Clinical trial NCT06885996: Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
Official title: Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder PTSD
Intimate Partner Violence (IPV)
Keywords: Psychotherapy
Psilocybin
Acceptance and Commitment Therapy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Vancouver Island University
name: University of British Columbia
First posted: 2025-03-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The overall objective of this study 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 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 (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.

Eligibility criteria: Inclusion Criteria:

* Individuals of all sexes, gender identities, and ethnicities
* 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:

* Severe or moderate substance use disorder other than nicotine in past 6 months
* 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

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale, Self-Reported (MADRS-S)
timeFrame: Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
measure: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
timeFrame: Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing
measure: The Acceptance and Action Questionnaire II (AAQ-II)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: Cognitive Fusion Questionnaire (CFQ-7)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: The Sheehan Disability Scale (SDS)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: 9. EuroQol-5D (EQ-5D-5L)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: Cognitive Flexibility Scale (CFS)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: The Trail-Making Test 'B' (TMT-B)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: The Digit Span Task (DS)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: The Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Other outcomes:
measure: Blood biomarkers
timeFrame: Change from baseline to 1-week, 4 weeks, and 6 months post-dosing
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Kelowna
country: Canada
facility: The University of British Columbia - Okanagan Campus
state: British Columbia
city: Nanaimo
country: Canada
facility: Vancouver Island University
state: British Columbia
Study officials:
affiliation: Director, Centre for Trauma and Mental Health Research, Vancouver Island University
name: Sandy Shultz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine
name: Leah Mayo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society
name: Pamela Kryskow, MD, CCFP
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, Department of Psychology, University of British Columbia
name: Zachary Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences
name: Paul van Donkelaar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, Health Sciences, Vancouver Island University, and Visioning and Development Lead, Roots to Thrive Society
name: Shannon Dammes, RN, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Department of Psychology, University of Victoria
name: Jodie Gawryluk, PhD
role: PRINCIPAL_INVESTIGATOR
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