Clinical Trials Logo

Clinical Trial Summary

This study is designed to provide information on whether the drug MDMA, combined with Cognitive Processing Therapy (CPT), is safe and helpful for people with Post Traumatic Stress Disorder (PTSD). PTSD is a serious debilitating disorder that negatively impacts a person's daily life, and can result in diminished functioning, fractured relationships, inability to maintain employment, substance abuse, depression, and suicide risk. People who suffer from PTSD relive their traumatic experience(s) through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. CPT is a manualized treatment for PTSD, which has the participant make meaning of the traumatic event and its impact on their life. CPT is one of the treatments with the best evidence for the treatment of PTSD to date. Clients with PTSD discuss how they believe the trauma has impacted them, and the therapist teaches the client skills to challenge areas where they are "stuck" remembering the traumatic event. 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 CPT. Given the properties of MDMA, specifically in inducing the ability to stay with emotion and challenging cognitions, these effects are especially relevant to the mechanisms of CPT. This is a pilot study exploring CPT integrated with MDMA-assisted psychotherapy for treatment of PTSD. This study will enroll 10 participants diagnosed with PTSD, who will undergo a 2-month course of psychotherapy that includes CPT integrated with MDMA-assisted psychotherapy. Participants will go through CPT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Since this is the first time that CPT is being combined with individual MDMA-assisted psychotherapy for PTSD, the researchers are interested in gathering preliminary information about the blending of these two therapeutic approaches.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05067244
Study type Interventional
Source Remedy
Contact Melanie Munroe, MA
Phone (647) 362-8822
Email [email protected]
Status Recruiting
Phase Phase 2
Start date October 4, 2021
Completion date December 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04460014 - Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT N/A
Recruiting NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Not yet recruiting NCT05033223 - Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services 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 NCT03898843 - Assisted Animal Therapy: ReAnimal N/A
Recruiting NCT03248167 - Cannabidiol as a Treatment for AUD Comorbid With PTSD Phase 1/Phase 2
Recruiting NCT03503981 - Examining Change Mechanisms in Psychotherapy
Completed NCT04501445 - Psychological Symptoms and Families of COVID-19 Patients N/A
Recruiting NCT03922581 - Primary-Care Based Mindfulness Intervention N/A
Not yet recruiting NCT05026450 - Exploring the Psycho-traumatic Impact of a Violent Act Commited at the Bordeaux-Gradignan Penitentiary Center
Completed NCT03166501 - NMDA Receptor Modulation for Hyperarousal in PTSD Phase 1
Recruiting NCT03229525 - Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder N/A
Terminated NCT01430832 - Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
Completed NCT03310112 - Mindfulness Training in U.S. Army Cohorts N/A