Post Traumatic Stress Disorder
Conditions
Keywords
PTSD
Brief summary
The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)
Detailed description
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.
Interventions
DRUGNitrous Oxide
One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline and 1 week post inhalation | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Nitrous Oxide |
|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nitrous Oxide | Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 2 Participants |