What side effects are associated with this type of intervention?

Common treatments for PTSD, such as SSRIs (e.g., sertraline) and SNRIs (e.g., venlafaxine), often cause side effects like nausea, insomnia, sexual dysfunction, and increased anxiety. Trauma-focused psychotherapies, including exposure therapy, may initially increase distress as patients confront traumatic memories. MDMA-assisted therapy, which enhances emotional processing and reduces fear responses, can cause acute side effects such as increased heart rate, blood pressure, anxiety, and in some cases, nausea and jaw clenching. Long-term side effects of MDMA are still being studied, but concerns include potential neurotoxicity and cognitive deficits.

What prior FDA approvals exist?

The FDA has approved selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine for the treatment of Post-Traumatic Stress Disorder (PTSD). These medications help reduce PTSD symptoms by modulating serotonin levels in the brain, which can enhance emotional processing and reduce fear responses. Additionally, the FDA has agreed to an expanded access program for MDMA-assisted psychotherapy for PTSD, recognizing its potential in enhancing emotional processing and reducing fear responses, similar to the effects being studied in ongoing trials.

What other types of research exist?

Promising novel alternatives to MDMA-assisted therapy for PTSD include: <ol> <li>Prazosin: An alpha-adrenergic receptor blocker that has shown efficacy in reducing PTSD symptoms, nightmares, and improving sleep quality in some clinical trials.</li> <li></li> </ol> Second-Generation Antipsychotics (SGAs): Medications like quetiapine and risperidone have shown some efficacy in reducing PTSD symptoms, particularly in patients with prominent psychotic symptoms. 3. Cognitive-Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP): This remains a recommended treatment, often combined with SSRIs for enhanced efficacy. 4. Cannabinoids: Although evidence is modest, some patients have shown preference for cannabinoids in managing symptoms. 5. Equine-Assisted Therapy and Service Dogs: These therapies have shown promise in open trials and studies, particularly among military veterans.

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Psychedelic

MDMA-Assisted Therapy for PTSD

Phase 2

Waitlist Available

Led By Stephen Marder, MD

Research Sponsored by Stephen Robert Marder

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 visit 17 (approximately 14 weeks after enrollment)

Awards & highlights

Summary

This trial is testing two treatments for adults with moderate to severe PTSD. One treatment uses MDMA to help patients feel more comfortable during therapy, and the other uses a small dose of d-amphetamine to help them stay focused. The goal is to see if these treatments can reduce PTSD symptoms. MDMA has recently been shown as a novel therapeutic agent with promising results in the treatment of PTSD.

Who is the study for?

This trial is for veterans in the Greater Los Angeles area who have moderate to severe PTSD. Participants must be fluent in English, able to use effective contraception if applicable, and willing to have therapy sessions recorded. They should not be abusing drugs or involved in other clinical studies.

What is being tested?

The study compares MDMA-assisted therapy with low dose d-amphetamine-assisted therapy for PTSD symptoms. It's a phase II trial where participants are randomly assigned to one of the two treatments without knowing which one they're receiving.

What are the potential side effects?

Possible side effects may include anxiety, changes in mood, sleep disturbances, appetite changes, physical sensations like nausea or chills, and potential psychological distress related to confronting traumatic memories during therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 17 (approximately 14 weeks after enrollment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 17 (approximately 14 weeks after enrollment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 17 (approximately 14 weeks after enrollment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Compare changes in PTSD symptom severity in the MDMA vs active control group.

Secondary study objectives

Compare changes in clinician-rated functional impairment in the MDMA vs active control group.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MDMA-Assisted TherapyExperimental Treatment2 Interventions

Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.

Group II: Low Dose D-Amphetamine Assisted TherapyActive Control2 Interventions

Participants will receive a flexible divided dose plus therapy at Experimental Sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapy

2014

Completed Phase 3

~990

3,4-methylenedioxymethamphetamine

2021

Completed Phase 1

~190

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

Common treatments for Post-Traumatic Stress Disorder (PTSD) include MDMA-assisted therapy, selective serotonin reuptake inhibitors (SSRIs), and trauma-focused cognitive-behavioral therapy (CBT). MDMA-assisted therapy enhances emotional processing and reduces fear responses by strengthening therapeutic alliances and improving tolerance for recalling and processing painful memories. SSRIs work by increasing serotonin levels in the brain, which helps to regulate mood and reduce anxiety. Trauma-focused CBT, including exposure therapy, helps patients confront and process traumatic memories in a controlled environment, reducing the power of these memories over time. These treatments are crucial for PTSD patients as they address the core symptoms of the disorder, such as intrusive memories, avoidance behaviors, and heightened arousal, ultimately improving their quality of life.

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

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Who is running the clinical trial?

Stephen Robert MarderLead Sponsor

Stephen Marder, MDPrincipal InvestigatorVA Greater Los Angeles Healthcare System

3 Previous Clinical Trials

356 Total Patients Enrolled

Stephanie L Taylor, PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System

Media Library

3,4-methylenedioxymethamphetamine (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05790239 — Phase 2

Post-Traumatic Stress Disorder Research Study Groups: MDMA-Assisted Therapy, Low Dose D-Amphetamine Assisted Therapy

Post-Traumatic Stress Disorder Clinical Trial 2023: 3,4-methylenedioxymethamphetamine Highlights & Side Effects. Trial Name: NCT05790239 — Phase 2

3,4-methylenedioxymethamphetamine (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05790239 — Phase 2

~15 spots leftby May 2025

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