A Treatment Development Study of MDMA-Assisted Psychotherapy for PTSD
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Remedy
Collaborators:
Multidisciplinary Association for Psychedelic Studies Ryerson University