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MDMA-Assisted Psychotherapy for PTSD

Phase 2
Recruiting
Led By Paul Uy, MD
Research Sponsored by Remedy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are able to swallow pills
Are at least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month follow-up
Awards & highlights

Study Summary

This trial aims to study the benefits of combining MDMA-assisted Cognitive-Behavioral Conjoint Therapy with the treatment of Post-Traumatic Stress Disorder (PTSD). The study will look at the safety, feasibility, acceptability, and effectiveness of the combination.

Who is the study for?
This trial is for adults with PTSD in the Greater Toronto Area who are willing to stop taking certain medications and agree to study rules. Participants must be healthy, able to swallow pills, proficient in English, and have a supportive person willing to join the study. Pregnant individuals or those at risk of becoming pregnant without contraception are excluded.Check my eligibility
What is being tested?
The trial tests MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) against CBCT alone for PTSD treatment. It explores whether MDMA's effects on empathy and openness can enhance CBCT's impact on symptoms and relationship satisfaction over a 7-week course with two full-day sessions.See study design
What are the potential side effects?
MDMA may cause side effects like anxiety, changes in mood, confusion, headaches, increased heart rate and blood pressure issues. Long-term risks include potential substance use disorder related to MDMA.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills.
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I am 18 years old or older.
Select...
I am willing to stop taking all my current medications, including psychiatric and herbal supplements, for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-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
Clinician Administered PTSD Scale (CAPS-5)
Feasibility of Intervention Measure (FIM)
Intervention Appropriateness Measures (IAM)
+2 more
Secondary outcome measures
Couple Satisfaction Index (CSI)
Patient Health Questionnaire-9 (PHQ-9)
Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5)
+1 more
Other outcome measures
Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test-Revised (CUDIT-R), and Drug Use Disorders Identification Test (DUDIT)
Brief Experiential Avoidance Questionnaire (BEAQ)
Brief Posttraumatic Cognitions Inventory (PTCI-9)
+10 more

Side effects data

From 2020 Phase 3 trial • 100 Patients • NCT03537014
72%
Headache
61%
Muscle Tightness
52%
Decreased Appetite
46%
Suicidal Ideation
43%
Insomnia
33%
Anxiety
30%
Fatigue
30%
Nausea
26%
Viral Upper Respiratory Tract Infection
22%
Hyperhidrosis
20%
Feeling Cold
20%
Dizziness
15%
Nightmare
15%
Asthenia
15%
Mydriasis
15%
Restlnessness
13%
Dizziness Postural
13%
Nystagmus
13%
Tremor
13%
Bruxism
13%
Abdominal Discomfort
11%
Feeling Jittery
11%
Dry Mouth
11%
Back Pain
11%
Depressed Mood
11%
Upper Respiratory Tract Infection
11%
Blood Pressure Increased
11%
Paraesthesia
11%
Abdominal Pain Upper
9%
Vomiting
9%
Feeling Hot
9%
Musculoskeletal Pain
9%
Palpitations
9%
Non-Cardiac Chest Pain
9%
Vision Blurred
9%
Depression
9%
Disturbance in Attention
9%
Stress
9%
Intrusive Thoughts
9%
Pain
9%
Pollakiuria
9%
Feeling of Body Temperature Change
9%
Arthralgia
9%
Temperature Intolerence
7%
Muscle Spasms
7%
Chills
7%
Muscle Twitching
7%
Flashback
7%
Pain in Jaw
7%
Anger
7%
Micturition Urgency
7%
Nervousness
7%
Feeling Abnormal
7%
Hypoaesthesia
7%
Somnolence
7%
Substance Use
7%
Ear Pain
7%
Myalgia
7%
Vertigo
7%
Influenza
7%
Dysmenorrhoea
7%
Pyrexia
4%
Influenza Like Illness
4%
Diarrhea
4%
Emotional Disorder
4%
Irritability
4%
Neck Pain
4%
Agitation
4%
Oropharyngeal Pain
4%
Emotional Distress
4%
Dissociation
4%
Panic Attack
2%
Intentional Self-Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
MDMA-assisted Therapy
Placebo With Therapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MDMA-Assisted CBCT ConditionExperimental Treatment1 Intervention
Dyads will undergo a 7-week course of CBCT psychotherapy for PTSD with two sessions that integrate MDMA-assisted psychotherapy. MDMA will be administered in 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.
Group II: CBCT-Only ConditionActive Control1 Intervention
Dyads will undergo a 7-week course of CBCT psychotherapy for PTSD. Dyads who have undergone the CBCT-Only condition will have the option to do a crossover and have the two MDMA sessions after follow-up.

Find a Location

Who is running the clinical trial?

Remedy InstituteOTHER
RemedyLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Paul Uy, MDPrincipal InvestigatorRemedy Institute

Frequently Asked Questions

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

Does the research protocol permit participants under fifty years of age?

"The parameters for enrolment stipulate that only those aged between 18 and 80 can take part in the experiment."

Answered by AI

Has the FDA sanctioned MDMA-Assisted Cognitive Behavioral Conjoint Therapy?

"The safety of MDMA-Assisted CBCT Condition has been analyzed by our experts at Power and given a score of 2. This is because, as a Phase 2 trial there are certain safeguards in place, however no efficacy data exists yet to support it."

Answered by AI

Which demographic is eligible to participate in this scientific experiment?

"This clinical trial has 60 openings for individuals suffering from post-traumatic stress disorder who range in age between 18 and 80. To be eligible, a patient must: meet the established criteria of PTSD diagnosis; swallow pills normally; have no major physical health issues; and already possess an official PTSD classification."

Answered by AI

Are applicants currently being accepted for this trial?

"As per data on clinicaltrials.gov, this trial is not presently open for recruitment. Initially posted on October 15th 2023 and most recently modified September 13th 2023, the study does not currently need patients; however there are 408 other trials actively recruiting at present."

Answered by AI

What objectives does this experiment aim to attain?

"The objective of this three-month medical investigation is to assess the safety of a particular intervention. Additionally, during the trial period, secondary outcomes such as Quality of Relationships Inventory (QRI), Couple Satisfaction Index (CSI) and Patient Health Questionnaire-9 (PHQ-9) will be surveyed in order to measure supportive/conflictual aspects within non-intimate relationships, couple satisfaction levels and severity of depressive symptoms respectively."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
MDMA-Assisted CBCT for PTSD vs CBCT RCT
2023. "MDMA-Assisted CBCT for PTSD vs CBCT RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06044675.
~40 spots leftby Dec 2025
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