Nitrous Oxide for PTSD (N2OP)

VA Office of Research and Development

Status and phase: Terminated; Phase 2

Conditions: PTSD

Treatments: Drug: Oxygen; Drug: Nitrogen; Drug: Nitrous Oxide; Drug: Midazolam; Drug: Saline

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04378426

53017 (Other Identifier)

MHBB-009-19S

I01CX001789 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veteran
• primary diagnosis of PTSD
• sufficient severity of PTSD symptoms
• capacity to provide informed consent

Exclusion criteria

• psychiatric or medical conditions that make participation unsafe
• pregnant or nursing females
• concurrent use of any medications that might increase the risk of participation (e.g. drug interactions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 2 patient groups

Nitrous Oxide

Experimental group

Description:

PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline

Treatment:

Drug: Nitrous Oxide

Drug: Oxygen

Drug: Saline

Midazolam

Active Comparator group

Description:

PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam

Treatment:

Drug: Oxygen

Drug: Nitrogen

Drug: Midazolam