Recruiting
Phase 2

MDMA-Assisted Therapy

Sponsor:

Stephen Robert Marder

Code:

NCT05790239

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3,4-methylenedioxymethamphetamine

d-amphetamine

Therapy

Study Details

Brief summary:

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

Study ID

NCT05790239

Start date

Mar 1, 2025

Status verified date

Aug, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MDMA-Assisted Therapy

Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.

active comparator: Low Dose D-Amphetamine Assisted Therapy

Participants will receive a flexible divided dose plus therapy at Experimental Sessions.

Interventions

3,4-methylenedioxymethamphetamine

Initial doses per Experimental Session include 68 mg or 100 mg MDMA (equivalent to 80 mg or 120 mg MDMA HCl), followed 1.5 to 2 hours later by a supplemental dose of 34 mg or 50 mg MDMA (equivalent to 40 mg or 60 mg MDMA HCl).

d-amphetamine

Initial dose per experimental session will be 5 mg or 10 mg d-amphetamine, followed 1.5 to 2 hours later by supplemental dose of 2.5 mg or 5 mg d-amphetamine.

Therapy

Participants assigned to MDMA and d-amphetamine will undergo a therapeutic approach, which is detailed in the MDMA-Assisted Therapy Treatment Manual and administered by MAPS-trained therapists. In brief, this therapy is guided by the subject's own recollections of traumatic events. The subject and two therapists provide a comfortable and supportive environment and allow the subject to guide the discussion. Subjects are encouraged to experience and express fear, anger, and grief with less likelihood of feeling overwhelmed by these emotions. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. In addition, feelings of empathy, love, and deep appreciation often emerge, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present.

Primary outcome measure

  • Compare changes in PTSD symptom severity in the MDMA vs active control group. [ Time Frame: Visit 17 (approximately 14 weeks after enrollment) ]

Central Contacts and Locations

Central contacts

Stephanie L Taylor, PhD

213-505-1140Stephanie.Taylor8@va.gov

Stephen Marder, MD

Stephen.Marder@va.gov

Locations

West Los Angeles Veteran Affairs

Recruiting

Los Angeles, California, United States, 90095

Contacts

Gerard DeVera, BA

310-478-3711Gerard.Devera@va.gov

Gerard De Vera

310-478-3711gerard.devera@va.gov

More Information

Sponsor

Stephen Robert Marder

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stephen Robert Marder on 2026-08-19.