Comparing MDMA assisted psychotherapy with Psychotherapy for post traumatic stress disorder
Official title: MDMA-Assisted CBCT for PTSD vs CBCT RCT
A Randomized Trial of MDMA-Assisted Cognitive-Behavioural Conjoint Therapy (CBCT) Versus CBCT in Dyads in Which One Member Has Posttraumatic Stress Disorder (PTSD)
Interventions
MDMA assisted psychotherapy
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.
Psychotherapy
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.
Canadian Sites (1)
Remedy Institute
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for129 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participant with PTSD
- +Participant with PTSD
- +Meet criteria for PTSD
- +Have a close other person who is able and willing to participate in this study
- +Are at least 18 years old
- +Are a resident of Ontario and live within the Greater Toronto Area (GTA)
- +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 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
- +Have a supportive relative, spouse, close friend or other caregiver not participating in this study 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
- +Close Significant Other
- +Have a close other person who meets criteria for PTSD and is able and willing to participate in this study
- +Are at least 18 years old
- +Are a resident of Ontario and live within the Greater Toronto Area (GTA)
- +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 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
- +Have a supportive relative, spouse, close friend or other caregiver not participating in this study who can serve as your emergency contact
- +Agree to inform the researchers within 48 hours of any medical conditions and procedure
- +Agree to not participate in any other clinical trials during this study
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Participant with PTSD
- +Have a history of, or a current psychotic disorder or 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 behaviour or had serious suicidal thoughts (this will be assessed by the study team)
- +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 recently used "Ecstasy" (material represented as containing MDMA)
- +Are not able to give adequate informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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 trialInterventional studyA study where participants are given something to see what happens.Read more →
- +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
- +Meet criteria for PTSD
- +Have a history of, or a current psychotic disorder or 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 behaviour or had serious suicidal thoughts (this will be assessed by the study team)
- +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 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
- +Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant
- +Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant
- +Are pregnant or could become pregnant and not using birth controlControl groupThe group a new treatment is measured against.Read more →
- +Are pregnant or could become pregnant and not using birth control
- +Have current substance use disorder with physiological dependence (not including caffeine or nicotine)
- +Have current substance use disorder with physiological dependence (not including caffeine or nicotine)
Exclusion
- −Participant with PTSD
- −Have a history of, or a current psychotic disorder or 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 behaviour or had serious suicidal thoughts (this will be assessed by the study team)
- −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 recently used "Ecstasy" (material represented as containing MDMA)
- −Are not able to give adequate informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −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 trialInterventional studyA study where participants are given something to see what happens.Read more →
- −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
- −Meet criteria for PTSD
- −Have a history of, or a current psychotic disorder or 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 behaviour or had serious suicidal thoughts (this will be assessed by the study team)
- −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 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
- −Are pregnant or could become pregnant and not using birth controlControl groupThe group a new treatment is measured against.Read more →
- −Are pregnant or could become pregnant and not using birth control
- −Have current substance use disorder with physiological dependence (not including caffeine or nicotine)
- −Have current substance use disorder with physiological dependence (not including caffeine or nicotine)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: MDMA assisted psychotherapy, Psychotherapy.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 80 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: 3-Month Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility of Intervention Measure (FIM) — measured over 3-Month Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
Safety of Intervention — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →) to Follow-up (3-month follow-up).
Intervention Appropriateness Measures (IAM) — measured over 3-month follow-up.
Long Term Follow-Up Questionnaire (LTFUQ) — measured over 3-Month Follow-up.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06044675 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About MDMA assisted psychotherapyDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PsychotherapyBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 80 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3-Month Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
The study as a whole is currently expected to finish around 2027-03-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.