Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
NCT ID: NCT06885996
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
76 participants
INTERVENTIONAL
2026-08-01
2029-08-01
Brief Summary
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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.
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Detailed Description
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This trail will test the following 2 aims:
AIM 1 : To compare the efficacy of a therapeutic psilocybin dose (25mg) at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose (1mg) (allocation ratio 1:1) in IPV survivors with chronic PTSD. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (PCL-5 only), and 6 months post-psilocybin administration).
AIM 2: to evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (online only), and 6 months post-psilocybin administration).
The secondary efficacy outcomes will include measures of mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life.
Exploratory Aim: Exploratory objectives of this study include evaluating blood biomarkers reflective of inflammation, growth factors, brain injury, and oxidative stress relevant to PTSD and psilocybin's mechanisms of action.
A total of 76 male and female patients between the ages of 18-65 with the last incident of IPV greater than 6 months prior with a score of 1 on the Composite Abuse Scale with repetition of abusive events, meeting DSM-5 criteria for PTSD and a minimum PCL-5 score of 33.
All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (38 participants) or low dose (38 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5-6 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months (online only), and 6 months post-dosing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The pharmacies administering the psilocybin will be responsible for maintaining the master randomization code list and only the technician preparing the samples will have access to the envelopes and code list.
When a new study ID is generated, the technician is to verify the randomization and prepare the participant's study intervention accordingly. Unblinding will only occur once the entire study is completed, and the database has been locked.
The trials active intervention and comparator will be provided by the manufactures and will be identical in shape, colour, and weight.
Study Groups
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High Dose
High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (38 participants) administered 24hrs prior to first ACT session
No interventions assigned to this group
Low Dose
Low Dose (1mg) PEX010 (Oral Psilocybin), 1mg; single dose (20 participants) administered 24hrs prior to first ACT session
Psilocybin
See treatment arm description.
Interventions
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Psilocybin
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Eligibility Criteria
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Inclusion Criteria
* Ages 19 to 65 years at the time of screening
* At least 6 months since last IPV incident
* A score of 1 on the Composite Abuse Scale with repetition of abusive events
* Minimum PCL-5 score of ≥ 33
* Limited lifetime use of serotonergic hallucinogens
* Ability to read/write English
Exclusion Criteria
* Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative)
* Active suicidal ideation or serious attempt within the past 1 year.
* Current pregnancy or nursing, trying to become pregnant
* Any notable abnormality on ECG or routine medical blood laboratory test
* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
* Epilepsy with a history of seizures
* Current or recent (within 12 weeks) participation in a clinical trial
* Cognitive impairment (SLUMS score \<20)
* Suffered a moderate/severe TBI at least once in lifetime
* Suffered a mild TBI within the last 6 months
* Any other circumstances that, in the opinion of the investigators, compromises participant safety
* Not compelled to enter treatment to avoid legal consequences
18 Years
65 Years
ALL
No
Sponsors
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Vancouver Island University
UNKNOWN
University of British Columbia
OTHER
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Sandy Shultz, PhD
Role: PRINCIPAL_INVESTIGATOR
Director, Centre for Trauma and Mental Health Research, Vancouver Island University
Leah Mayo, PhD
Role: PRINCIPAL_INVESTIGATOR
Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine
Pamela Kryskow, MD, CCFP
Role: PRINCIPAL_INVESTIGATOR
Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society
Zachary Walsh, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor, Department of Psychology, University of British Columbia
Paul van Donkelaar, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences
Shannon Dammes, RN, MPH
Role: PRINCIPAL_INVESTIGATOR
Professor, Health Sciences, Vancouver Island University, and Visioning and Development Lead, Roots to Thrive Society
Jodie Gawryluk, PhD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor, Department of Psychology, University of Victoria
Locations
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University of Calgary
Calgary, Alberta, Canada
The University of British Columbia - Okanagan Campus
Kelowna, British Columbia, Canada
Vancouver Island University
Nanaimo, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REB25-0065
Identifier Type: -
Identifier Source: org_study_id
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