Post Traumatic Stress Disorder study: MDMA assisted psychotherapy vs Psychotherapy
Official title MDMA-Assisted CBCT for PTSD vs CBCT RCT
ClinicalTrials.gov ID: NCT06044675
What this study is testing
What is MDMA-assisted psychotherapy?
An investigational treatment combining MDMA with Cognitive-Behavioral Conjoint Therapy being studied for PTSD. MDMA is designed to increase release of serotonin, dopamine, and norepinephrine, which may reduce fear and enhance empathy during therapy.
Also referred to as MDMA-assisted CBCT.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding MDMA to a joint therapy program is safe, doable, and helps reduce PTSD symptoms compared with the therapy alone.
- Who it's for
- Adults who have PTSD and are willing to attend therapy together with a partner or close loved one.
- What's involved
- Participants will attend a 7‑week program of Cognitive‑Behavioral Conjoint Therapy; the MDMA group receives two supervised MDMA doses during therapy sessions, while the other group receives therapy only and may later cross over to MDMA.
- Time commitment
- The trial lasts about 7 weeks with regular therapy visits and a few additional visits for the MDMA dosing sessions.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.