NCT06001372

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

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastrointestinal Cancer
• Depression
• Anxiety

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine, 0.5-1.2mg/kg, administered intramuscularly * Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg. * Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement. * Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)

Timeline

• Start date: 2023-10-13
• Primary completion: 2023-12-22
• Completion: 2024-03-12
• First posted: 2023-08-21
• Last updated: 2025-04-16
• Results posted: 2025-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study