A Randomized Trial of MDMA-Assisted Cognitive-Behavioural Conjoint Therapy (CBCT) versus CBCT in Dyads in Which One Member has Posttraumatic Stress Disorder (PTSD)

Remedy Institute is conducting a research study in collaboration with the Multidisciplinary Association for Psychedelic Studies (MAPS). Details on the study and how to determine if you are eligible are below.

This study is funded by a not-for-profit organization, the Multidisciplinary Association for Psychedelic Studies (MAPS). The study will take place at Remedy (201-703 Bloor St. W., Toronto, ON), and has been reviewed and approved by the WCG IRB (#20234243).

Purpose of the study

This research study will combine Cognitive-Behavioral Conjoint Therapy (CBCT), a well-known dyadic treatment for Posttraumatic Stress Disorder (PTSD) with MDMA.
This is the second time these two therapeutic approaches will be blended together, making this an experimental study.
This study is registered on clinical trials.gov.

What is PTSD?

PTSD is a mental health condition that can occur following a trauma

What are some possible signs of PTSD?

Feeling the world is unsafe
Upsetting memories
Anger and irritability
Loss of trust in others
Feeling emotionally numb
Avoiding upsetting memories of trauma
Often feeling on “high alert”
Difficulty sleeping or nightmares

Some sources of trauma can include*?

Physical or sexual abuse or assault
Domestic violence
Fire or natural disasters
Racism and discrimination
Racial profiling
Assault by law enforcement
Urban or gang violence
Incarceration
Pregnancy and childbirth experiences
Ethnic cleansing and persecution
Experiencing or witnessing torture
Living in a warzone
Immigration difficulties
Deportation
Military service
Motor vehicle accidents
Medical conditions and procedures

*Not everyone who experiences trauma develops PTSD. This does not mean the experience you had was not extremely challenging. PTSD is just one outcome that can happen after trauma.

What is CBCT?

CBCT is one of the top dyadic treatments for PTSD.
CBCT helps couples or close significant others understand the impact that trauma has had on the way we think about ourselves, others, their relationship, and the world.
We are committed to providing CBCT in a way that is respectful to people of all backgrounds and experiences.

What is MDMA?

MDMA is the active ingredient in Ecstasy.
MDMA makes it easier to recall memories of the trauma and talk about the effects of trauma with less overwhelming feelings.
MDMA combined with therapy has been shown to be effective for treating PTSD.
MDMA is viewed as a therapeutic tool, rather than a “cure” for PTSD.

Is this treatment safe?

To date over 1200 people have been given MDMA in controlled research settings.
There have been no deaths, disabilities, or addictions as a result and no serious unexpected medical issues have happened
In this study, MDMA is administered twice over 7 weeks, unlike many medications for PTSD which need to be taken daily for years

Approximate Enrollment Dates

Summer 2025

Number of dyads to be enrolled

30 (60 participants total)

Study visit overview and commitment

Interested volunteers can go through an initial eligibility screening questionnaire.
If you are deemed eligible you will be contacted to do a brief phone screen with study staff, consisting of questions related to mental health and medical history to assess suitability for the study.
If after the phone screen you are deemed eligible, you will meet with study staff for a thorough review of the study procedures and what your participation will consist of.
There will also be assessments with a qualified researcher and a medical doctor that take place around this time to confirm eligibility.
This is a randomized trial where participants will be assigned to either a CBCT+MDMA condition or a CBCT-only condition. Participation in this study will include meeting with study therapists for seven 2-3 hour CBCT sessions over 7 weeks. Those in the CBCT+MDMA condition will also receive 2 full-day CBCT+MDMA sessions during the 7 week time period.
Participants in the CBCT-only condition will have the option to participate in 2 MDMA and integration sessions after the 3 month follow-up.
Participants will complete questionnaires and meet with qualified researchers who will ask questions about their symptoms before they start the study, halfway through the study, and 1-2 weeks, and 3 months after treatment ends.