Actively Recruiting
MDMA-Assisted CBCT for PTSD vs CBCT RCT
Led by Remedy · Updated on 2024-11-26
60
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
R
Remedy
Lead Sponsor
R
Remedy Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
MDMA-Assisted CBCT for PTSD vs CBCT RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has PTSD and meets PTSD diagnostic criteria
- Participant has a close other willing and able to participate
- Participant is at least 18 years old
- Participant lives in Ontario within the Greater Toronto Area
- Participant is in good physical health
- Participant can speak and read English proficiently
- Participant agrees to have all visits audio and video recorded
- Participant is able to swallow pills
- Participant agrees to follow all study rules and attend all medical and therapy visits
- If in psychotherapy, participant allows study therapists to communicate with their therapist
- Participant is willing to stop psychiatric medications, herbal supplements, and other medications during the study
- Participant agrees to stay overnight twice after full-day MDMA-Assisted Therapy sessions and not drive for 24 hours after MDMA
- Participant is not pregnant and agrees to not become pregnant during the study if able
- Participant has a supportive emergency contact not participating in the study
- Participant agrees to inform researchers within 48 hours of any medical conditions or procedures
- Participant agrees not to join other clinical trials during this study
- Close other meets the above criteria except does not have PTSD
You will not qualify if you...
- Participant is pregnant or could become pregnant without using birth control
- Participant has history or current psychotic disorder, bipolar 1 disorder, or dissociative identity disorder
- Participant has medical conditions making MDMA unsafe (e.g., glaucoma, heart attack, stroke, aneurysm)
- Participant has unstable Type 2 Diabetes Mellitus
- Participant has untreated hypothyroidism
- Participant has high blood pressure, heart disease, heart failure, irregular heart activity, or requires heart medication
- Participant has symptomatic liver disease
- Participant has history of hyponatremia or hyperthermia
- Participant weighs less than 48 kg
- Participant has recent suicidal behavior or serious suicidal thoughts
- Participant requires ongoing psychiatric medication therapy
- Participant has current eating disorder with active purging
- Participant has major depressive disorder with psychotic features
- Participant poses serious risk to others
- Participant recently received Electroconvulsive Therapy (ECT)
- Participant recently engaged in ketamine-assisted therapy or used ketamine
- Participant has current substance use disorder with physiological dependence (excluding caffeine or nicotine)
- Participant recently used "Ecstasy" containing MDMA
- Participant cannot give informed consent or adhere to study requirements
- Participant is involved in compensation litigation for PTSD or psychiatric disorders
- Close other has PTSD or meets above exclusion criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Remedy Institute
Toronto, Ontario, Canada, M6G 1L5
Actively Recruiting
Research Team
S
Song Ge
CONTACT
A
Anne Wagner, C.Psych.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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