Clinical trial NCT06044675: MDMA-Assisted CBCT for PTSD vs CBCT RCT
Official title: A Randomized Trial of MDMA-Assisted Cognitive-Behavioural Conjoint Therapy (CBCT) Versus CBCT in Dyads in Which One Member Has Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Keywords: MDMA
Cognitive Behavioural Conjoint Therapy (CBCT)
Relationship functioning
Lead sponsor: Remedy
Sponsor class: INDUSTRY
Collaborators: name: Remedy Institute
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 3-Month Follow-up
measure: Safety of Intervention
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Intervention Appropriateness Measures (IAM)
timeFrame: 3-month follow-up
measure: Long Term Follow-Up Questionnaire (LTFUQ)
timeFrame: 3-Month Follow-up
measure: Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Quality of Relationships Inventory (QRI)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Couple Satisfaction Index (CSI)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
Other outcomes:
measure: Posttraumatic Growth Inventory (PTGI)
timeFrame: Baseline (enrolment) to Follow-up (3 month follow-up)
measure: Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test-Revised (CUDIT-R), and Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Brief Posttraumatic Cognitions Inventory (PTCI-9)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: MOS Social Support Survey (MOS-SSS)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Significant Others' Responses to Trauma Scale (SORTS)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Modified Experiences in Close Relationships (ECR-M16)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Psychological Insights Questionnaire (PIQ)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Mystical Experiences Questionnaire (MEQ30)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline (enrolment) to Follow-up (3-month follow-up)
measure: Credibility Expectancy Questionnaire (CEQ)
timeFrame: Baseline (enrolment)
measure: Working Alliance Inventory-Observer Form (WAI-O)
timeFrame: First therapy session, Mid-point, and Follow-up (3-month follow-up)
Locations:
city: Toronto
country: Canada
facility: Remedy Institute
state: Ontario
Study officials:
affiliation: Remedy Institute
name: Paul Uy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Remedy Institute
name: Anne Wagner, PhD
role: STUDY_CHAIR
References: