MDMA-Assisted Psychotherapy for PTSD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Southern California

Must not be taking: Psychiatric medications

Disqualifiers: Psychotic disorder, Bipolar, Eating disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether MDMA-assisted psychotherapy can aid individuals with PTSD (Post-Traumatic Stress Disorder) by examining changes in stress-related genes. Participants will undergo therapy sessions with either MDMA (a psychoactive drug) or a placebo. The study involves collecting saliva samples to determine if the treatment affects genetic markers linked to stress and if these changes correlate with improvements in PTSD symptoms. Individuals with severe PTSD for more than six months and significant symptoms might be suitable candidates. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for PTSD.

Do I need to stop taking my current medications for the trial?

The trial requires participants to refrain from certain medications before the Experimental Sessions, but it does not specify which ones. It's best to discuss your current medications with the trial investigators to see if any adjustments are needed.

Is there any evidence suggesting that MDMA-Assisted Psychotherapy is likely to be safe for humans?

Research has shown that MDMA-assisted therapy is generally safe and well-tolerated. In a study on individuals with moderate to severe PTSD, no deaths or serious side effects related to the treatment occurred. This finding suggests that the therapy is relatively safe for participants.

Earlier studies showed promising results, prompting the FDA to grant MDMA-assisted therapy a special status in 2017. This status is awarded to treatments that demonstrate great potential and a good safety record.

Overall, extensive research supports the safety of MDMA-assisted therapy for treating PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

MDMA-Assisted Psychotherapy is unique because it combines therapy with doses of MDMA, a psychoactive substance, to enhance the therapeutic process for treating PTSD. Unlike traditional treatments like SSRIs or cognitive behavioral therapy, which can take weeks to show results, MDMA may allow patients to process traumatic memories more effectively and rapidly. Researchers are excited because this approach could offer a novel and potentially more efficient way to manage PTSD symptoms by fostering a safe emotional environment and improving therapy outcomes.

What evidence suggests that MDMA-Assisted Psychotherapy could be an effective treatment for PTSD?

Research has shown that therapy using MDMA can greatly reduce PTSD symptoms. In some studies, after three sessions with MDMA, 67% to 71% of participants no longer had PTSD. These trials found that people with moderate to severe PTSD experienced fewer symptoms and improved daily functioning. The benefits were not just short-term; some individuals continued to improve months after treatment. In this trial, participants will receive either MDMA-assisted psychotherapy or placebo-assisted psychotherapy. These promising results led the FDA to grant this therapy "breakthrough" status, highlighting its potential as an effective treatment. ^{2 3 6 7 8}

Who Is on the Research Team?

Rael Cahn, MD, PhD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for individuals with Post-Traumatic Stress Disorder (PTSD) who are already participating in a Phase 3 study of MDMA-Assisted Psychotherapy. Participants will provide saliva samples to explore if the therapy affects stress-related genes.

Inclusion Criteria

At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of 6 months or longer

I can fluently speak and read the main language used at the study site.

I have severe PTSD symptoms with a PCL-5 score of 50 or more.

Exclusion Criteria

Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial

I need medications that can affect my heart's electrical cycle during the trial.

Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Psychotherapy

Participants undergo 3 preparatory psychotherapy visits before treatment sessions

3 weeks

3 visits (in-person)

Treatment

Participants receive MDMA or placebo during 3 treatment sessions with psychotherapy

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 3 follow-up psychotherapy visits

3 weeks

3 visits (in-person)

Saliva Collection

Saliva samples are collected at baseline and after the final treatment session to assess epigenetic changes

18 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MDMA-Assisted Psychotherapy

Trial Overview The substudy tests whether MDMA-assisted psychotherapy can influence epigenetic markers in saliva that relate to stress. It's an addition to a larger study comparing this treatment with placebo-assisted psychotherapy over several sessions.

How Is the Trial Designed?

Group I: MDMA Assisted Psychotherapy Active Control 2 Interventions

A longitudinal course of psychotherapy with administration of MDMA on two occasions to assist with the psychotherapeutic process

Group II: Placebo Assisted Psychotherapy Placebo Group 1 Intervention

A longitudinal course of psychotherapy with administration of placebo on two occasions to assist with the psychotherapeutic process

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Lykos Therapeutics

Collaborator

Trials

12

Recruited

330+

Multidisciplinary Association for Psychedelic Studies

Collaborator

Trials

40

Recruited

1,200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39955464/

MDMA-Assisted Therapy for Post-Traumatic Stress Disorder Early-phase clinical trials of MDMA-assisted therapy (MDMA-AT) showed promising results, leading the FDA to grant breakthrough therapy status to MDMA-AT in 2017 ...

2. nature.com nature.com/articles/s41591-023-02565-4

MDMA-assisted therapy for moderate to severe PTSD These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD and was generally well ...

3. icer.org icer.org/wp-content/uploads/2024/06/PTSD_Final-Report_For-Publication_06272024.pdf

Midomafetamine-Assisted Psychotherapy for Post- ... Differences in trial design, measured outcomes, and data availability with previous phase II trials on MDMA-AP led to the exclusion of these ...

4. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10.1191

The effectiveness and value of midomafetamine-assisted ... Trial participants showed reduced PTSD symptoms 2 months posttreatment, with long-term follow-up data indicating sustained benefits for MDMA-AP- ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20230681

MDMA and MDMA-Assisted Therapy | American Journal of ... After a course of MDMA-AT involving three MDMA administrations supported by psychotherapy, 67%–71% of individuals with PTSD no longer meet ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660711/

MDMA-Based Psychotherapy in Treatment-Resistant Post ... MDMA can reduce PTSD symptoms even in treatment-resistant cases by increasing certain neurohormones, ie, dopamine, serotonin, norepinephrine, and oxytocin.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124003287

The efficacy and safety of MDMA-assisted psychotherapy ... This study aimed to systematically review and demonstrate the efficacy and safety of MDMA-assisted psychotherapy for the treatment of PTSD.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06954025

High-Intensity Inpatient MDMA-Assisted Psychotherapy for ... This study will evaluate the feasibility, safety and efficacy of high-intensity inpatient MDMA-assisted psychotherapy for treatment-refractory posttraumatic ...