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MDMA-Assisted Therapy for PTSD

Phase 2
Waitlist Available
Led By Alison Bruni, MD
Research Sponsored by Remedy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study
Are at least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (enrolment) to endpoint (6 month follow up)
Awards & highlights

Study Summary

This trial is studying whether a combination of the drug MDMA and cognitive processing therapy is safe and helpful for people with post-traumatic stress disorder.

Who is the study for?
This trial is for Ontario residents within 200km of the study site, aged 18+, with PTSD. Participants must be in good health, able to swallow pills, and proficient in English. They should agree to video recording of sessions, not drive post-MDMA use, avoid pregnancy during the study if applicable, and stop other medications or trials. A supportive contact is required.Check my eligibility
What is being tested?
The trial tests MDMA-assisted Cognitive Processing Therapy (CPT) for PTSD treatment over two months. It involves CPT sessions integrated with two doses of MDMA as an adjunct therapy. The focus is on how MDMA may enhance CPT by reducing fear and increasing emotional engagement.See study design
What are the potential side effects?
MDMA can cause side effects like anxiety, headache, fatigue, muscle tension or cramps; it might also affect mood after use (e.g., depression), induce nausea or decrease appetite during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stop taking all my current medications, including herbal supplements, for the study.
Select...
I am 18 years old or older.
Select...
I agree to overnight stays for MDMA therapy sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (enrolment) to endpoint (6 month follow up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (enrolment) to endpoint (6 month follow up) 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 From Baseline to 1 Month Follow up in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
Change From Baseline to 3 Month Follow up in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
Change From Baseline to Midpoint (visit 6) in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
+1 more
Secondary outcome measures
Change From Baseline to 1 Month Follow up in PTSD Symptoms Checklist
Change From Baseline to 1 Month Follow up in The Patient Health Questionnaire-9 Depression Symptoms
Change From Baseline to 3 Month Follow up in PTSD Symptoms Checklist
+5 more

Side effects data

From 2018 Phase 1 & 2 trial • 12 Patients • NCT02876172
33%
Anxiety
17%
Nasal congestion
17%
Rash
17%
Dyspnoea
17%
Visual Impairment
17%
Vomiting
17%
Upper respiratory tract infection
17%
Arthropod bite
17%
Disturbance in attention
17%
Paresthesia
17%
Oropharyngeal pain
17%
Pruritis
17%
Dizziness
17%
Insomnia
17%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
CSO Patients at 6-month Follow-up
PTSD Patients at 6-month Follow-up
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)

Trial Design

1Treatment groups
Experimental Treatment
Group I: MDMA assisted psychotherapyExperimental Treatment1 Intervention
Participants will undergo a 2-month course of CPT psychotherapy for PTSD with two sessions that integrate MDMA-assisted psychotherapy. MDMA will be administered ini two separate sessions and integrated into the psychotherapy protocol. The two doses of MDMA during this study will be used as an adjunct to psychotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MDMA
2001
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

Lykos TherapeuticsOTHER
41 Previous Clinical Trials
1,629 Total Patients Enrolled
Toronto Metropolitan UniversityOTHER
84 Previous Clinical Trials
10,957 Total Patients Enrolled
Multidisciplinary Association for Psychedelic StudiesOTHER
39 Previous Clinical Trials
1,603 Total Patients Enrolled

Media Library

MDMA-Assisted Psychotherapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05067244 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: MDMA assisted psychotherapy
Post-Traumatic Stress Disorder Clinical Trial 2023: MDMA-Assisted Psychotherapy Highlights & Side Effects. Trial Name: NCT05067244 — Phase 2
MDMA-Assisted Psychotherapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05067244 — Phase 2

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Pennsylvania
New York
California
How old are they?
18 - 65
What site did they apply to?
Remedy Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)
2021. "A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067244.
All > Post Traumatic Stress Disorder
~0 spots leftby Jun 2024
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