MDMA-Assisted CBCT for PTSD vs CBCT RCT — Clinical Trial Details | Blossom
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).
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
Locations
Remedy Institute — Toronto, Ontario, Canada
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
BMI
-
Psychosis History
-
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