Group MDMA-therapy for Veterans With PTSD

NCT ID: NCT05961527

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-03-14

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.

Detailed Description

To assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor-investigator is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly open-label MDMA Sessions combined with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Clinical Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.

Conditions

PTSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MDMA-assisted group therapy

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

Group Type: EXPERIMENTAL

MDMA

Intervention Type: 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

Group Therapy

Intervention Type: BEHAVIORAL

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

Interventions

MDMA

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

Intervention Type: DRUG

Group Therapy

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

Intervention Type: BEHAVIORAL

Other Intervention Names

3,4-methylenedioxymethamphetamine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steven & Alexandra Cohen Foundation

OTHER

Sponsor Role: collaborator

Portland VA Research Foundation, Inc

OTHER

Sponsor Role: lead

Responsible Party

Christopher Stauffer

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Portland-Vancouver VA

Vancouver, Washington, United States

Countries

United States

Other Identifiers

02

Identifier Type: -

Identifier Source: org_study_id