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Not yet recruitingPhase 2

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

NCT06885996 · PsiPTSD · University of Calgary

Closed to entry
Status
Not accepting participants
Phase 2
Phase
76
Target enrolment
2
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

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

  • PTSD Checklist for DSM-5 (PCL-5)

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

2 study sites

FacilityCityRegionCountry
University of CalgaryCalgaryAlbertaCanada
The University of British Columbia - Okanagan CampusKelownaBritish ColumbiaCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06885996 on ClinicalTrials.gov →

Last updated in the registry 2026-05-14. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits