MDMA-AT for PTSD in Young Adults With Childhood Trauma

ConditionPosttraumatic Stress Disorder (PTSD)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-26

SponsorJenna M. Traynor

About this trial

This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT).

The main questions it aims to answer are:

* Is the treatment safe and feasible to administer? * Does the treatment improve PTSD symptoms?

Participants will be asked to:

* Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation * Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session * Attend three integration talk therapy sessions after each MDMA-AT dosing session * Attend up to three total MDMA-AT dosing sessions * Complete assessments from baseline to 38-weeks post-baseline * Complete a fMRI scan at baseline and at 18-weeks post-treatment * Complete self-report measures and ecological momentary assessments (EMAs) across the study period

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 18-26 years old upon signing the written consent form

Proficient in speaking and reading English.

Capable of providing informed consent.

Is able to swallow pills.

Disqualifiers

Recently attempted suicide or engaged in high risk self-injury or is otherwise assessed to be at imminent risk of suicide by study staff

In the opinion of the PI, would present a serious risk to others as established through study screening measures or clinical observations.

Meets DSM-5 criteria for any current substance use disorder, other than alcohol, cannabis, or nicotine use disorder

For cannabis use and alcohol use disorders without physiological dependence, must agree to be abstinent from alcohol and cannabis for one week prior to and following each MDMA-AT session.

Trial design

Design model

Single group

Treatments tested in this trial

MDMA assisted psychotherapy
Drug
Recruiting young adults with PTSD for an interventional study testing a combination of MDMA and talk therapy.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Experimental: MDMA-AT for PTSDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest

The safety of MDMA-AT will be assessed by the number, type, and severity of adverse events.

Time frame

Assessed from baseline to 18-weeks post baseline, and again at two follow-up timepoints (26- and 38-weeks post-baseline).

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

The efficacy of MDMA-AT will be assessed using the CAPS-5 total severity score. The CAPS-5 is a 30-item structured clinical interview used to diagnose PTSD, including overall PTSD severity. The severity score ranges from 0 to 80, with higher scores indicating greater overall severity of PTSD symptoms

Time frame

From baseline to 18-weeks post-baseline.

Secondary outcomes

The PTSD Checklist for DSM-5 (PCL-5)

The PCL-5 is a 20-item self-report measure of PTSD symptom severity. Responses range from 0 (not at all) to 4 (extremely), and total scores range from 0-80, with higher scores indicating greater PTSD symptom severity.

Time frame

From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

The Inventory of Altered Self Capacities (IASC)

The IASC is a 63-item self-report measure of problems in identity, affect regulation, and interpersonal functioning. The scale produces a total score and seven subscores (representing Interpersonal Conflicts; Idealizing-Devaluing; Abandonment Concerns; Identity Impairment; Susceptibility to Influence; Emotion Dysregulation; and Tension Reduction Activities) representing common areas of impairment in individuals with PTSD as a result of childhood trauma.

Time frame

From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

Cognitive Flexibility Inventory (CFI)

The CFI is a 20-item self-report measure of adaptive cognitive responses to stressful life events. Responses range from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 20 and 140, where higher scores indicate more cognitive flexibility.

Time frame

From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

Self Compassion Scale Short Form (SCS-SF)

The SCS-SF is a 12-item self-report measure of self-kindness. It is made up of six Self Care items and the six Self Disparagement. Responses range from 1 (almost never) to 5 (almost always), with higher scores indicating high Self Care together with low Self Disparagement.

Time frame

From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

Other outcomes

Changes in functional connectivity

Examine changes in whole-brain, emotion-related and frontal-executive-related brain function using resting-state and task-based functional magnetic resonance imaging (fMRI).

Time frame

From baseline to 18-weeks post-baseline.

Ecological Momentary Assessments (EMAs)

Use EMAs to explore dynamic, longitudinal changes in additional PTSD-relevant domains of functioning (e.g., affect).

Time frame

Across 7 consecutive days leading up to and 10-days following each MDMA-AT session.

Sponsors and contacts

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

Jenna M. Traynor

Lead sponsor

Mclean Hospital

Sponsor institution

Source ClinicalTrials.gov

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