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MDMA-Assisted Massed Exposure Therapy for PTSD

ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-70
SponsorEmory University

About this trial

The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants.

The main questions it aims to answer are:

* Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo? * Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo? * Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes?

Participants will:

* Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks * Be administered either 100 mg of MDMA or a placebo at Visit 2 * Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale for DSM-5 - Revised (CAPS-5-R).

Able to speak and read English (due to standardization of outcome measures).

Willing to sign a release for the investigators to communicate with their primary care or mental health providers if indicated.

Able to swallow pills.

Disqualifiers

Are not able to give adequate informed consent.

Have previously participated in a Multidisciplinary Association for Psychedelic Studies (MAPS) sponsored MDMA clinical trial.

Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.

Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3,4-Methylenedioxymethamphetamine (MDMA)

    Drug

    MDMA is a synthetic compound, commonly administered as MDMA hydrochloride (HCl). The drug will be administered in 100mg doses for a single session on Visit 2 out of 10- day study sessions over 2 weeks. MDMA is administered orally in capsule form and is taken under supervision in a controlled, therapeutic environment

  • Placebo

    Drug

    Placebos will visually match the 3 MDMA capsules (40mg, 40mg, and 20mg).

  • Massed Prolonged Exposure (PE)

    Behavioral

    Massed exposure therapy will be conducted for 11 sessions, 10 daily sessions and an additional therapy session during V2. They will consist of repeated exposures to trauma memories (imaginal exposure) consistent with the manualized protocol for massed exposure therapy. Also consistent with this treatment manual, participants will listen to imaginal exposures outside of PE sessions for "homework."

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: MDMA groupExperimental treatment 2 interventions
Group B: Standard of CarePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Changes in PTSD symptoms measured by CAPS-5-R

The CAPS-5-R is a structured clinical interview used to assess PTSD symptoms based on DSM-5 criteria. Each symptom is rated on frequency and intensity * Combined into a severity score per item * Total score reflects overall PTSD symptom severity

Time frame
Baseline, 1 month post-treatment

Secondary outcomes

1

Changes in PTSD symptoms measured by PCL-5

The PCL-5 is a 20-item self-report questionnaire used to measure PTSD symptoms based on DSM-5 criteria. Participants rate how much they've been bothered by each symptom in relation to a specific traumatic event, using a scale from 0 ("Not at all") to 4 ("Extremely"). A total score of 33 or higher indicates clinically elevated PTSD symptoms

Time frame
Baseline, 1 month post treatment
2

Change in PHQ questionnaire scores

The PHQ-9 is a questionnaire used to assess depression severity. Each of the 9 items is scored from 0 to 3, giving a total score between 0 and 27. Higher scores suggest more severe depressive symptoms.

Time frame
Baseline, 1 month post-treatment

Other outcomes

1

Changes in fMRI-based neural activation patterns

Participants will view 15 blocks of fearful face stimuli and 15 blocks of neutral face stimuli, with emotion condition randomly interweaved. Within each block, 8 face stimuli will be presented for 500 ms each, followed by a 500 ms intertrial interval. Changes in fMRI-based neural activation patterns following MDMA-assisted massed exposure therapy will be reported.

Time frame
Day 1 of treatment, Day 10 of treatment
2

Changes in fear extinction retention

This will be assessed via a Pavlovian fear conditioning/extinction paradigm in which colored shapes are presented visually and paired with a 250 millisecond air blast. Changes in fear extinction retention following MDMA-assisted massed exposure therapy will be reported

Time frame
Day 4, Day 10 of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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