What is the mechanism of action of this treatment?

MDMA-assisted therapy for PTSD increases the release of serotonin, dopamine, and norepinephrine, enhancing mood and emotional processing, which helps reduce avoidance behaviors and improves tolerance for recalling painful memories. This is crucial for PTSD patients as it directly targets the emotional and cognitive disruptions caused by trauma. Other treatments like SSRIs and SNRIs also increase serotonin levels to improve mood and reduce anxiety, while Cognitive Processing Therapy (CPT) focuses on altering negative thought patterns related to trauma. Understanding these mechanisms is important as they offer a multifaceted approach to managing PTSD symptoms.

What side effects are associated with this type of intervention?

Common treatments for PTSD, such as SSRIs and SNRIs, often cause side effects like nausea, insomnia, sexual dysfunction, and weight gain. Trauma-focused psychotherapies generally have fewer physical side effects but can cause emotional distress during sessions. MDMA-assisted therapy, which increases the release of serotonin, dopamine, and norepinephrine, can lead to side effects such as increased heart rate, blood pressure, anxiety, and potential neurotoxicity with long-term use. It may also cause transient psychological effects like euphoria, sensory changes, and, in some cases, negative psychological symptoms.

What prior FDA approvals exist?

The FDA has approved selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine for the treatment of PTSD. These medications work by increasing the levels of serotonin in the brain, which helps improve mood and emotional processing. While MDMA-assisted therapy, which also increases the release of serotonin, dopamine, and norepinephrine, is still under investigation and not yet FDA-approved, it shows promise in clinical trials for reducing PTSD symptoms.

What other types of research exist?

Promising novel alternatives to MDMA-assisted therapy for PTSD include psilocybin-assisted psychotherapy, which has shown efficacy in treating psychiatric and existential distress, and combined pharmacotherapy and psychological therapies, such as prolonged exposure therapy with paroxetine. These alternatives offer different mechanisms of action and have demonstrated potential benefits in clinical settings.

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MDMA-Assisted Therapy vs Cognitive Processing Therapy for PTSD

Phase 2

Waitlist Available

Led By Trisha Suppes, MD, PhD

Research Sponsored by Patricia Suppes

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to approximately 4 months post-baseline

Awards & highlights

Summary

This trial is testing a new treatment that uses MDMA along with therapy to help veterans with PTSD who haven't improved with other treatments. MDMA makes therapy sessions more effective by helping patients feel less fearful and more open. The study will compare this new method to another common PTSD therapy to see which works better. MDMA has been shown in several studies to enhance the effectiveness of psychotherapy for PTSD by reducing fear and increasing openness during therapy sessions.

Who is the study for?

This trial is for U.S. Military Veterans with severe PTSD lasting at least 6 months, who are fluent in English and weigh at least 48 kg. Participants must not be pregnant or breastfeeding, have a support person for post-session evenings, and can't have certain mental health conditions, unstable medical illnesses, serious heart issues, high suicide risk, or recent substance abuse.

What is being tested?

The study compares MDMA-assisted therapy with Cognitive Processing Therapy (CPT) to see which is better for treating PTSD in veterans. It will also look into how feasible it is to use this treatment within the VA system and its economic impact.

What are the potential side effects?

MDMA may cause anxiety, changes in mood or perception, increased heart rate and blood pressure; however specific side effects related to the trial's interventions will be monitored closely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to approximately 4 months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to approximately 4 months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to approximately 4 months post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score

Secondary study objectives

Change in Quality of Life Enjoyment and Satisfaction Questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Group I: MDMA-assisted therapy (MDMA-AT)Experimental Treatment2 Interventions

This arm consists of three, 90-minute, non-drug Preparatory Sessions and a \~12-week Treatment Period comprised of three Experimental Sessions with MDMA (\~ 8 hours), each followed by three 90-minute, non-drug Integration Sessions. Participants will receive 60mg MDMA HCl for first Experimental Session and 60mg or 120mg MDMA HCl for following Experimental Sessions. During each Experimental Session, participants will have the option of receiving a supplemental dose of 40mg or 60mg MDMA HCl 1.5-2 hours after the initial dose. Participants will have the option to crossover to the CPT arm 6 months after all study visits are completed.

Group II: Cognitive processing therapyExperimental Treatment1 Intervention

This arm consists of one, 60-minute, introductory meeting with the therapist followed by a \~12-week Treatment Period comprised of 12 1-hour CPT sessions with three optional additional sessions, each approximately one week apart. Participants will have the option to crossover to the MDMA-AT arm 6 months after all study visits are completed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MDMA

2023

Completed Phase 2

~420

Cognitive Processing Therapy

2016

N/A

~3770

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

MDMA-assisted therapy for PTSD increases the release of serotonin, dopamine, and norepinephrine, enhancing mood and emotional processing, which helps reduce avoidance behaviors and improves tolerance for recalling painful memories. This is crucial for PTSD patients as it directly targets the emotional and cognitive disruptions caused by trauma. Other treatments like SSRIs and SNRIs also increase serotonin levels to improve mood and reduce anxiety, while Cognitive Processing Therapy (CPT) focuses on altering negative thought patterns related to trauma. Understanding these mechanisms is important as they offer a multifaceted approach to managing PTSD symptoms.

Posttraumatic Growth After MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder.

Find a Location

Who is running the clinical trial?

Steven & Alexandra Cohen FoundationUNKNOWN

7 Previous Clinical Trials

228 Total Patients Enrolled

VA Palo Alto Health Care SystemFED

92 Previous Clinical Trials

58,129 Total Patients Enrolled

Patricia SuppesLead Sponsor

Media Library

Cognitive Processing Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05837845 — Phase 2

Post-Traumatic Stress Disorder Research Study Groups: Cognitive processing therapy, MDMA-assisted therapy (MDMA-AT)

Post-Traumatic Stress Disorder Clinical Trial 2023: Cognitive Processing Therapy Highlights & Side Effects. Trial Name: NCT05837845 — Phase 2

Cognitive Processing Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05837845 — Phase 2

~20 spots leftby May 2025

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