Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder
(PsiPTSD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug psilocybin for treating PTSD?
Research suggests that psilocybin-assisted therapy may help reduce PTSD symptoms by decreasing emotional avoidance and increasing acceptance and self-compassion. Although no direct studies on PTSD exist, psilocybin has shown promise in treating related conditions like depression and anxiety, and early evidence indicates it may help with PTSD symptoms in combat veterans.12345
Is psilocybin-assisted therapy safe for humans?
Psilocybin-assisted therapy appears generally safe when administered under supervision, with most side effects being mild and temporary. However, there are rare reports of increased suicidal thoughts and challenging experiences, especially at higher doses or without proper support, so further research is needed to fully understand its safety.12678
How is psilocybin-assisted therapy different from other PTSD treatments?
Psilocybin-assisted therapy is unique because it uses a psychedelic drug, psilocybin, in combination with psychotherapy to help patients confront and process traumatic memories, which may lead to long-term improvements after just a few sessions. Unlike traditional PTSD treatments, which can be hard to tolerate and often have limited effectiveness, this approach shows promise in promoting emotional healing and reducing symptoms by enhancing neuroplasticity (the brain's ability to change and adapt).12359
What is the purpose of this trial?
The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV).This trail will test the following 2 aims:AIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD.AIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility.Participants will be asked to:* Complete a 2 part screening process* Attend a baseline assessment* Complete a psychoeducation preparation session(s)* Attend psilocybin administration session (receive high dose \[25mg\] or low dose psilocybin \[1mg\])* Complete 5-6 weekly sessions of ACT* Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.
Research Team
Leah Mayo, PhD
Principal Investigator
Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine
Sandy Shultz, PhD
Principal Investigator
Director, Centre for Trauma and Mental Health Research, Vancouver Island University
Pamela Kryskow, MD, CCFP
Principal Investigator
Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society
Zachary Walsh, PhD
Principal Investigator
Professor, Department of Psychology, University of British Columbia
Shannon Dammes, RN, MPH
Principal Investigator
Professor, Health Sciences, Vancouver Island University, and Visioning and Development Lead, Roots to Thrive Society
Paul van Donkelaar, PhD
Principal Investigator
Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences
Jodie Gawryluk, PhD
Principal Investigator
Associate Professor, Department of Psychology, University of Victoria
Eligibility Criteria
Adults aged 18-65 who have survived intimate partner violence and suffer from chronic PTSD can join this trial. They must complete a two-part screening, attend assessments, psychoeducation sessions, and ACT therapy post-psilocybin administration. Those with certain health conditions or on conflicting medications may be excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants attend a baseline assessment consisting of clinical and behavioral outcome measures
Psychoeducation Preparation
Participants complete a psychoeducation preparation session(s) prior to psilocybin administration
Psilocybin Administration
Participants receive a single dose of psilocybin (either high dose 25mg or low dose 1mg) administered 24 hours prior to the first ACT session
Acceptance and Commitment Therapy (ACT)
Participants complete 5-6 weekly sessions of Acceptance and Commitment Therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment with outcome measures repeated at 1-week, 4 weeks, 3 months (online only), and 6 months post-psilocybin administration
Treatment Details
Interventions
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Vancouver Island University
Collaborator
University of British Columbia
Collaborator