MDMA + Psilocybin for PTSD

(PAM-VET Trial)

Overseen By Chloe Ford, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Antidepressants, MAOIs, Bupropion, others

Disqualifiers: Schizophrenia, Bipolar, Alcohol use, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining MDMA (a psychoactive drug) and psilocybin (a psychedelic compound) is safe and effective for treating PTSD in military Veterans. Participants will first receive MDMA, followed by psilocybin, to assess their potential benefits in managing PTSD symptoms. Veterans with PTSD lasting at least six months who have not used these substances in large doses before may be suitable candidates. Visit the provided website to learn more about joining.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.

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

Yes, you may need to stop taking certain medications. The trial requires stopping medications that affect serotonin or liver enzymes, and you must refrain from using nonprescription medications, supplements, or herbal supplements for one week before each drug session, unless approved by the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using MDMA and psilocybin together may help treat PTSD. Studies have found that therapy with MDMA can lessen PTSD symptoms without causing serious side effects. For example, no deaths or major problems have been linked to MDMA treatment for PTSD.

Early results also suggest that psilocybin, when combined with therapy, can help reduce PTSD symptoms. Both MDMA and psilocybin affect brain chemicals related to mood and stress, such as serotonin. This trial is in its early stages, so researchers are still testing the combination for safety. However, past studies indicate that adults generally tolerate the treatment well.

Before joining a trial, it's important to know that early-phase studies focus on safety. They are designed to monitor any side effects and observe how participants react to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using MDMA combined with psilocybin for PTSD because this approach leverages two powerful psychoactive compounds that may work differently from traditional treatments like SSRIs or cognitive-behavioral therapy. MDMA is thought to enhance emotional processing and openness, potentially allowing for more profound therapeutic breakthroughs. Meanwhile, psilocybin may facilitate neuroplasticity and help to reset negative thought patterns. This combination might provide rapid and transformative results, offering hope for those who haven't found relief with existing therapies.

What evidence suggests that this trial's treatments could be effective for PTSD?

This trial will compare two different approaches using MDMA and psilocybin for PTSD. Studies have shown that MDMA can reduce PTSD symptoms by increasing brain chemicals like dopamine and serotonin, which influence mood and stress. MDMA-assisted therapy has proven particularly effective for individuals with moderate to severe PTSD. Psilocybin, another psychedelic, may help by altering brain activity and encouraging emotional release. Although researchers are still studying the combination of MDMA and psilocybin, early results suggest it could be a promising treatment for PTSD. These therapies aim to provide relief by helping patients process traumatic memories in a supportive environment. ^{1 2 3 4 5}

Who Is on the Research Team?

Brandon Weiss, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Military Veterans aged 21+ with confirmed PTSD lasting over 6 months, a CAPS-5 score of >=28, and stable psychotherapy. Participants must be medically stable, not at high risk for suicide, able to swallow pills, weigh between 40kg-120kg, have at least high school education or equivalent, and agree to drug restrictions. Exclusions include certain medical conditions or histories; recent suicidal ideation; unstable medication doses; illicit drug/alcohol use; pregnancy/nursing.

Inclusion Criteria

Must be medically stable as determined by screening for medical problems

I have been in stable psychotherapy for at least 2 months.

Must be judged by study team clinicians to be at low acute risk for suicidality

Exclusion Criteria

Specific medical history exclusions

Specific medical history exclusions

Specific medical history exclusions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single experimental dose of co-administered MDMA and psilocybin, followed by a second single-blind dosing session approximately 1.5 months later

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of PTSD symptoms and adverse events

33 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MDMA
• Psilocybin

Trial Overview The trial is testing the safety and effectiveness of MDMA combined with psilocybin in treating PTSD in military veterans. The study involves administering these substances under controlled conditions to evaluate their therapeutic potential compared to current treatment standards.

How Is the Trial Designed?

Group I: Experimental MDMA + psilocybin (exact dosage not disclosed) Experimental Treatment 2 Interventions

MDMA will be given initially, followed by psilocybin 30 minutes later.

Group II: Comparator MDMA + psilocybin (exact dosage not disclosed) Active Control 2 Interventions

MDMA will be given initially, followed by psilocybin 30 minutes later.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Gracias Family Foundation

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06989957?cond=Post%20Traumatic%20Stress%20Disorder&intr=%22Psilocybin%22&viewType=Table&rank=3

Study Details | NCT06989957 | Psilocybin and ... The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of ...

4. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp

Psychedelic-Assisted Therapy for PTSD MDMA-AT is currently being investigated for its potential to treat eating disorders (11), anxiety (12), alcohol and substance abuse (13), and PTSD (14). The ...

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

The efficacy and safety of MDMA-assisted psychotherapy ... The results revealed that MDMA-assisted psychotherapy effectively reduced the change from baseline score in the Clinician-Administered PTSD Scale in patients ...