Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence

Official 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.

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 65 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 76 participants

Study Arms

• High Dose (EXPERIMENTAL)
  High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (38 participants) administered 24hrs prior to first ACT session
• Low Dose (ACTIVE_COMPARATOR)
  Low Dose (5mg) PEX010 (Oral Psilocybin), 5mg; single dose (20 participants) administered 24hrs prior to first ACT session

Interventions

• DRUG: Psilocybin — See treatment arm description.

Primary Outcomes

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
• PTSD Checklist for DSM-5 (PCL-5) (Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing)

Secondary Outcomes

• Montgomery-Åsberg Depression Rating Scale, Self-Reported (MADRS-S) (Change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing)
• Generalized Anxiety Disorder-7 (GAD-7) (Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing)
• Rivermead Post-Concussion Symptoms Questionnaire (RPQ) (Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing)
• The Acceptance and Action Questionnaire II (AAQ-II) (Change from baseline to 1-week, 4 weeks, and 6 months post-dosing)
• Cognitive Fusion Questionnaire (CFQ-7) (Change from baseline to 1-week, 4 weeks, 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

Trial Locations

• University of Calgary, Calgary, Alberta, Canada
• The University of British Columbia - Okanagan Campus, Kelowna, British Columbia, Canada

Contact Information

• Chantel T Debert, MD MSc FRCPC — CONTACT
  Phone: 403) 944-4500
  Email: cdebert@ucalgary.ca
• Christina Campbell, MSc — CONTACT
  Phone: 403-944-8649
  Email: christina.campbel1@ucalgary.ca

Study Officials

• Sandy Shultz, PhD — PRINCIPAL_INVESTIGATOR
  The Institute on Aging & Lifelong Health, Faculty of Health, University of Victoria
• Leah Mayo, PhD — PRINCIPAL_INVESTIGATOR
  Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine
• 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
• Paul van Donkelaar, PhD — PRINCIPAL_INVESTIGATOR
  Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences

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