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

NCT06885996 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: REB25-0065
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

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.

Conditions

Post Traumatic Stress Disorder PTSD; Intimate Partner Violence (IPV)

Keywords

Psychotherapy; Psilocybin; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (2)

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

  A clinician-administered, 30-item structured interview to diagnose and assess severity of PTSD symptoms in patients. It is widely used and validated, and is considered the gold standard PTSD diagnostic tool.

  Change from baseline to 1-week, 4 weeks, and 6 months post-dosing

• PTSD Checklist for DSM-5 (PCL-5)

  A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.

  Change from baseline to 1-week, 4 weeks, and 3 months, and 6 months post-dosing

Secondary Outcomes (12)

• 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

Other Outcomes (1)

• Blood biomarkers

  Change from baseline to 1-week, 4 weeks, and 6 months post-dosing

Study Arms (2)

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

Drug: Psilocybin

Interventions

Psilocybin DRUG

See treatment arm description.

Low Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Vancouver Island University: collaborator
• University of British Columbia: collaborator

Study Sites (3)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

The University of British Columbia - Okanagan Campus

Kelowna, British Columbia, V1V 1V7, Canada

Location

Vancouver Island University

Nanaimo, British Columbia, V9R 5S5, Canada

Location

MeSH Terms

Conditions

Combat Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Sandy Shultz, PhD

  Director, Centre for Trauma and Mental Health Research, Vancouver Island University

  PRINCIPAL INVESTIGATOR

• Leah Mayo, PhD

  Parker Psychedelics Research Chair and Assistant Professor, Department of Psychiatry, University of Calgary, Cumming School of Medicine

  PRINCIPAL INVESTIGATOR

• Pamela Kryskow, MD, CCFP

  Medical Lead, Psychedelic-assisted Therapy Graduate Program, Vancouver Island University, Medical Director, Roots to Thrive Society

  PRINCIPAL INVESTIGATOR

• Zachary Walsh, PhD

  Professor, Department of Psychology, University of British Columbia

  PRINCIPAL INVESTIGATOR

• Paul van Donkelaar, PhD

  Professor, Faculty of Health and Social Development, School of Health and Exercise Sciences

  PRINCIPAL INVESTIGATOR

• Shannon Dammes, RN, MPH

  Professor, Health Sciences, Vancouver Island University, and Visioning and Development Lead, Roots to Thrive Society

  PRINCIPAL INVESTIGATOR

• Jodie Gawryluk, PhD

  Associate Professor, Department of Psychology, University of Victoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantel T Debert, MD MSc FRCPC

CONTACT

403) 944-4500; cdebert@ucalgary.ca

Christina Campbell, MSc

CONTACT

403-944-8649; christina.campbel1@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group assignments to active (high dose) and control (low dose) psilocybin-assisted therapy will be based on a blocked randomization list (10 participants per block) using sealed envelopes created by an employee of the University of Calgary, who will not be involved in the conduct, or the analysis of the study. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized controlled trial

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: January 6, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)