MDMA-assisted therapy for PTSD and relationship improvement

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

This study is testing whether therapy that includes MDMA can help couples with PTSD feel better and improve their relationship compared to regular therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Remedy (Industry-sponsored)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06044675 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) compared to standard CBCT for treating Post-Traumatic Stress Disorder (PTSD). The approach focuses on improving both PTSD symptoms and relationship functioning by providing couples with behavioral tools to address challenges related to PTSD. Participants will undergo therapy sessions that include MDMA to enhance the therapeutic experience. The study aims to gather data on how this combined treatment impacts individuals and their relationships.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of PTSD who have a willing partner to participate in the therapy.

Not a fit: Patients who are not diagnosed with PTSD or those who cannot participate in the required therapy sessions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve PTSD symptoms and enhance relationship satisfaction for affected individuals and their partners.

How similar studies have performed: Previous studies have shown promising results for MDMA-assisted therapies in treating PTSD, indicating potential success for this approach.

Eligibility criteria

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

Where this trial is running

Toronto, Ontario

• Remedy Institute — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Paul Uy, MD — Remedy Institute
• Study coordinator: Song Ge

Conditions Post Traumatic Stress Disorder; MDMA; Cognitive Behavioural Conjoint Therapy; Relationship functioning