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Psychedelic

MDMA-Assisted Therapy for PTSD

Phase 2
Waitlist Available
Led By Stephanie L Taylor, PhD
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 compares two treatments for PTSD: MDMA-assisted & d-amphetamine-assisted therapy. It tests safety & effectiveness of the treatments in adults with moderate-severe 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare changes in PTSD symptom severity in the MDMA vs active control group.
Secondary outcome measures
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
~170

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.

Find a Location

Who is running the clinical trial?

Stephen Robert MarderLead Sponsor
Stephanie L Taylor, PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System
Stephen Marder, MDPrincipal InvestigatorVA Greater Los Angeles Healthcare System
3 Previous Clinical Trials
356 Total Patients Enrolled

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
~19 spots leftby May 2025