Status:
NOT_YET_RECRUITING
Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Vancouver Island University
University of British Columbia
Conditions:
Post Traumatic Stress Disorder PTSD
Intimate Partner Violence (IPV)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 diso...
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 (PTS...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06885996
Start Date
August 1 2026
End Date
August 1 2029
Last Update
January 6 2026
Active Locations (3)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
2
The University of British Columbia - Okanagan Campus
Kelowna, British Columbia, Canada, V1V 1V7
3
Vancouver Island University
Nanaimo, British Columbia, Canada, V9R 5S5