Post Traumatic Stress Disorder
Conditions
Keywords
MDMA, Cognitive Behavioural Conjoint Therapy (CBCT), Relationship functioning
Brief summary
This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery. CBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads. MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness. This randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.
Interventions
This treatment combines MDMA with a well researched treatment for PTSD for dyads known as CBCT. Dyads will undergo a 7-week course of psychotherapy with two doses of MDMA will be used as an adjunct to psychotherapy.
BEHAVIORALPsychotherapy
A manualized treatment for PTSD for dyads wherein one person has symptoms of PTSD. This intervention is 7-week course of psychotherapy that is designed to simultaneously improve PTSD symptoms and relationship functioning through education and skill training.
Sponsors
Remedy
Remedy Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure (FIM) | 3-Month Follow-up | The Feasibility of Intervention Measure (FIM) is a self-report questionnaire in which respondents indicate the extent to which they believe that the treatment can be delivered in a given setting. Respondents indicate their responses on a five-point Likert-type (1=completely disagree, 5= completely agree). |
| Safety of Intervention | Baseline (enrolment) to Follow-up (3-month follow-up) | Safety will be assessed by examining the frequency and severity of adverse events (AEs), serious AEs (SAEs), treatment emergent AES (TEAEs), and AEs of special interest. Participants are asked to report any AEs, SAEs, TEAEs, and AEs of special interest as they happen and during any communication with the therapist or independent assessor. |
| Intervention Appropriateness Measures (IAM) | 3-month follow-up | Intervention Appropriateness Measures (IAM) is a self-report measure of the perceived fit, relevance, or compatibility of an intervention. Respondents record their answers on a five-point Likert-type scale (1=completely disagree, 5= completely agree). |
| Long Term Follow-Up Questionnaire (LTFUQ) | 3-Month Follow-up | The Long Term Follow-Up Questionnaire (LTFUQ) is a self-report measure that assesses the long-term benefits and harms of MDMA-assisted therapy. |
| Clinician Administered PTSD Scale (CAPS-5) | Baseline (enrolment) to Follow-up (3-month follow-up) | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5) | Baseline (enrolment) to Follow-up (3-month follow-up) | PTSD Checklist for the DSM-5 (PCL-5) is a self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the DSM-5 symptoms of PTSD. Participants indicate how much distress they have experienced due to symptoms on a five-point Likert-type scale (1 = not at all, 5 = extremely). The total PCL-5 score (a sum of all 20 items) provides an index of overall PTSD symptom severity with higher scores indicating higher severity. |
| Quality of Relationships Inventory (QRI) | Baseline (enrolment) to Follow-up (3-month follow-up) | The Quality of Relationships Inventory (QRI) is a self-report questionnaire that uses the role of situational, intrapersonal, and interpersonal in social support processes to assess supportive and conflictual aspects of close non-intimate relationships. |
| Couple Satisfaction Index (CSI) | Baseline (enrolment) to Follow-up (3-month follow-up) | The Couple Satisfaction Index (CSI) is a self-report questionnaire that measures intimate relationship functioning. Respondents answer most of the questions on a six-point Likert-type scale (0= never, 5= all the time) and one question on a seven-point Likert-type scale ( 0= extremely unhappy, 6= perfect). |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline (enrolment) to Follow-up (3-month follow-up) | The Patient Health Questionnaire-9 (PHQ-9) is used to assess depressive symptom severity. The PHQ-9 includes items which correspond with the diagnostic criteria for DSM-IV major depressive disorder. Scores can indicate either no depression, minimal, mild, moderate, moderately severe, or severe depression. Higher scores indicate higher severity in depressive symptoms. |
Countries
Canada
Contacts
CONTACTSong Ge
CONTACTAnne Wagner, C.Psych.
PRINCIPAL_INVESTIGATORPaul Uy, MD
Remedy Institute
STUDY_CHAIRAnne Wagner, PhD
Remedy Institute
Outcome results
None listed