psilocybin-assisted therapy for post-traumatic stress disorder in survivors of intimate partner violence

Conditions: Post Traumatic Stress Disorder PTSD; Intimate Partner Violence (IPV)

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.

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.

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

Keywords: psychotherapy psilocybin acceptance and commitment therapy