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MDMA-Assisted Therapy vs Cognitive Processing Therapy for PTSD

Phase 2
Waitlist Available
Led By Shannon Wiltsey Stirman, 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 will compare MDMA-assisted therapy to Cognitive Processing Therapy (CPT), a VA PTSD treatment, to assess its potential use in the VA system.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score
Secondary outcome measures
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
2001
Completed Phase 2
~390
Cognitive Processing Therapy
2016
N/A
~3400

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
223 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
88 Previous Clinical Trials
56,873 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