MDMA-Assisted Therapy for Post-Traumatic Stress Disorder

(DosOp Trial)

Recruiting at 1 trial location

Overseen By Amy Lehrner, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bronx VA Medical Center

Must not be taking: Psychiatric medications

Disqualifiers: Hypertension, Liver disease, Drug abuse, 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

Compensation: Varies

Number of Visits: 1

Duration: 3-5 weeks per cycle, up to 25 weeks total

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal number of MDMA-Assisted Therapy sessions for U.S. veterans with PTSD, a condition causing severe anxiety after traumatic events. Participants may receive up to five therapy cycles, each including a session with MDMA (Midomafetamine) and three follow-up therapy sessions. The study is open to U.S. veterans who can swallow pills, have PTSD, and are willing to engage in all study activities, including therapy sessions and recordings. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial requires participants to safely taper off certain psychiatric medications. If you're taking any psychiatric drugs, you may need to stop them before joining the study.

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 its safety and effectiveness in treating PTSD. In earlier studies, no deaths or serious treatment-related side effects occurred, suggesting that the therapy is generally well-tolerated.

However, some participants experienced mental side effects like restlessness and trouble sleeping. These effects are not uncommon and can often be managed. Overall, the data indicate that MDMA-assisted therapy can reduce PTSD symptoms without major safety concerns.

Since this treatment is being tested in Phase 2 trials, researchers are still carefully checking its safety in a larger group of people. This phase is crucial for understanding how well people handle the treatment and what side effects might occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

MDMA-Assisted Therapy is unique because it combines the psychoactive effects of MDMA with psychotherapy to target Post-Traumatic Stress Disorder (PTSD) in a different way than traditional treatments like SSRIs or cognitive-behavioral therapy. Researchers are excited about this approach because MDMA can potentially enhance the therapeutic process by fostering openness, reducing fear, and increasing emotional engagement during therapy sessions. Unlike many traditional treatments that require long-term use, MDMA-Assisted Therapy could offer relief with just a few sessions, providing a faster and potentially more effective path to healing for those with PTSD.

What evidence suggests that MDMA-Assisted Therapy might be an effective treatment for PTSD?

Research has shown that MDMA-Assisted Therapy can effectively treat PTSD. In one study, 86.5% of participants experienced significant improvement in their PTSD symptoms 18 weeks after starting the therapy. Another study found that 80% of patients had their symptoms disappear for three years after just two or three sessions. These findings suggest that MDMA-Assisted Therapy, which participants in this trial will receive, could provide lasting relief for many people with PTSD. ^{2 4 6 7 8}

Who Is on the Research Team?

Amy Lehrner, PhD

Principal Investigator

James J. Peters VA Medical Center

Rachel Yehuda, PhD

Principal Investigator

James J. Peters VA Medical Center

Are You a Good Fit for This Trial?

This trial is for U.S. veterans with PTSD who can consent, swallow pills, and agree to recorded study visits. Participants need a contact person for emergencies, must not be in other trials, commit to the therapy and study procedures. If they can become pregnant, they must test negative for pregnancy and use contraception.

Inclusion Criteria

I can sign and understand the consent form.

I can swallow pills.

I agree to have all study visits and sessions recorded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment

Enrollment and medication tapering period (if needed) followed by psychological assessment and Enrollment Confirmation, collection of biomarker blood samples

2-4 weeks

Treatment

3 Preparatory sessions; one to five Experimental Sessions, each followed by 3 non-drug Integrative Sessions and a follow-up visit with study therapists

3-5 weeks per cycle, up to 25 weeks total

Post-treatment

Psychological Evaluation, biomarker blood samples, study termination visit

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MDMA-Assisted Therapy
• Midomafetamine

Trial Overview The trial is testing how many cycles of MDMA-Assisted Therapy (one MDMA session plus three integration sessions) are optimal for treating PTSD in veterans. Each participant may undergo up to five treatment cycles to determine the best number.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 2 Interventions

Open label, within-subjects treatment arm. Participants receive 120mg + optional 60mg supplement. There will be from one to five dosing sessions that occur three to five weeks apart. Each dosing session is followed by three integration psychotherapy sessions.

Who Is Running the Clinical Trial?

Bronx VA Medical Center

Lead Sponsor

Trials

22

Recruited

1,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10316220/

A Review of MDMA-Assisted Therapy for Posttraumatic Stress ... This study included 20 patients with treatment-refractory PTSD symptoms and demonstrated an 80% remission rate sustained at 3 years after two or three sessions.

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

MDMA-assisted therapy for moderate to severe PTSD In the MDMA-AT group, 45 of 52 (86.5%) participants were responders with a clinically meaningful improvement at 18 weeks after baseline, defined ...

3. 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- ...

4. icer.org icer.org/wp-content/uploads/2023/11/PTSD_Revised-Report_For-Publication_05142024.pdf

Midomafetamine-Assisted Psychotherapy for Post- ... Additionally, we evaluated available evidence on the comparative effectiveness of MDMA-AP versus other short-term trauma-focused psychotherapies ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00090064

NCT00090064 | MDMA-Assisted Psychotherapy in People ... The study will test whether MDMA-assisted therapy can be safely given to participants. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group ...

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 ... For example, MDMA-assisted therapy can reduce PTSD symptoms and functional impairment in a diverse population with moderate to severe PTSD (Yang et al., 2024).

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

Midomafetamine-Assisted Psychotherapy for Post- ... Additionally, MDMA-AP led to increased occurrence of psychiatric safety events, including restlessness and insomnia. If these results are ...