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

Launched by UNIVERSITY OF CALGARY · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called psilocybin, combined with a type of therapy known as Acceptance and Commitment Therapy (ACT), to help reduce symptoms of Post-Traumatic Stress Disorder (PTSD) in adults who have experienced intimate partner violence (IPV). Researchers want to see if a specific dose of psilocybin can improve PTSD symptoms and overall quality of life for participants. The study aims to compare how well this treatment works against a lower dose of psilocybin and to check improvements in mood, thinking skills, and daily functioning.

To participate, individuals must be aged 19 to 65, have experienced IPV at least six months ago, and have a certain level of PTSD symptoms. They will go through a screening process and attend several sessions, including therapy and psilocybin administration. Participants will also complete questionnaires to track their progress over several months. It’s important to note that individuals with certain mental health conditions, substance use disorders, or other medical issues may not be eligible for this study.

Gender

ALL

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