CBCT + MDMA Website Form for Interested Participants

Study 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)


Number of participants to be enrolled

30 pairs (60 total participants)


Sponsor

Remedy Institute

Sponsor Representative: Kim McDonald-Taylor 


Principal Investigator:

Paul Uy, MD

Remedy Institute


Sub-Investigators 

  1. Candice Monson, PhD, Nellie Health 

  2. Anne Wagner, PhD, Remedy Institute

  3. Michael Mithoefer, MD

  4. Annie Mithoefer, BSN, MAPS Public Benefit Corporation

  5. Jeremy Riva-Cambrin, MD, Remedy Institute

  6. Hera Schlagintweit, PhD, Remedy Institute

  7. Jenna Traynor, PhD, McLean Hospital & Remedy Institute

  8. Alison Bruni, MD, Remedy Institute


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).

This study is registered on clinical trials.gov (https://classic.clinicaltrials.gov/ct2/show/NCT06044675)


This is a study to examine the usefulness of combining MDMA with a well-researched type of psychotherapy specifically for posttraumatic stress disorder called Cognitive-Behavioral Conjoint Therapy. If you and your close significant other are deemed eligible, you both will go through a screening appointment by phone, then will meet with study staff for a thorough review of the study procedures prior to enrollment. There will also be assessments with a qualified researcher and a medical doctor that take place around this time to confirm eligibility. If you are enrolled, you and your close significant other will be randomized to one of two conditions, the MDMA with CBCT condition or the CBCT-only condition. Participation in this study will include meeting with study therapists for 7 2-3 hour long CBCT sessions for the CBCT-only condition with an additional 2 full-day CBCT+MDMA sessions in the MDMA with CBCT condition. Participants randomized to the CBCT-only condition will have the option to complete 2 MDMA and integration sessions 3 months after they’ve completed their therapy. 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.

Please fill out this form to see if you initially qualify for participation in our study. 

The below website questionnaire responses are stored on a secure Remedy Institute cloud drive. Only the study staff will have access to your responses.


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Please check the box that indicates your age group:

 *
Please enter your first name: *
Please enter your last name: *
Please enter your email address: *
Please enter a phone number that a study team member can call you at? *
Do you live in the Greater Toronto Area?
 *
What is the first name person you would like to complete the study with? *
What is the last name person you would like to complete the study with?
 *
What is your relationship to this person (i.e., partner, parent, friend, etc.)? *
Please enter an email address we can contact them at: *
Please enter a phone number that a study team member can call them at?
 *
Please check the box that indicates their age group:
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Have you or your close significant other been experiencing PTSD symptoms?
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Are you the individual experiencing these symptoms?
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Is your close significant other the individual experiencing these symptoms?
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Have you or your close significant other experienced PTSD symptoms for at least 6 months?
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Do you or your close significant other know what caused the PTSD?
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Are you or your close significant other currently being treated for PTSD? Select all that apply:

Please check all PTSD symptoms below that you or your close significant other experience:
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Required
Do you or your close significant other take any medications or supplements?
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Have you or your close significant other had ketamine treatment in the last 3 months?
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Are you and your close significant other available for study visits over a 7-week period, including some in-person visits, and available for periodic assessments between the end of treatment and 3 months after?
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Are you and your close significant other available for two all-day therapy sessions that will take place during the 7-week study period?
*
Are you and your close significant other willing to remain overnight at the clinic after each of two day-long MDMA therapy sessions?
 *

If you are comfortable, please select the category or categories that you identify with. Please select all that apply:

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Required

If you are comfortable, please select the category or categories that your close significant other identifies with. Please select all that apply:

 *
Required
Do you are agree to have the answers to your questions sent to the study team.
*
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