Group MDMA-therapy for Veterans With PTSD

NCT05961527 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.

Conditions

PTSD

Keywords

MDMA; PTSD; Veterans; Group Therapy

Outcome Measures

Primary Outcomes (1)

• Change in CAPS-5 Total Severity Score

  The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

  Baseline - 3 months from first Experimental Session

Secondary Outcomes (1)

• Change in Sheehan Disability Scale (SDS)

  Baseline - 3 months from first Experimental Session

Study Arms (1)

MDMA-assisted group therapy

EXPERIMENTAL

Four Preparatory Sessions, two MDMA Sessions, and four Integrative Sessions following each MDMA Session.

Drug: MDMA; Behavioral: Group Therapy

Interventions

MDMA DRUG

Initial dose of 120 mg MDMA HCL and optional supplemental dose of 60 mg MDMA HCL at 1.5 to 2 hours after first dose

Also known as: 3,4-methylenedioxymethamphetamine

MDMA-assisted group therapy

Group Therapy BEHAVIORAL

Standardized group psychotherapy performed by therapist team in combination with non-directive MDMA therapy

MDMA-assisted group therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Are at least 18 years old.
• Are a U.S. Military Veteran
• Are fluent in speaking and reading the predominantly used or recognized language of the study site.
• Are able to swallow pills.
• Agree to have study visits recorded, including MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions.
• Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
• Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
• If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
• Must not participate in any other interventional clinical trials during the duration of the study.
• Must commit to medication dosing, therapy, and study procedures.
• Have a current PTSD diagnosis at the time of screening.

You may not qualify if:

• Are not able to give adequate informed consent.
• Have uncontrolled hypertension.
• Have a marked baseline QTcF interval \>450 milliseconds \[ms\] demonstrated on repeated ECG assessments.
• Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• Have evidence or history of significant medical disorders.
• Have symptomatic liver or biliary disease.
• Have history of hyponatremia or hyperthermia.
• Weigh less than 48 kilograms (kg).
• Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
• Are abusing illegal drugs or alcohol.

Sponsors & Collaborators

• Portland VA Research Foundation, Inc: lead
• Steven & Alexandra Cohen Foundation: collaborator

Study Sites (1)

Portland-Vancouver VA

Vancouver, Washington, 98661, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Psychotherapy, Group

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Independent raters for the primary clinical outcome will be blinded to study design and timepoint.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: Open-label study examining safety and feasibility of MDMA-assisted group therapy

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: October 1, 2023
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)