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

Description

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.

Conditions

Post Traumatic Stress Disorder

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Study Overview

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Study Details

Study overview

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.

A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans for the Treatment of Moderate to Severe PTSD

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

Condition
Post Traumatic Stress Disorder
Intervention / Treatment

-

Contacts and Locations

Los Angeles

VA Greater Los Angeles Healthcare System, Westwood campus, Los Angeles, California, United States, 90073

Los Angeles

West Los Angeles Veteran Affairs, Los Angeles, California, United States, 90095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.
  • * Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.
  • * Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.
  • * May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.
  • * May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
  • * Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI must be within 18 to 32 kg/m2 (inclusive).
  • * A person able to be pregnant (PABP) must use a highly effective contraceptive method.
  • * 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.
  • * Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stephen Robert Marder,

Stephen Marder, MD, PRINCIPAL_INVESTIGATOR, VA Greater Los Angeles Healthcare System

Stephanie L Taylor, PhD, PRINCIPAL_INVESTIGATOR, VA Greater Los Angeles Healthcare System

Study Record Dates

2026-03