NCT06954025

Brief Summary

This study will evaluate the feasibility, safety and efficacy of high-intensity inpatient MDMA-assisted psychotherapy for treatment-refractory posttraumatic stress disorder.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
May 2025Jan 2027

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

April 24, 2025

Last Update Submit

July 23, 2025

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

MDMA-assisted psychotherapyPosttraumatic stress disorder3,4-MethylenedioxymethamphetamineMidomafetaminePsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R)

    The last month CAPS-5-R is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event and time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The CAPS-5-R rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The CAPS-5-R will be administered by a study independent CAPS rater.

    From Baseline to 1 month after final integrative psychotherapy session

Secondary Outcomes (1)

  • Sheehan Disability Scale

    From Baseline to 1 month after final integrative psychotherapy session

Study Arms (1)

MDMA-assisted psychotherapy

EXPERIMENTAL

High-intensity MDMA-assisted psychotherapy within an inpatient setting

Drug: High-intensity inpatient MDMA-assisted psychotherapy

Interventions

High-intensity inpatient MDMA-assisted psychotherapyDRUG

Drug: 3,4-methylenedioxymethamphetamine (MDMA) Session 1: 80 mg MDMA HCl followed by a supplemental dose of 40 mg Session 2: 120 mg MDMA HCl followed by a supplemental dose of 60 mg Psychotherapy: manualized psychotherapy

MDMA-assisted psychotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old.
  • Able to provide written informed consent.
  • Fluent in speaking and reading Dutch.
  • Able to swallow pills.
  • Body weight of at least 48 kg.
  • Meet DSM-5 criteria for current PTSD.
  • Meet criteria for treatment-refractory PTSD.
  • Currently in treatment at ARQ Centre'45.
  • Agree to have study visits audiovisually recorded.
  • 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.

You may not qualify if:

  • Has a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate.
  • Has uncontrolled hypertension.
  • Has a recent history of clinically significant hyponatremia or hyperthermia.
  • Has current unstable liver or biliary disease.
  • Unable or unwilling to safely taper-off prohibited psychiatric medication.
  • Has engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including Electroconvulsive Therapy (ECT).
  • Has a medical or psychiatric condition that could interfere with study participation or pose a risk to the participant's safety or well-being.
  • Has any current problem which, in the opinion of the investigator, might interfere with study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ARQ National Psychotrauma Centre / ARQ Centrum'45

Oegstgeest, 2342EG, Netherlands

Location

Related Publications (5)

  • Van Woudenberg C, Voorendonk EM, Bongaerts H, Zoet HA, Verhagen M, Lee CW, van Minnen A, De Jongh A. Effectiveness of an intensive treatment programme combining prolonged exposure and eye movement desensitization and reprocessing for severe post-traumatic stress disorder. Eur J Psychotraumatol. 2018 Jul 10;9(1):1487225. doi: 10.1080/20008198.2018.1487225. eCollection 2018.

    PMID: 30013726BACKGROUND

  • Zepeda Mendez M, Nijdam MJ, Ter Heide FJJ, van der Aa N, Olff M. A five-day inpatient EMDR treatment programme for PTSD: pilot study. Eur J Psychotraumatol. 2018 Feb 5;9(1):1425575. doi: 10.1080/20008198.2018.1425575. eCollection 2018.

    PMID: 29441152BACKGROUND

  • Feduccia AA, Jerome L, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Front Psychiatry. 2019 Sep 12;10:650. doi: 10.3389/fpsyt.2019.00650. eCollection 2019.

    PMID: 31572236BACKGROUND

  • Mitchell JM, Ot'alora G M, van der Kolk B, Shannon S, Bogenschutz M, Gelfand Y, Paleos C, Nicholas CR, Quevedo S, Balliett B, Hamilton S, Mithoefer M, Kleiman S, Parker-Guilbert K, Tzarfaty K, Harrison C, de Boer A, Doblin R, Yazar-Klosinski B; MAPP2 Study Collaborator Group. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023 Oct;29(10):2473-2480. doi: 10.1038/s41591-023-02565-4. Epub 2023 Sep 14.

    PMID: 37709999BACKGROUND

  • Mitchell JM, Bogenschutz M, Lilienstein A, Harrison C, Kleiman S, Parker-Guilbert K, Ot'alora G M, Garas W, Paleos C, Gorman I, Nicholas C, Mithoefer M, Carlin S, Poulter B, Mithoefer A, Quevedo S, Wells G, Klaire SS, van der Kolk B, Tzarfaty K, Amiaz R, Worthy R, Shannon S, Woolley JD, Marta C, Gelfand Y, Hapke E, Amar S, Wallach Y, Brown R, Hamilton S, Wang JB, Coker A, Matthews R, de Boer A, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021 Jun;27(6):1025-1033. doi: 10.1038/s41591-021-01336-3. Epub 2021 May 10.

    PMID: 33972795BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

May 16, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)