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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

Study 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

Find a Location

Who is running the clinical trial?

Steven & Alexandra Cohen FoundationUNKNOWN
6 Previous Clinical Trials
194 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
87 Previous Clinical Trials
56,833 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any fresh participants able to join this trial?

"According to clinicaltrials.gov, this medical trial has concluded its recruitment process and is not actively searching for candidates at the moment. Initially posted on September 1st 2023, with a final edit made on April 20th of that same year; despite this study's closure there are still 402 other trials in search of participants currently underway."

Answered by AI

Is the use of MDMA in conjunction with therapy sanctioned by the FDA?

"Despite being in the relatively early stages of clinical trials, there is sufficient evidence to assign a score of 2 for MDMA-assisted therapy's safety. At this point, data only support its safety rather than any efficacy yet."

Answered by AI

Who else is applying?

What site did they apply to?
VA Palo Alto Health Care System / Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
MDMA-assisted Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
Patricia Suppes 2024. "MDMA-assisted Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05837845.
~20 spots leftby May 2025
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