MDMA-Assisted Therapy for Post-Traumatic Stress Disorder

Not yet recruiting at 1 trial location

Overseen By Willa Hall, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nautilus Sanctuary

Must not be taking: QT prolonging drugs

Disqualifiers: Psychotic disorder, Bipolar I, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 to 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether MDMA-assisted therapy can help health care workers manage PTSD (post-traumatic stress disorder) from working during the COVID-19 pandemic. The study tests the safety and effectiveness of this treatment, which includes therapy sessions both with and without MDMA (a psychoactive drug). It is open to individuals who experienced stress in health care settings during the pandemic and reside near New York City. Participants must be able to swallow pills and have a close contact, such as a friend or family member, available for support if needed. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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

The trial requires you to refrain from certain medications before the Experimental Sessions, but it doesn't specify which ones. It's best to discuss your current medications with the study team to understand what changes might be needed.

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

Research has shown that MDMA-assisted therapy has been studied for treating post-traumatic stress disorder (PTSD) with promising results. In one study, 83% of participants who received MDMA-assisted therapy showed improvement, compared to 25% who received a placebo. Importantly, the drug did not cause any serious unwanted effects.

Another study found no deaths or serious unexpected problems in participants undergoing MDMA-assisted therapy. These findings suggest that MDMA-assisted therapy can reduce PTSD symptoms without causing severe side effects.

While these studies provide encouraging safety data, MDMA is still being tested for PTSD. Researchers continue to study its effects to ensure it is safe and effective for everyone. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

MDMA-assisted therapy is unique because it combines the psychoactive effects of MDMA with psychotherapy sessions to treat PTSD. Unlike traditional treatments like SSRIs or prolonged exposure therapy, which can take weeks or months to show improvement, MDMA may facilitate a more rapid emotional breakthrough by enhancing emotional processing and reducing fear responses during therapy sessions. Researchers are excited about this approach because it targets the root of traumatic memories, potentially offering more profound and lasting relief for PTSD sufferers.

What evidence suggests that MDMA-assisted therapy might be an effective treatment for PTSD?

Research shows that MDMA therapy can greatly reduce PTSD symptoms. Studies have found that MDMA boosts certain brain chemicals, such as serotonin and oxytocin, which lift mood and improve emotional connections. In one study, people with moderate to severe PTSD who received MDMA-assisted therapy experienced a noticeable drop in symptoms and felt better in their daily lives. Another study found that many participants had fewer symptoms or even reached remission, where symptoms disappeared. Overall, MDMA-assisted therapy appears promising for those with PTSD, especially when other treatments have not worked. ^{2 3 4 5 6}

Who Is on the Research Team?

Willa Hall, Ph.D.

Principal Investigator

Nautilus Sanctuary

Casey Paleos, M.D.

Principal Investigator

InnerMost PBC

Are You a Good Fit for This Trial?

This trial is for healthcare workers who have stress disorders from working during the COVID pandemic. They must be able to swallow pills, agree to recorded sessions, and have a contact in case of emergencies. Participants need to live within 60 miles of New York City, speak English fluently, and follow specific study requirements including fasting and avoiding certain medications.

Inclusion Criteria

Live full-time within a 60-mile radius of New York City.

Are able to swallow pills.

Were exposed to stressors related to their work in a health care setting during the COVID-19 pandemic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 to 7 weeks

Multiple visits (onsite and remote)

Treatment

Participants undergo MDMA-assisted therapy with three all-day dosing sessions and nine integration sessions

6 to 16 weeks

3 all-day dosing sessions, 9 integration sessions (some remote)

Treatment Termination

Participants complete primary outcome measures and meet with therapy team

2 to 4 weeks

1 visit (in-person)

Follow-up

Participants are contacted to repeat study measures to assess durability of effects

12 months

Contacted remotely

What Are the Treatments Tested in This Trial?

Interventions

• MDMA

Trial Overview

The trial is testing MDMA-Assisted Therapy's safety and effectiveness on healthcare workers with Post-Traumatic Stress from frontline work. It involves taking MDMA under controlled conditions alongside therapy sessions to see if it helps reduce stress disorder symptoms.

How Is the Trial Designed?

Group I: MDMA-assisted therapy Experimental Treatment 1 Intervention

Participants will receive 3-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions)

MDMA is already approved in United States for the following indications:

Approved in United States as MDMA for:

• Posttraumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

Nautilus Sanctuary

Lead Sponsor

Willa Hall

Lead Sponsor

Trials

1

Recruited

30+

Nautilus Psychiatric Services, PLLC

Collaborator

Citations

1.

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.

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.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0278584619301484

assisted psychotherapy for posttraumatic stress disorder: A ...

MDMA-assisted psychotherapy demonstrated a high rate of clinical response (RR = 3.47, 95% CI: 1.70, 7.06), remission (RR = 2.63, 95% CI: 1.37, 5.02), with a ...

4.

icer.org

icer.org/wp-content/uploads/2024/03/PTSD_Draft-Report_For-Publication_03262024.pdf

Draft Evidence Report

The Efficacy of MDMA (3,4-. Methylenedioxymethamphetamine) for Post-traumatic Stress Disorder in Humans: A Systematic Review and Meta ...

5.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0327778

MDMA-assisted therapy and current treatment options for ...

This systematic review suggests current treatments for PTSD are associated with heterogeneous evidence and the majority do not demonstrate sustained effects.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3122379/

the first randomized controlled pilot study

The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse ...