Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS) - Trial NCT06206265

Timeline & Enrollment

Primary Outcome

Incidence of Treatment-Emergent Adverse Events - Hypertension,Incidence of Treatment-Emergent Adverse Events - Abuse-Related Psychological Events,Incidence of Treatment-Emergent Adverse Events - EKG QT Prolongation

Summary

Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical
 disorders will be enrolled in the study.
 
 This study will involve a randomized waitlist control design to investigate the rapid and
 sustained effects of TRP-8802 following two experimental sessions in which an oral dose of
 TRP-8802 is administered to participants with IBS. The study will include clinician and
 participant ratings of depression and anxiety pre- and post-drug-session, monitor and
 participant ratings of subjective drug effects during and after each drug session.
 
 This study comprises approximately a 28-day screening period (Days 28 to 1). After screening
 and enrollment, participants will be randomized to an immediate treatment group or a delayed
 treatment group (waitlist control condition).
 
 Participants in the immediate treatment group will proceed directly into three weeks of
 baseline and preparation (Days 1 to 18), a 2-dose administration period (Days 22 and 37),
 integration (Days 23, 30, 38, and 45), the End of Therapy (EOT) visit (Day 52). Participants
 in the delayed treatment group will wait 8 weeks after enrollment before beginning the study
 interventions and neuroimaging assessments. As a safety precaution, participants in the
 delayed treatment group will be assessed weekly via telephone calls or in-person visits
 during the wait period (i.e., telephone assessments during post-randomization weeks 1, 2, 3,
 4, 5, 6, and 7; in-person assessment during post-randomization week 8) to assess suicide risk
 to determine if intervention is warranted. During week 8, IBS symptoms will also be assessed.
 At the end of the delay period, all participants in the delayed treatment group will complete
 the same intervention as the participants in the immediate treatment group.
 
 Validated and commonly used assessment tools will be used to evaluate symptoms at baseline
 and repeatedly after each session. The weekly average of worst daily pain score and weekly
 stool frequency and consistency for the 7 days immediately prior to EOT visit will be
 assessed for change from baseline and at the 3-, 6 , and 12- month follow-up visits (Days
 120, 240, 365).

ICD-10 Classifications