Self-experience in MDMA assisted therapy of PTSD
Bessel Van der Kolk, Julie B. Wang, Rachel Yehuda, Leah Bedrosian, Allison Cooker, Charlotte Harrison, Michael C Mithoefer, Berra Yazar-Klosinki, Amy Emerson, Rick Doblin
medRxiv Preprint Server January 3, 2023 preprint DOI: 10.1101/2023.01.03.23284143 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized, double-blind, placebo-controlled, multi-site Phase 3 clinical trial |
|---|---|
| Population | Patients with severe PTSD |
| Intervention | MDMA-assisted therapy |
| Duration | 2 months after the last experimental session |
| Topics | Psychedelic-assisted therapy MDMA PTSD |
| Keywords | PTSD Treatment Trauma recovery Mental health intervention Psychiatric treatment Psychological healing Trauma therapy MDMA Therapy Ecstasy treatment Empathogen therapy Drug-assisted psychotherapy Pharmacotherapy MDMA-Assisted Psychotherapy Emotional healing Self-compassion Emotional coping Emotional regulation Psychological well-being Affective processing Resilience building Clinical research Randomized trial Medical study Therapeutic investigation Efficacy study Scientific study Clinical trial |
| Citations | 2 |
| Registration | NCT03537014 |
| Key findings | MDMA-assisted therapy significantly improved alexithymia, self-compassion, and altered self-capacities compared to psychotherapy alone. |
Abstract
In recent years there has been a resurgence of interest in the therapeutic potential of psychedelic substances such as 3,4-methylenedioxymethamphetamine (MDMA). This renaissance of psychedelic studies opens the door for a new paradigm in psychiatric medicine: drug-facilitated psychotherapy. In this study we report the findings of a randomized, double-blind, placebo-controlled, multi-site Phase 3 clinical trial (NCT03537014) to test the effects of MDMA-assisted therapy (MDMA-AT) on patients with severe PTSD. The vast majority (85%) of individuals in this study reported having suffered early childhood trauma, which is strongly associated with deficits in emotional coping skills /altered self-capacities, which have been shown to constitute major obstacles to successful completion of currently available evidence-based treatments. Partcicipants were randomized 1:1 to receive manualized therapy with either MDMA or placebo with three preparatory and nine integrative therapy sessions. Symptoms were measured at baseline and at 2□ months after the last experimental session with the Clinician-Administered PTSD Scale for DSM-5, the Toronto Alexithymia Scale (TAS_20), the Self Compassion Scale (SCS) and the Inventory of Altered Self-Capacities (IASC). MDMA-AT, compared with psychotherapy alone, significantly altered the domains of alexithymia, self-compassion, and altered self-capacities. These findings suggest that MDMA-AT can substantially improve transdiagnostic mental processes associated with poor treatment response.
Comparable studies
Other randomized controlled trials on MDMA and psychedelic-assisted therapy, most cited first.