MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStephen Robert Marder

About this trial

This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.

Eligibility criteria

Qualifiers

At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.

Fluent in speaking and reading the predominantly used or recognized language of the study site (English).

Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.

Able to swallow pills.

Disqualifiers

Are not able to give adequate informed consent.

Have evidence or history of significant medical or psychiatric disorders.

Are abusing illegal drugs.

Unable or unwilling to safely taper off prohibited psychiatric medication.

Trial design

Treatments tested in this trial

  • 3,4-methylenedioxymethamphetamine
  • d-amphetamine
  • Therapy

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Stephen Robert Marder

Lead sponsor

VA Greater Los Angeles Healthcare System

Sponsor institution