RECRUITING

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

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Conditions

Post Traumatic Stress DisorderMDMAPTSDFunctional ImpairmentVeteranSubstance Use DisorderChronic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-01
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05790239

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.
  2. * Fluent in speaking and reading the predominantly used or recognized language of the study site (English).
  3. * Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.
  4. * Able to swallow pills.
  5. * Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.
  6. * 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.
  7. * Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.
  8. * 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.
  9. * May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
  10. * 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).
  11. * A person able to be pregnant (PABP) must use a highly effective contraceptive method.
  1. * Are not able to give adequate informed consent.
  2. * Have evidence or history of significant medical or psychiatric disorders.
  3. * Are abusing illegal drugs.
  4. * Unable or unwilling to safely taper off prohibited psychiatric medication.
  5. * 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.

Contacts and Locations

Study Contact

Stephanie L Taylor, PhD
CONTACT
213-505-1140
Stephanie.Taylor8@va.gov
Stephen Marder, MD
CONTACT
Stephen.Marder@va.gov

Principal Investigator

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

Study Locations (Sites)

VA Greater Los Angeles Healthcare System, Westwood campus
Los Angeles, California, 90073
United States
West Los Angeles Veteran Affairs
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • MDMA
  • Post Traumatic Stress Disorder
  • PTSD
  • Functional Impairment
  • Veteran
  • Substance Use Disorder
  • Chronic Pain

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder