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

University of Calgary

Status and phase

Begins enrollment in 5 months

Phase 2

Conditions

Intimate Partner Violence (IPV)

Post Traumatic Stress Disorder PTSD

Treatments

Drug: Psilocybin

Study type

Interventional

Funder types

Other

Identifiers

NCT06885996

REB25-0065

Details and patient eligibility

About

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.

Full 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 (PTSD) symptom burden in 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 (25mg) at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose (1mg) (allocation ratio 1:1) in IPV survivors with chronic PTSD. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (PCL-5 only), and 6 months post-psilocybin administration).

AIM 2: to evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Mean baseline scores will be compared to scores at each follow-up timepoint (1-week, 4 weeks, 3 months (online only), and 6 months post-psilocybin administration).

The secondary efficacy outcomes will include measures of mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life.

Exploratory Aim: Exploratory objectives of this study include evaluating blood biomarkers reflective of inflammation, growth factors, brain injury, and oxidative stress relevant to PTSD and psilocybin's mechanisms of action.

A total of 76 male and female patients between the ages of 18-65 with the last incident of IPV greater than 6 months prior with a score of 1 on the Composite Abuse Scale with repetition of abusive events, meeting DSM-5 criteria for PTSD and a minimum PCL-5 score of 33.

All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (38 participants) or low dose (38 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5-6 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months (online only), and 6 months post-dosing.

Enrollment

76 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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