RecruitingPHASE2INTERVENTIONAL

MDMA-Assisted CBCT for PTSD vs CBCT RCT

This study is testing a new way to help people with Post-Traumatic Stress Disorder (PTSD) and their loved ones. It compares a type of couples therapy called Cognitive-Behavioral Conjoint Therapy (CBCT) with the same therapy but with added MDMA sessions. PTSD can make relationships very difficult, and CBCT helps couples deal with these challenges together. MDMA is thought to help people feel less fearful, communicate more openly, and feel more connected during therapy. The study wants to find out if adding MDMA makes the therapy safer, more helpful, and easier for people to stick with, compared to CBCT alone. It's a small study involving 30 couples.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Remedy

Enrolment target

Start

15 Nov 2024

Estimated completion

31 Dec 2026

Post Traumatic Stress Disorder

What is this study about?

This research is looking into better ways to help people who have Post-Traumatic Stress Disorder, also known as PTSD. If you or someone you know has PTSD, you'll know how tough it can be, especially on relationships. This study focuses on a type of therapy called Cognitive-Behavioral Conjoint Therapy, or CBCT. This therapy is special because it works with both the person with PTSD and their close loved one, helping them tackle PTSD symptoms and improve their relationship at the same time. It gives couples tools to understand how PTSD affects them and how to work through it together.

Alongside this therapy, the study is also looking at whether a medicine called MDMA can help. You might have heard of MDMA in other contexts, but scientists are now studying if it can be useful in a carefully controlled medical setting. When used with therapy, MDMA is believed to help people feel less afraid, more open to sharing, and more understanding towards others. This could make it easier to talk about difficult experiences and make better progress in therapy, without feeling overwhelmed by strong emotions linked to traumatic memories.

The main goal of this study is to see if combining MDMA with CBCT is safe, effective, and something people are willing to try. It compares this combination to just having CBCT therapy on its own. Researchers hope to learn if adding MDMA can make the therapy even more successful in reducing PTSD symptoms, improving how couples get along, and boosting overall happiness in relationships.

Key takeaways

This study explores a new way to treat PTSD involving couples therapy.
It compares therapy alone with therapy aided by a medicine called MDMA.
The goal is to see if MDMA can help people with PTSD and their partners communicate better and reduce symptoms.
Participation requires both the person with PTSD and a close loved one.
Safety is a top priority, with careful medical supervision and overnight stays after MDMA sessions.
You have the right to withdraw from the study at any time.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and live within the Greater Toronto Area in Ontario, Canada. One of you in the couple must have been diagnosed with PTSD and have a close partner or loved one who is willing to join the study with you. Both partners need to be generally healthy and able to speak and read English well.

You and your partner should be able to swallow pills and agree to follow all the study rules, including attending all therapy and medical appointments. If you're currently seeing another therapist, you'll need to allow the study therapists to speak with them. Importantly, you'll also need to be willing to stop taking most other psychiatric medications, herbal products, and prescription drugs for the duration of the study.

There are also specific requirements for safety around the MDMA sessions. If you're able to get pregnant, you must not be pregnant and agree not to become pregnant during the study. Both partners will need to stay overnight twice after the MDMA sessions and agree not to drive for at least 24 hours afterwards. You also cannot participate in any other clinical studies while taking part in this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you live in the Greater Toronto Area (Ontario, Canada)?
Does one of you have a PTSD diagnosis and is the other a close loved one willing to participate?
Are both of you generally healthy and able to speak/read English?
Are you willing to stop most other medications for the study?
Are you able to commit to overnight stays and therapy appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, which will last about 7 weeks, you and your partner will be assigned by chance to one of two groups. One group will receive the special couples therapy (CBCT) on its own. The other group will receive the same couples therapy, but they will also have two separate therapy sessions where MDMA is used.

During the MDMA-assisted sessions, you will take the medicine, and then you and your partner will spend a full day in therapy. Afterwards, for your safety, you'll need to stay overnight in a supervised setting. You'll also need to commit to not driving for at least 24 hours after taking MDMA. All your study visits, including therapy sessions, will be audio and video recorded. Those in the CBCT-only group will have the chance to receive the MDMA-assisted sessions after the main study follow-up is complete.

Throughout the study, you'll have regular medical check-ups and therapy sessions tailored to your group. You'll be asked to inform the researchers within 48 hours if you experience any new medical conditions or procedures. This study involves a significant time commitment and adherence to specific rules for your safety and to ensure the study provides accurate information.

Potential risks and benefits

This study could potentially offer important insights into new ways to treat PTSD, which might lead to better well-being and healthier relationships for you and your loved one. The MDMA is given in a carefully controlled medical environment, which is different from recreational use, and the study will closely monitor your safety. However, as with all research, there are potential risks; MDMA can have side effects, and some people might find the therapy emotionally challenging. You will be fully informed of all potential risks before deciding to participate. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Remedy Institute
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is PTSD?

PTSD, or Post-Traumatic Stress Disorder, is a condition that can develop after someone experiences or witnesses a shocking, scary, or dangerous event. It can cause ongoing feelings of fear, anxiety, and flashbacks, making everyday life and relationships very difficult.

What is MDMA?

MDMA is a medicine being researched for its potential to help with therapy. Unlike recreational use, in this study, it's given in a controlled medical setting by trained professionals to see if it can help people open up, communicate better, and process difficult emotions during therapy sessions.

What is CBCT?

CBCT stands for Cognitive-Behavioral Conjoint Therapy. It's a type of therapy specifically designed for couples where one person has PTSD. It helps both partners understand PTSD's impact on their relationship and gives them tools to manage symptoms and improve how they interact.

Will I definitely get the MDMA sessions?

Not necessarily. This is a "randomized" study, meaning you'll be assigned by chance to either receive the MDMA-assisted therapy or the CBCT-only therapy. However, if you are in the CBCT-only group, you will have the opportunity to receive the MDMA sessions after the main part of the study is finished.

Do I have to stop all my current medications?

Yes, you generally need to be willing to stop taking most other psychiatric medications, herbal supplements, and some prescription drugs during the study. This is important to ensure the study can accurately measure the effects of the MDMA and therapy without interference from other substances.

How to find out more

Song Ge

research@remedyinstitute.ca 4372914747 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.