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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Psilocybin

Treatment groups

76 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Calgary

Lead sponsor

Vancouver Island University

Collaborator

University of British Columbia

Collaborator