Group Psilocybin-Assisted Therapy for... — Clinical Trial Details

This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.

Participants

Ages

18 – 89

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

General:
T+H years of age and \<89 years of age
Identify as a member of one of the cohorts to be studied:
Veteran or first responder
Female survivor of sexual violence
Indigenous person
Not pregnant, planning to become pregnant, or breastfeeding; if able to become pregnant, willing to use reliable form of birth control for the duration of the study
If needed, ability and willingness to taper and discontinue medications that may interfere with the action of psilocybin
Ability to read, speak, and understand English
Ability and willingness to consent to the terms of the study, including attending all trial visits (most of which will occur in a group setting), preparation and
follow-up sessions, and completing all trial evaluations
Ability and willingness to swallow capsules
PTSD severity:
Meet criteria for PTSD, as defined in the DSM-5
At screening, symptoms of moderate to severe PTSD (PCL-5 score of 34 or greater) present for at least six months

Exclusion Criteria

Inability to achieve five days of abstinence from alcohol, non-prescribed opioids, methamphetamines, cocaine, benzodiazepines, or other illicit substances
Inability or unwillingness to remain abstinent from cannabis use for 24 hours prior to psilocybin dosing session and 12 hours after receiving the dose of psilocybin
Risk for clinically significant acute withdrawal from any substance that would cause safety concern on the day of dosing
Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests: Pregnancy/breastfeeding
Cardiovascular conditions:
Uncontrolled hypertension, defined as \>140/90 mm Hg at screening or baseline or \>145/95 mm Hg on presentation for dosing day assessed on three consecutive blood pressure measurements
History of myocardial infarction, cardiac ischemia, congestive heart failure, clinically relevant valvular heart disease, or pulmonary hypertension; any other significant history of cardiovascular condition, based on the clinical judgment of the Trial Physician, which would make a participant unsuitable for the trial
ECG: Clinically significant abnormality (e.g. atrial fibrillation based on judgement of trial physician including prolonged corrected QT interval (QTc\> 450 milliseconds (males) or \>470 milliseconds (females)
Poorly controlled diabetes (HbA1c \>8.0%; clinically significant hypoglycemia in the past 6 months)
Neurological conditions (e.g. epilepsy or other seizure disorder) or neurodegenerative disease (e.g., dementia, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis.), or brain tumor that would impact participation in the trial Serious abnormalities of complete blood count or chemistry
* Severe hepatic impairment
* Severe renal impairment,
* Unstable existing thyroid disorder
Any of the following psychiatric conditions:
* Active suicidal ideation; history of hospitalization for suicide attempt within the 12 months prior to screening, affirmative responses to C-SSRS questions 4 or 5
* Confirmed diagnosis of schizophrenia or other psychotic disorder, firstdegree relative with schizophrenia
* Axis-II diagnosis
Use of psychedelics (e.g., psilocybin, mescaline, ayahuasca, DMT, LSD, MDMA, or ketamine) resulting in a discrete psychedelic experience in the past six months.
Using daily dose of psilocybin mushrooms at dose \<0.2 mg or LSD at \<20 mcg per day for \<30 days in a year ("microdosing") will not be an exclusion criterion.
However, participants must agree to no further use of psychedelics during this study starting at screening.
Returning to an unsafe environment and/or inadequate social support-Any other condition, physical or psychological symptom, medication, or other relevant finding prior to randomization that, based on the clinical judgment of trial personnel, would make a participant unsuitable for the trial.-

Company

Product

Legal

Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

Detailed Description

Study Protocol

Preparation

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

GPAT-PTSD

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators