Oxygen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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Randomized placebo-controlled clinical trial including two groups: Experimental (admixture of up to 50% nitrous oxide and 50% oxygen plus IV saline) and Active Comparator (admixture of up to 50% nitrogen and 50% oxygen plus 0.045mg/kg midazolam).
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Blinding Protections: First, the investigators will separate personnel and location of the team providing study drug from the team performing psychiatric evaluations. Independent evaluators (IEs) blind to treatment assignment will assess participants . Second, records for drug administration will be kept separate from psychiatric assessment case report forms until completion of the study. Third, all participants will be blinded as to the nature of the inhaled gas and IV drug at each session; all participants will be informed that they will receive either nitrous oxide and IV saline or an air mixture with a high nitrogen component and IV midazolam. Integrity of the blinding will be assessed by recording each patient's guess as to which drug was received.
| Midazolam | Drug | PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam |
|
| Nitrogen | Drug | PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam |
|
| Oxygen | Drug | inhaled gas |
|
| Saline | Drug | Placebo infusion |
|
| Midazolam |
PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Midazolam: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Nitrogen: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Oxygen: inhaled gas |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CAPS 5 | For the CAPS-5 the minimum units are 0 and maximum units are 80. The higher the number on the CAPS-5, the more severe the PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
| OG000 | Nitrous Oxide | PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline Nitrous Oxide: PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline Oxygen: inhaled gas Saline: Placebo infusion |
| OG001 | Midazolam | PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Midazolam: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Nitrogen: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Oxygen: inhaled gas |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Midazolam | PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Midazolam: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Nitrogen: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam Oxygen: inhaled gas | 0 | 0 | 0 | 0 | 0 | 0 |
| dizziness | Nervous system disorders | Systematic Assessment |
|
| poor coordination | Nervous system disorders | Systematic Assessment |
|
| poor concentration | Nervous system disorders | Systematic Assessment |
|
| fatigue | Nervous system disorders | Systematic Assessment |
|
| general malaise | Nervous system disorders | Systematic Assessment |
|
| tingling in toes | Nervous system disorders | Systematic Assessment |
|
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| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004602 | Elements |
| D018011 | Chalcogens |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |