MDMA Therapy for Post-Traumatic Stress Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether MDMA, a drug known for its effects on mood and emotions, can help veterans with PTSD improve their symptoms. Researchers aim to determine if MDMA combined with therapy is more effective in a one-on-one setting or a group setting. The study seeks veterans diagnosed with PTSD who can take pills and complete study tasks independently. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that MDMA therapy is likely to be safe for humans?
Research has shown that MDMA-assisted therapy is generally safe for people with PTSD (Post-Traumatic Stress Disorder). Studies have found no reports of deaths or severe side effects when MDMA is used with therapy. In a controlled study, MDMA did not cause addiction, suicidal thoughts, or serious heart problems.
Another study found that MDMA can be safely given to PTSD patients and may help those who haven't improved with other treatments. Overall, evidence suggests that MDMA is well-tolerated, meaning most people do not experience serious side effects.12345Why do researchers think this study treatment might be promising for PTSD?
Unlike traditional treatments for PTSD, which often include antidepressants and therapy, MDMA therapy offers a unique approach by using MDMA, a psychoactive compound, to potentially enhance therapeutic outcomes. Researchers are excited because MDMA has the potential to facilitate emotional processing and increase feelings of trust and empathy, which can be particularly beneficial in a therapeutic setting. This approach may allow patients to work through traumatic memories more effectively and with less distress compared to conventional methods.
What evidence suggests that MDMA might be an effective treatment for PTSD?
Research has shown that therapy using MDMA can help treat PTSD (Post-Traumatic Stress Disorder). Studies found that 67% to 71% of participants who received MDMA with therapy experienced a significant reduction in PTSD symptoms. These benefits persisted for at least a year after treatment. In this trial, participants will receive MDMA in either individual or group therapy sessions. Positive outcomes have been observed in both one-on-one and group therapy settings with MDMA. This therapy not only eases symptoms but also improves overall functioning for people with PTSD.23678
Who Is on the Research Team?
Manish Agarwal
Principal Investigator
Sunstone Medical, PC
Are You a Good Fit for This Trial?
This trial is for veterans aged 18 or older who have PTSD, can speak and read English, swallow pills, and attend all study visits. People with certain mental health disorders, heart problems, high suicide risk, pregnancy (or not using birth control), or trouble taking oral meds cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MDMA
Trial Overview
The study tests the safety and effectiveness of MDMA-assisted therapy in veterans with PTSD. Participants receive a fixed dose of MDMA during therapy sessions either individually or in groups. The trial is open-label and conducted at one center.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunstone Medical
Lead Sponsor
Citations
The Efficacy of MDMA (3,4-Methylenedioxymethamphetamine ...
PTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Mithoefer et al ...
Efficacy of 3,4-methylenedioxymethamphetamine (MDMA)- ...
Evidence from randomised controlled trials (RCTs) suggests that MDMA-AT, when combined with psychotherapy, reduces PTSD symptoms, with 67 %–71 % of participants ...
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 ...
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 ...
Midomafetamine-Assisted Psychotherapy for Post- ...
Additionally, we evaluated available evidence on the comparative effectiveness of MDMA-AP versus other short-term trauma-focused psychotherapies ...
the first randomized controlled pilot study - PMC
MDMA-assisted psychotherapy can be administered to posttraumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory ...
ICER PTSD Draft Report 2024
The Efficacy of MDMA (3,4-. Methylenedioxymethamphetamine) for Post-traumatic Stress Disorder in Humans: A Systematic Review and Meta ...
A Review of MDMA-Assisted Therapy for Posttraumatic Stress ...
MDMA-assisted therapy for PTSD shows significant promise for rapid and sustained reduction in PTSD symptoms, improvement in functioning and disability status.
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