Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence (PsiPTSD Trial)

Calgary, Canada

Phase 2

Waitlist Available

Led By Sandy Shultz, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Individuals of all sexes, gender identities, and ethnicities

* Ages 19 to 65 years at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing

Awards & highlights

No Placebo-Only Group

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.

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Eligible Conditions

Domestic Violence
Post-Traumatic Stress Disorder

Eligibility Criteria

Inclusion Criteria

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* Individuals of all sexes, gender identities, and ethnicities

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* Ages 19 to 65 years at the time of screening

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* At least 6 months since last IPV incident

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* A score of 1 on the Composite Abuse Scale with repetition of abusive events

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* Minimum PCL-5 score of ≥ 33

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* Limited lifetime use of serotonergic hallucinogens

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* Ability to read/write English

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1-week, 4 weeks, 3 months, and 6 months post-dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

PTSD Checklist for DSM-5 (PCL-5)

Secondary study objectives

9. EuroQol-5D (EQ-5D-5L)

Cognitive Flexibility Scale (CFS)

Cognitive Fusion Questionnaire (CFQ-7)

+9 more

Other study objectives

Blood biomarkers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High DoseExperimental Treatment0 Interventions

High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (38 participants) administered 24hrs prior to first ACT session

Group II: Low DoseActive Control1 Intervention

Low Dose (1mg) PEX010 (Oral Psilocybin), 1mg; single dose (20 participants) administered 24hrs prior to first ACT session

0 / 7Eligibility criteria met

Find a Location

Closest Location:University of Calgary· Calgary, Canada

Who is running the clinical trial?

Vancouver Island UniversityUNKNOWN

1 Previous Clinical Trials

64 Total Patients Enrolled

University of British ColumbiaOTHER

1,504 Previous Clinical Trials

2,528,643 Total Patients Enrolled

University of CalgaryLead Sponsor

825 Previous Clinical Trials

901,510 Total Patients Enrolled

Sandy Shultz, PhDPrincipal InvestigatorDirector, Centre for Trauma and Mental Health Research, Vancouver Island University

Leah Mayo, PhDPrincipal InvestigatorParker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine

2 Previous Clinical Trials

164 Total Patients Enrolled

Pamela Kryskow, MD, CCFPPrincipal InvestigatorMedical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society

Zachary Walsh, PhDPrincipal InvestigatorProfessor, Department of Psychology, University of British Columbia

Paul van Donkelaar, PhDPrincipal InvestigatorProfessor, Faculty of Health and Social Development, School of Health and Exercise Sciences

Shannon Dammes, RN, MPHPrincipal InvestigatorProfessor, Health Sciences, Vancouver Island University, and Visioning and Development Lead, Roots to Thrive Society

Jodie Gawryluk, PhDPrincipal InvestigatorAssociate Professor, Department of Psychology, University of Victoria