Trial Outcomes & Findings for Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD) (NCT NCT03375294)

Last Updated: 2020-07-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline and 1 week post inhalation

Results posted on

2020-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitrous Oxide n=3 Participants 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
Age, Continuous	40 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 week post inhalation

Population: 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)

Outcome measures

Outcome measures
Measure	Nitrous Oxide n=3 Participants 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
Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	2 Participants

Adverse Events

Nitrous Oxide

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nitrous Oxide n=3 participants at risk 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
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • 1 week Does not differ.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders Poor concentration	66.7% 2/3 • Number of events 2 • 1 week Does not differ.
Gastrointestinal disorders Decreased energy	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders General malaise	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders Fingers tingling	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders Body warmth	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders Increased perspiration	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Eye disorders Blurry vision	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders Restlessness	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • 1 week Does not differ.
Nervous system disorders Fatigue	33.3% 1/3 • Number of events 1 • 1 week Does not differ.

Additional Information

Dr. Carolyn Rodriguez

Palo Alto Veterans Affairs

Phone: 650-723-6158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place