MDMA-Assisted CBCT for PTSD vs CBCT RCT

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06044675
Study type	Interventional
Source	Remedy
Contact	Hajara Abdirahman, BS
Phone	4372914747
Email	research@remedyinstitute.ca
Status	Recruiting
Phase	Phase 2
Start date	October 15, 2023
Completion date	October 15, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05915013` - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response	Phase 1
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Recruiting	`NCT05934162` - Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD	N/A
Recruiting	`NCT05934175` - Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder	N/A
Completed	`NCT04460014` - Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT	N/A
Completed	`NCT05877807` - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Active, not recruiting	`NCT05992649` - The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject	N/A
Terminated	`NCT04404712` - FAAH Availability in Psychiatric Disorders: A PET Study	Early Phase 1
Not yet recruiting	`NCT05331534` - Effect of Attentional Therapy on Post-traumatic Stress Disorder	N/A
Not yet recruiting	`NCT03649607` - Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black	N/A
Not yet recruiting	`NCT04076215` - Biochemical and Physiological Response to Stressogenic Stimuli	N/A
Not yet recruiting	`NCT02545192` - A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments	Phase 1
Completed	`NCT02329418` - Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit	N/A
Active, not recruiting	`NCT00978484` - A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder	Phase 3
Completed	`NCT00760734` - Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)	Phase 1
Completed	`NCT03278171` - Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
Recruiting	`NCT05874362` - People Bereaved by Violent Death : Negative Event Biases and Temporal Perception	N/A
Terminated	`NCT03898843` - Assisted Animal Therapy: ReAnimal	N/A
Recruiting	`NCT04747379` - Psychological Effect of Explicit Recall After Sedation (PEERS)
Completed	`NCT03248167` - Cannabidiol as a Treatment for AUD Comorbid With PTSD	Phase 1/Phase 2