Clinical TrialPTSDMDMARecruiting

MDMA-Assisted CBCT for PTSD vs CBCT RCT

This interventional trial (n=60) aims to assess the efficacy and safety of MDMA-Assisted Cognitive-Behavioural Conjoint Therapy (CBCT) compared to CBCT alone in dyads where one member has Post-Traumatic Stress Disorder (PTSD).

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

This randomized trial will compare MDMA-assisted CBCT to CBCT alone in 30 dyads (60 participants) over a 7-week psychotherapy course, using two MDMA-assisted therapy sessions as adjunctive treatment.

CBCT is a manualized dyadic PTSD treatment addressing symptoms and relationship functioning; the study will assess feasibility, safety, acceptability, and effectiveness relative to active comparator.

MDMA is hypothesised to enhance therapeutic engagement, empathy and communication, allowing deeper processing of traumatic memories when integrated into CBCT; CBCT-only participants may crossover to receive MDMA sessions after follow-up.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

MDMA-Assisted CBCT

experimental

CBCT with two MDMA-assisted psychotherapy sessions as adjunct over a 7-week course.

Interventions

  • MDMA
    via Oral• two sessions• 2 doses total

    MDMA administered in two separate therapy sessions as adjunct to CBCT; dose not specified in registry.

CBCT only

active comparator

7-week manualized Cognitive-Behavioural Conjoint Therapy without MDMA; option to crossover to MDMA after follow-up.

Interventions

  • Compound

    Manualized CBCT psychotherapy (7-week course).

Participants

Ages
18 – 80
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria
  • Participant with PTSD:
  • 1. Meet criteria for PTSD
  • 2. Have a close other person who is able and willing to participate in this study
  • 3. Are at least 18 years old
  • 4. Are a resident of Ontario and live within the Greater Toronto Area (GTA)
  • 5. Are in good physical health
  • 6. Are proficient in speaking and reading English
  • 7. Are willing to have all visits audio and video recorded
  • 8. Are able to swallow pills
  • 9. Agree to all study rules and commit to all medical and therapy visits
  • 10. If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist
  • 11. Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study
  • 12. 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
  • 13. Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant
  • 14. Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact
  • 15. Agree to inform the researchers within 48 hours of any medical conditions and procedures
  • 16. 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 procedures
  • 15. Agree to not participate in any other clinical trials during this study

Exclusion Criteria

  • 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
  • 9. Have history of hyperthermia
  • 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 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
  • 10. Have history of hyperthermia
  • 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

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment60 participants
  • Timeline
    Start: 2023-10-15
    End: 2026-10-15
  • Compound
    MDMA
  • Topic
    PTSD

Locations

Remedy Institute — Toronto, Ontario, Canada

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