Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers

This open-label clinical trial (n=12) aims to assess the feasibility of ketamine-assisted psychotherapy (KAP) for adults with non-operable gastrointestinal (GI) cancers suffering from existential distress.

Conducted by the University of Utah, the study seeks to determine the safety and tolerability of KAP in this population and to gauge the prevalence of existential distress among them. Participants will receive KAP as standard care at the HMHI Park City Ketamine-Assisted Psychotherapy Clinic.

The primary outcome measure is the rate of study completion by enrolled participants, defined as participating in at least 2 of the 3 KAP sessions, over a one-year period. Secondary outcome measures include assessing the safety and tolerability of KAP through the frequency of adverse events and serious adverse events and determining the prevalence of existential distress using the Existential Distress Scale.

The study began on October 13, 2023, and is expected to conclude on November 15, 2025.

Topic Anxiety
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 13 October 2023
End date 15 November 2025
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 11
Sex All
Age 18- 99
Therapy Yes

Trial Details

The goal of this open-label clinical trial is to assess the feasibility of Ketamine-assisted psychotherapy (KAP) studies for adults with non-operable GI cancers suffering with existential distress. The main questions it aims to answer are: - Is it feasible to conduct a KAP study with this population? - What is the safety and tolerability of KAP in this population? - How prevalent is existential distress in this population? Participants will undergo KAP administered as standard of care at the HMHI Park City Ketamine-Assisted Psychotherapy Clinic and will complete health assessments over the course of the study, as well as during the therapy.

NCT Number NCT06001372

Sponsors & Collaborators

University of Utah
Research with psychedelics is underway at the University of Utah. At the university, researchers are working with the Usona Institute exploring psilocybin-assisted group therapy in patients with cancer.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.