Psilocybin-Assisted Psychotherapy in Treating... — Clinical Trial Details

Participants

Ages

18 – 75

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
Severe IBS patients meeting Rome IV criteria. Severe IBS is defined by IBS-SS >300, or one or more emergency room (ER) visit for abdominal pain in the last year.
Experiencing persistent IBS symptoms despite pharmacologic therapy
Have an identified support person
Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.
Participants must agree to send outside medical records in order for the study team to verify eligibility.

Exclusion Criteria

Exclusion Criteria:
Unstable medical conditions or serious abnormalities on complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial (examples include congestive heart failure; clinically significant arrhythmias or ECG abnormality such as corrected QT interval > 450; recent acute myocardial infarction or evidence of ischemia in the last year; malignant hypertension; congenital long QT syndrome; history of valvular heart disease; acute renal failure; moderate to severe hepatic impairment [Child Pugh class B and C]; respiratory failure; recent stroke < 1 year; laboratory abnormalities such as ALT ≥ 2X ULN, AST ≥ 2X ULN, hemoglobin <11.5, platelets <150, WBC >10, sodium >150, potassium <3.5 or >5.2).
Abnormal and clinically significant results on physical examination (BP >139/89 mmHg), heart rate >90 bpm, history of pulmonary hypertension
Significant central nervous system pathology (e.g., primary or secondary cerebral neoplasm, epilepsy, history of stroke, cerebral aneurysm, dementia, delirium)
Primary psychotic or affective psychotic disorders (e.g., schizophrenia spectrum, schizoaffective disorder, bipolar I or II with psychotic features, substance-induced psychotic disorders, paranoid or delusional disorders, other psychotic illnesses)
Family history of psychotic or serious bipolar spectrum illnesses (first-degree relative with schizophrenia spectrum disorder, schizoaffective disorder, bipolar I with psychotic features, or other psychotic illness)
High risk of adverse emotional or behavioral reaction based on investigator assessment (examples: agitation, violent behaviour)
Active substance use disorders (DSM-5 criteria for moderate or severe alcohol or drug use disorder within the past year; excludes caffeine and nicotine)
Clinically significant suicidality or high risk of completed suicide as defined in protocol (see suicidality details)
History of hallucinogen persisting perception disorder (HPPD)
Pregnancy or lactation
Cognitive impairment (MoCA < 23)
Concurrent medications: antidepressants; centrally-acting serotonergic agents (e.g., MAOIs); antipsychotics; mood stabilizers (e.g., lithium, valproic acid); aldehyde dehydrogenase inhibitors (e.g., disulfiram); significant inhibitors of UGT1A0 or UGT1A10; niacin
Subjects should not be taking serotonin-acting dietary supplements (e.g., 5-HTP, St. John's wort)
Positive urine drug test for listed substances (amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, methamphetamine, MDMA, methadone, opiates, PCP)
Psychiatric condition incompatible with establishment of rapport with therapists or safe exposure to psilocybin
Any psychological or physical symptom, medication or other finding prior to randomization that would make participant unsuitable per PI judgment
Allergy or intolerance to psilocybin or niacin
Enrolment in another clinical trial assessing interventions for anxiety, depression, or existential distress
Unable or unwilling to provide external medical records

Company

Product

Legal

Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin + PAP

Interventions

Niacin + PAP

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators