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

NCT06001372 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-04-16

Study results available
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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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Benjamin Lewis, MD · Huntsman Cancer Institute/ University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-13
Primary Completion
2023-12-22
Completion
2024-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06001372 on ClinicalTrials.gov