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

PHASE2RecruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

January 17, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2026

Conditions
Irritable Bowel Syndrome
Interventions
DRUG

TRYP-0082

Participants will receive one dose of 25 mg of oral psilocybin on the first dosing day and a second dose of 25mg oral psilocybin on the second dosing day. TRP 8802 will be administered in a comfortable setting under the guidance of the same two therapists from the preparation period. Participants will have an in-person study visit following the resolution of the psychoactive effects of the psilocybin (as determined by the therapists in discussion with the participant) to ensure participant's safety and comfort.

BEHAVIORAL

Psychotherapy

Participants will receive one dose of 25 mg of oral psilocybin on the first dosing day and a second dose of 25mg oral psilocybin on the second dosing day. TRP 8802 will be administered in a comfortable setting under the guidance of the same two therapists from the preparation period. Participants will have an in-person study visit following the resolution of the psychoactive effects of the psilocybin (as determined by the therapists in discussion with the participant) to ensure participant's safety and comfort.

Trial Locations (1)

02114

RECRUITING

Massachusetts General Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

TRYP Therapeutics

INDUSTRY

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