Back to resultsA Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)
Primary Purpose
Post Traumatic Stress Disorder
Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
MDMA
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring MDMA, Cognitive Processing Therapy (CPT)
Eligibility Criteria
Inclusion Criteria:
- Meet criteria for PTSD
- Are at least 18 years old
- Are a resident of Ontario and live within 200km of the study site
- Are in good physical health
- Are proficient in speaking and reading English
- Are willing to have all visits audio and video recorded
- Are able to swallow pills
- Agree to all study rules and commit to all medical and therapy visits
- If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist
- Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study
- Agree not to drive for at least 24 hours after taking MDMA
- Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Psychotherapy Session
- Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant
- Have a supportive relative, spouse, close friend or other caregiver who can serve as your emergency contact
- Agree to inform the researchers within 48 hours of any medical conditions and procedures
- Agree to not participate in any other clinical trials during this study
Exclusion Criteria:
- Are pregnant or could become pregnant and not using birth control
- Have a history of, or a current psychotic disorder, bipolar 1 disorder or dissociative identity disorder
- Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)
- Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable
- Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement
- Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication
- Have liver disease with symptoms
- 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)
- Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)
- Weigh less than 48 kg
- Have recently engaged in suicidal behavior or had serious suicidal thoughts (this will be assessed by a therapist)
- Require ongoing therapy with a psychiatric medication
- Have a current eating disorder with active purging
- Have current major depressive disorder with psychotic features
- Are a serious risk to others
- Have recently received Electroconvulsive Therapy (ECT)
- Have recently engaged in ketamine-assisted therapy or used ketamine
- Have current substance use disorder (not including caffeine or nicotine)
- Have recently used "Ecstasy" (material represented as containing MDMA)
- Are not able to give adequate informed consent
- 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
- Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders
Sites / Locations
- Remedy Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MDMA assisted psychotherapy
Arm Description
Participants will undergo a 2-month course of CPT psychotherapy for PTSD with two sessions that integrate MDMA-assisted psychotherapy. MDMA will be administered ini two separate sessions and integrated into the psychotherapy protocol. The two doses of MDMA during this study will be used as an adjunct to psychotherapy.
Outcomes
Primary Outcome Measures
Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
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.
Change From Baseline to Midpoint (visit 6) in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
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.
Change From Baseline to 1 Month Follow up in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
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.
Change From Baseline to 3 Month Follow up in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
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 Outcome Measures
Change From Baseline to Endpoint in PTSD Symptoms Checklist
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.
Change From Baseline to Midpoint (Visit 6) in PTSD Symptoms Checklist
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.
Change From Baseline to 1 Month Follow up in PTSD Symptoms Checklist
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.
Change From Baseline to 3 Month Follow up in PTSD Symptoms Checklist
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.
Change From Baseline to Endpoint in The Patient Health Questionnaire-9 Depression Symptoms
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.
Change From Baseline to Midpoint (Visit 6) in The Patient Health Questionnaire-9 Depression Symptoms
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.
Change From Baseline to 1 Month Follow up in The Patient Health Questionnaire-9 Depression Symptoms
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.
Change From Baseline to 3 Month Follow up in The Patient Health Questionnaire-9 Depression Symptoms
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.
Full Information
NCT ID
NCT05067244
First Posted
September 19, 2021
Last Updated
September 13, 2023
Sponsor
Remedy
Collaborators
Multidisciplinary Association for Psychedelic Studies
1. Study Identification
Unique Protocol Identification Number
NCT05067244
Brief Title
A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)
Official Title
A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Remedy
Collaborators
Multidisciplinary Association for Psychedelic Studies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
This study is designed to provide information on whether the drug MDMA, combined with Cognitive Processing Therapy (CPT), is safe and helpful for people with Post Traumatic Stress Disorder (PTSD). PTSD is a serious debilitating disorder that negatively impacts a person's daily life, and can result in diminished functioning, fractured relationships, inability to maintain employment, substance abuse, depression, and suicide risk. People who suffer from PTSD relive their traumatic experience(s) through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged.
CPT is a manualized treatment for PTSD, which has the participant make meaning of the traumatic event and its impact on their life. CPT is one of the treatments with the best evidence for the treatment of PTSD to date. Clients with PTSD discuss how they believe the trauma has impacted them, and the therapist teaches the client skills to challenge areas where they are "stuck" remembering the traumatic event.
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 CPT. Given the properties of MDMA, specifically in inducing the ability to stay with emotion and challenging cognitions, these effects are especially relevant to the mechanisms of CPT.
This is a pilot study exploring CPT integrated with MDMA-assisted psychotherapy for treatment of PTSD. This study will enroll 10 participants diagnosed with PTSD, who will undergo a 2-month course of psychotherapy that includes CPT integrated with MDMA-assisted psychotherapy. Participants will go through CPT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Since this is the first time that CPT is being combined with individual MDMA-assisted psychotherapy for PTSD, the researchers are interested in gathering preliminary information about the blending of these two therapeutic approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
MDMA, Cognitive Processing Therapy (CPT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MDMA assisted psychotherapy
Arm Type
Experimental
Arm Description
Participants will undergo a 2-month course of CPT psychotherapy for PTSD with two sessions that integrate MDMA-assisted psychotherapy. MDMA will be administered ini two separate sessions and integrated into the psychotherapy protocol. The two doses of MDMA during this study will be used as an adjunct to psychotherapy.
Intervention Type
Drug
Intervention Name(s)
MDMA
Intervention Description
MDMA assisted psychotherapy
Primary Outcome Measure Information:
Title
Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
Description
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.
Time Frame
Baseline (enrolment) to endpoint (6 month follow up)
Title
Change From Baseline to Midpoint (visit 6) in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
Description
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.
Time Frame
Baseline (enrolment) to midpoint (visit 6, 3-4 weeks)
Title
Change From Baseline to 1 Month Follow up in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
Description
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.
Time Frame
Baseline (enrolment) to 1 month follow up
Title
Change From Baseline to 3 Month Follow up in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score
Description
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.
Time Frame
Baseline (enrolment) to 3 month follow up
Secondary Outcome Measure Information:
Title
Change From Baseline to Endpoint in PTSD Symptoms Checklist
Description
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.
Time Frame
Baseline (enrolment) to endpoint (6 month follow up)
Title
Change From Baseline to Midpoint (Visit 6) in PTSD Symptoms Checklist
Description
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.
Time Frame
Baseline (enrolment) to midpoint (visit 6, 3-4 weeks)
Title
Change From Baseline to 1 Month Follow up in PTSD Symptoms Checklist
Description
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.
Time Frame
Baseline (enrolment) to 1 month follow up
Title
Change From Baseline to 3 Month Follow up in PTSD Symptoms Checklist
Description
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.
Time Frame
Baseline (enrolment) to 3 month follow up
Title
Change From Baseline to Endpoint in The Patient Health Questionnaire-9 Depression Symptoms
Description
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.
Time Frame
Baseline (enrolment) to endpoint (6 month follow up)
Title
Change From Baseline to Midpoint (Visit 6) in The Patient Health Questionnaire-9 Depression Symptoms
Description
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.
Time Frame
Baseline (enrolment) to midpoint (visit 6, 3-4 weeks)
Title
Change From Baseline to 1 Month Follow up in The Patient Health Questionnaire-9 Depression Symptoms
Description
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.
Time Frame
Baseline (enrolment) to 1 month follow up
Title
Change From Baseline to 3 Month Follow up in The Patient Health Questionnaire-9 Depression Symptoms
Description
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.
Time Frame
Baseline (enrolment) to 3 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet criteria for PTSD
Are at least 18 years old
Are a resident of Ontario and live within 200km of the study site
Are in good physical health
Are proficient in speaking and reading English
Are willing to have all visits audio and video recorded
Are able to swallow pills
Agree to all study rules and commit to all medical and therapy visits
If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist
Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study
Agree not to drive for at least 24 hours after taking MDMA
Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Psychotherapy Session
Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant
Have a supportive relative, spouse, close friend or other caregiver who can serve as your emergency contact
Agree to inform the researchers within 48 hours of any medical conditions and procedures
Agree to not participate in any other clinical trials during this study
Exclusion Criteria:
Are pregnant or could become pregnant and not using birth control
Have a history of, or a current psychotic disorder, bipolar 1 disorder or dissociative identity disorder
Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)
Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable
Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement
Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication
Have liver disease with symptoms
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)
Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)
Weigh less than 48 kg
Have recently engaged in suicidal behavior or had serious suicidal thoughts (this will be assessed by a therapist)
Require ongoing therapy with a psychiatric medication
Have a current eating disorder with active purging
Have current major depressive disorder with psychotic features
Are a serious risk to others
Have recently received Electroconvulsive Therapy (ECT)
Have recently engaged in ketamine-assisted therapy or used ketamine
Have current substance use disorder (not including caffeine or nicotine)
Have recently used "Ecstasy" (material represented as containing MDMA)
Are not able to give adequate informed consent
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
Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Bruni, MD
Organizational Affiliation
Remedy Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Wagner, PhD
Organizational Affiliation
Remedy Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Remedy Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6G 1L5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD)
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