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Post Traumatic Stress DisorderPhase 2NCT06044675

MDMA-Assisted CBCT for PTSD vs CBCT RCT

A Phase 2 study testing MDMA assisted psychotherapy and Psychotherapy in people with Post Traumatic Stress Disorder, run by Remedy at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Post Traumatic Stress Disorder
What is being tested?
MDMA assisted psychotherapy and Psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
15 Nov 2024to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • 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 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
  • 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 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

Who cannot join

  • Participant with PTSD
  • Are pregnant or could become pregnant and not using birth control
  • 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
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  • 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 current substance use disorder with physiological dependence (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
  • Close Significant Other
  • Meet criteria for PTSD
  • Are pregnant or could become pregnant and not using birth control
  • 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 current substance use disorder with physiological dependence (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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Song Ge contact

4372914747

research@remedyinstitute.ca

Anne Wagner, C.Psych. contact

647-362-8822 ext. 102

dr.wagner@remedyinstitute.ca

Canada1 site, 1 recruiting

  • Remedy Institute

    Toronto, Ontario, M6G 1L5

    Hajara Abdirahman, BS

    Recruiting

Other trials in Canada

About this study

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)

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.

Read more

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.

Being tested
MDMA assisted psychotherapy, Psychotherapy
Keywords
MDMA, Cognitive Behavioural Conjoint Therapy (CBCT), Relationship functioning
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDMA assisted psychotherapyDrug

    Also called MDMA-assisted CBCT

    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.

  • PsychotherapyBehavioural

    Also called CBCT

    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.

Study groups in NCT06044675
Study groupRoleWhat they receive
MDMA-Assisted CBCT ConditionExperimentalDyads will undergo a 7-week course of CBCT psychotherapy for PTSD with two sessions that integrate MDMA-assisted psychotherapy. MDMA will be administered in 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.
Receives: Drug: MDMA assisted psychotherapy
CBCT-Only ConditionActive comparatorDyads will undergo a 7-week course of CBCT psychotherapy for PTSD. Dyads who have undergone the CBCT-Only condition will have the option to do a crossover and have the two MDMA sessions after follow-up.
Receives: Behavioral: Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Intervention Measure (FIM)

    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).

    Measured: 3-Month Follow-up

  2. Safety of Intervention

    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.

    Measured: Baseline (enrolment) to Follow-up (3-month follow-up)

  3. Intervention Appropriateness Measures (IAM)

    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).

    Measured: 3-month follow-up

  4. Long Term Follow-Up Questionnaire (LTFUQ)

    The Long Term Follow-Up Questionnaire (LTFUQ) is a self-report measure that assesses the long-term benefits and harms of MDMA-assisted therapy.

    Measured: 3-Month Follow-up

  5. Clinician Administered PTSD Scale (CAPS-5)

    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.

    Measured: Baseline (enrolment) to Follow-up (3-month follow-up)

Secondary outcomes (4)

  1. Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5)

    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.

    Measured: Baseline (enrolment) to Follow-up (3-month follow-up)

  2. Quality of Relationships Inventory (QRI)

    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.

    Measured: Baseline (enrolment) to Follow-up (3-month follow-up)

  3. Couple Satisfaction Index (CSI)

    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).

    Measured: Baseline (enrolment) to Follow-up (3-month follow-up)

  4. Patient Health Questionnaire-9 (PHQ-9)

    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.

    Measured: Baseline (enrolment) to Follow-up (3-month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start15 Nov 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06044675
Sponsor's protocol ID
ICAPT1
Status last verified
Aug 2026
First submitted
13 Sep 2023
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MDMA assisted psychotherapy and Psychotherapy in people with Post Traumatic Stress Disorder, run by Remedy at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Song Ge (4372914747, research@remedyinstitute.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Intervention Measure (FIM) (time frame: 3-Month Follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06044675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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