Trial Outcomes & Findings for Nitrous Oxide for PTSD (NCT NCT04378426)

Last Updated: 2023-03-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

1 week

Results posted on

2023-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitrous Oxide for PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitrous Oxide n=1 Participants 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	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	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	49 years STANDARD_DEVIATION 0 • n=99 Participants	—	49 years STANDARD_DEVIATION 0 • n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants	—	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	—	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Region of Enrollment United States	1 participants n=99 Participants	—	1 participants n=206 Participants
CAPS 5	64 units on a scale STANDARD_DEVIATION 0 • n=99 Participants	—	64 units on a scale STANDARD_DEVIATION 0 • n=206 Participants

PRIMARY outcome

Timeframe: 1 week

Population: 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.

Outcome measures

Outcome measures
Measure	Nitrous Oxide n=1 Participants 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	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
Improvement in the Severity of PTSD as Measured by the Clinician Administered PTSD Scale DSM5 (CAPS-5)	46 units on a scale Standard Deviation 0	—

Adverse Events

Nitrous Oxide

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nitrous Oxide n=1 participants at risk 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	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
Gastrointestinal disorders nausea	100.0% 1/1 • 1 week Only 1 participant was recruited before the study was terminated.	— 0/0 • 1 week Only 1 participant was recruited before the study was terminated.
Nervous system disorders dizziness	100.0% 1/1 • 1 week Only 1 participant was recruited before the study was terminated.	— 0/0 • 1 week Only 1 participant was recruited before the study was terminated.
Nervous system disorders poor coordination	100.0% 1/1 • 1 week Only 1 participant was recruited before the study was terminated.	— 0/0 • 1 week Only 1 participant was recruited before the study was terminated.
Nervous system disorders poor concentration	100.0% 1/1 • 1 week Only 1 participant was recruited before the study was terminated.	— 0/0 • 1 week Only 1 participant was recruited before the study was terminated.
Nervous system disorders fatigue	100.0% 1/1 • 1 week Only 1 participant was recruited before the study was terminated.	— 0/0 • 1 week Only 1 participant was recruited before the study was terminated.
Nervous system disorders general malaise	100.0% 1/1 • 1 week Only 1 participant was recruited before the study was terminated.	— 0/0 • 1 week Only 1 participant was recruited before the study was terminated.
Nervous system disorders tingling in toes	100.0% 1/1 • 1 week Only 1 participant was recruited before the study was terminated.	— 0/0 • 1 week Only 1 participant was recruited before the study was terminated.

Additional Information

Carolyn Rodriguez, MD, PhD

Palo Alto VA

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place