Clinical TrialPTSDMDMACompleted
A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)
This open-label Phase II trial (n=10) investigates the safety and efficacy of MDMA-assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD).
Target Enrollment
10 participants
Study Type
Phase II interventional
Design
Non-randomized
Registry
Detailed Description
Open-label Phase II pilot of Cognitive Processing Therapy integrated with two MDMA-assisted psychotherapy sessions over a 2-month course in participants with PTSD (n=10).
Primary aims are to assess safety, tolerability, and preliminary clinical benefit; MDMA is hypothesised to reduce fear and increase emotional engagement to enhance CPT mechanisms.
Study Protocol
Preparation
sessions
Dosing
2 sessions
480 min each
Integration
sessions
Therapeutic Protocol
cbt
Study Arms & Interventions
MDMA-assisted CPT
experimentalParticipants receive Cognitive Processing Therapy integrated with two MDMA-assisted psychotherapy sessions across a 2-month course.
Interventions
- MDMAvia Oral• two sessions
Two single-dose MDMA sessions administered as adjuncts to CPT; participants stay overnight after each full-day session.
Participants
Ages
18 – 99
Sexes
Male & Female
BMI
-
Psychosis History
-
Inclusion Criteria
- Inclusion Criteria:
- 1. Meet criteria for PTSD
- 2. Are at least 18 years old
- 3. Are a resident of Ontario and live within 200km of the study site
- 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 not to drive for at least 24 hours after taking MDMA
- 12. Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Psychotherapy Session
- 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 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
Exclusion Criteria
- Exclusion Criteria:
- 1. Are pregnant or could become pregnant and not using birth control
- 2. Have a history of, or a current psychotic disorder, 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 behavior or had serious suicidal thoughts (this will be assessed by a therapist)
- 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 (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