Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder
(PsiPTSD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether psilocybin, a psychedelic compound, can reduce PTSD symptoms in survivors of intimate partner violence. Participants will receive either a high or low dose of psilocybin, combined with Acceptance and Commitment Therapy, which focuses on mindfulness and behavior change. The study aims to determine if psilocybin can enhance quality of life and mental functions like mood and thinking skills. This trial may suit those who have experienced intimate partner violence, have had PTSD for over six months, and have limited past use of psychedelic drugs. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that psilocybin, a substance found in some mushrooms, is generally safe when used with psychological support. Studies have found that a 25 mg dose is well-tolerated, with no serious harm reported. In earlier research, participants showed some improvement in symptoms of depression and PTSD (post-traumatic stress disorder).
For the smaller 1 mg dose, research is less detailed, but it is likely even more tolerable due to its lower amount. Both doses are under study to better understand their safety and effects. Current evidence suggests that therapy with psilocybin might be a promising way to reduce PTSD symptoms and improve overall well-being.12345Why do researchers think this study treatment might be promising for PTSD?
Unlike standard PTSD treatments like SSRIs or cognitive behavioral therapy, psilocybin-assisted therapy uses psilocybin, a psychedelic compound, to help patients process their trauma in a new way. Researchers are excited because psilocybin targets serotonin receptors in the brain, potentially leading to rapid and profound shifts in mood and perception. Additionally, psilocybin's effects can occur after just one or two administrations, offering a faster-acting alternative to traditional methods that usually require ongoing sessions. This unique approach could provide a transformative experience that helps patients find relief more quickly.
What evidence suggests that this trial's treatments could be effective for PTSD?
This trial will compare the effects of different doses of psilocybin on PTSD symptoms. Research has shown that psilocybin, a substance found in some mushrooms, might help reduce PTSD symptoms. Studies have found that just one dose, combined with therapy, can effectively lessen these symptoms. Early results suggest that people feel better mentally after receiving psilocybin in a controlled therapy setting. Evidence also indicates that psilocybin might improve the quality of life and cognitive abilities in people with PTSD. While more research is needed, these findings are encouraging for those considering this treatment.13467
Who Is on the Research Team?
Pamela Kryskow, MD, CCFP
Principal Investigator
Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society
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
Sandy Shultz, PhD
Principal Investigator
Director, Centre for Trauma and Mental Health Research, Vancouver Island University
Leah Mayo, PhD
Principal Investigator
Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine
Zachary Walsh, PhD
Principal Investigator
Professor, Department of Psychology, University of British Columbia
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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