A Phase 2 Open-Label Treatment Development Study... — Clinical Trial Details

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.

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

Company

Product

Legal

A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

MDMA-assisted CPT

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators