MDMA-Assisted CBCT for PTSD vs CBCT RCT

A Randomized Trial of MDMA-Assisted Cognitive-Behavioural Conjoint Therapy (CBCT) Versus CBCT in Dyads in Which One Member Has Posttraumatic Stress Disorder (PTSD)

MDMA-Assisted CBCT for PTSD vs CBCT RCT (NCT06044675) is a Phase 2 interventional studying Post Traumatic Stress Disorder, sponsored by Remedy. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery. CBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads. MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness. This randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Post Traumatic Stress Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Post Traumatic Stress Disorder subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria - Participant with PTSD 1. Participant with PTSD 2. Meet criteria for PTSD 3. Have a close other person who is able and willing to participate in this study 4. Are at least 18 years old 5. Are a resident of Ontario and live within the Greater Toronto Area (GTA) 6. Are in good physical health 7. Are proficient in speaking and reading English 8. Are willing to have all visits audio and video recorded 9. Are able to swallow pills 10. Agree to all study rules and commit to all medical and therapy visits 11. If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist 12. Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study 13. Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Therapy Session, and not to drive for at least 24 hours after taking MDMA 14. Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant 15. Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact 16. Agree to inform the researchers within 48 hours of any medical conditions and procedures 17. Agree to not participate in any other clinical trials during this study - Close Significant Other 1. Have a close other person who meets criteria for PTSD and is able and willing to participate in this study 2. Are at least 18 years old 3. Are a resident of Ontario and live within the Greater Toronto Area (GTA) 4. Are in good physical health 5. Are proficient in speaking and reading English 6. Are willing to have all visits audio and video recorded 7. Are able to swallow pills 8. Agree to all study rules and commit to all medical and therapy visits ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria * Participant with PTSD 1. Participant with PTSD 2. Meet criteria for PTSD 3. Have a close other person who is able and willing to participate in this study 4. Are at least 18 years old 5. Are a resident of Ontario and live within the Greater Toronto Area (GTA) 6. Are in good physical health 7. Are proficient in speaking and reading English 8. Are willing to have all visits audio and video recorded 9. Are able to swallow pills 10. Agree to all study rules and commit to all medical and therapy visits 11. If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist 12. Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study 13. Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Therapy Session, and not to drive for at least 24 hours after taking MDMA 14. Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant 15. Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact 16. Agree to inform the researchers within 48 hours of any medical conditions and procedures 17. Agree to not participate in any other clinical trials during this study * Close Significant Other 1. Have a close other person who meets criteria for PTSD and is able and willing to participate in this study 2. Are at least 18 years old 3. Are a resident of Ontario and live within the Greater Toronto Area (GTA) 4. Are in good physical health 5. Are proficient in speaking and reading English 6. Are willing to have all visits audio and video recorded 7. Are able to swallow pills 8. Agree to all study rules and commit to all medical and therapy visits 9. If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist 10. Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study 11. Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Therapy Session, and not to drive for at least 24 hours after taking MDMA 12. Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant 13. Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact 14. Agree to inform the researchers within 48 hours of any medical conditions and procedure 15. Agree to not participate in any other clinical trials during this study Exclusion Criteria * Participant with PTSD 1. Are pregnant or could become pregnant and not using birth control 2. Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder 3. Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm) 4. Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable 5. Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement 6. Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication 7. Have liver disease with symptoms 8. Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness) 9. Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather) 10. Weigh less than 48 kg 11. Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team) 12. Require ongoing therapy with a psychiatric medication 13. Have a current eating disorder with active purging 14. Have current major depressive disorder with psychotic features 15. Are a serious risk to others 16. Have recently received Electroconvulsive Therapy (ECT) 17. Have recently engaged in ketamine-assisted therapy or used ketamine 18. Have current substance use disorder with physiological dependence (not including caffeine or nicotine) 19. Have recently used "Ecstasy" (material represented as containing MDMA) 20. Are not able to give adequate informed consent 21. Are not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support as indicated by a time-limited clinical trial 22. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders * Close Significant Other 1. Meet criteria for PTSD 2. Are pregnant or could become pregnant and not using birth control 3. Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder 4. Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm) 5. Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable 6. Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement 7. Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication 8. Have liver disease with symptoms 9. Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness) 10. Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather) 11. Weigh less than 48 kg 12. Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team) 13. Require ongoing therapy with a psychiatric medication 14. Have a current eating disorder with active purging 15. Have current major depressive disorder with psychotic features 16. Are a serious risk to others 17. Have recently received Electroconvulsive Therapy (ECT) 18. Have recently engaged in ketamine-assisted therapy or used ketamine 19. Have current substance use disorder with physiological dependence (not including caffeine or nicotine) 20. Have recently used "Ecstasy" (material represented as containing MDMA) 21. Are not able to give adequate informed consent 22. Are not able to adhere to the requirements for procedures, attendance and timing of visits, and observe limits regarding study staff time and support as indicated by a time-limited clinical trial 23. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders

Treatments Being Tested

DRUG

MDMA assisted psychotherapy

This treatment combines MDMA with a well researched treatment for PTSD for dyads known as CBCT. Dyads will undergo a 7-week course of psychotherapy with two doses of MDMA will be used as an adjunct to psychotherapy.

BEHAVIORAL

Psychotherapy

A manualized treatment for PTSD for dyads wherein one person has symptoms of PTSD. This intervention is 7-week course of psychotherapy that is designed to simultaneously improve PTSD symptoms and relationship functioning through education and skill training.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Remedy Institute

Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06044675), the sponsor (Remedy), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06044675 clinical trial studying?

Who can participate in NCT06044675?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06044675?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06044675. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06044675. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.