NCT06001372: TREK

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

Terminated EARLY_PHASE1 Results posted Last updated 16 April 2025

What this trial tests

EARLY_PHASE1 trial testing Ketamine in Gastrointestinal Cancer in 2 participants. Terminated before completion.

Timeline

13 October 2023

Primary endpoint
22 December 2023

12 March 2024

Quick facts

Lead sponsor	University of Utah
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	13 October 2023
Primary completion	22 December 2023
Estimated completion	12 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Ketamine (ketamine) — full drug profile →

Conditions studied

• Gastrointestinal Cancer — all drugs for Gastrointestinal Cancer →
• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →

Sponsor

University of Utah

Who can join

18 and older, any sex, with Gastrointestinal Cancer or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Rate of Study Completion by Enrolled Participants. Study Completion is Defined as Participating in at Least 2 of the 3 Ketamine-Assisted Psychotherapy (KAP) Sessions. Primary · Up to 3 KAP sessions (2 weeks from the initiation of study treatment)

To assess the feasibility of completion of the study intervention. This outcome measure will report the number of participants who reached study completion. Study completion was defined as participating in at least 2/3 of the 3 KAP sessions.

Group	Value	95% CI
Arm 1	2
Arm 1	0

The Severity of Adverse Events (AEs) Secondary · up to 48 days after initiation of the study treatment (30 days after the last dose of study treatment)

This outcome will report the count of AEs and SAEs characterized by severity (as defined by the NIH CTCAE, version 5.0) to assess the safety and tolerability of ketamine-assisted therapy in the study population. All subjects who receive any study treatment will be included in the final summaries and listings of safety data. The severity of the AEs was graded according to the CTCAE v5.0. The CTCAE uses a 5-point grading system to assess the severity of AEs: * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe * Grade 4: Life-threatening * Grade 5: Death This outcome measure will report the c

Toxicity Grade 1

Group	Value	95% CI
Arm 1	1
Arm 1	1

Toxicity Grade 2

Group	Value	95% CI
Arm 1	1
Arm 1	1

Toxicity Grade 3

Group	Value	95% CI
Arm 1	0
Arm 1	2

Toxicity Grade 4

Group	Value	95% CI
Arm 1	0
Arm 1	2

Toxicity Grade 5

Group	Value	95% CI
Arm 1	0
Arm 1	2

To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers. Secondary · Ketamine Session 1 (up to 1 day), Ketamine Session 2 (up to 7 days), Ketamine Session 3 (up to 15 days), Follow-Up Day 14 (up to 29 days), Follow-Up Day 30 (up to 48 days), and Follow-Up Day 90 (up to 100 days).

This outcome will report the proportion of screened patients that meet Existential Distress Scale (EDS) criteria (Single domain score ≥ 3 or Total score ≥ 6). EDS is a 10-item questionnaire for subjects to rank questions about distressing thoughts from 0 to 4 (0 as not distressed, 4 as unbearably distressed). A higher score represents a higher level of Existential Distress. This outcome will report the count of subjects meeting EDS criteria at the following visits Ketamine Session 1, Ketamine Session 2, Ketamine Session 3, Follow-Up Day 14, Follow-Up Day 30, and Follow-Up Day 90.

Ketamine Session 1

Group	Value	95% CI
Arm 1	2
Arm 1	0
Arm 1	0

Ketamine Session 2

Group	Value	95% CI
Arm 1	2
Arm 1	0
Arm 1	0

Ketamine Session 3

Group	Value	95% CI
Arm 1	1
Arm 1	0
Arm 1	1

Follow-Up Day 14

Group	Value	95% CI
Arm 1	0
Arm 1	1
Arm 1	1

Follow-Up Day 30

Group	Value	95% CI
Arm 1	0
Arm 1	1
Arm 1	1

Follow-Up Day 90

Group	Value	95% CI
Arm 1	0
Arm 1	1
Arm 1	1

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs and SAEs were recorded from consent until 30 days after the last dose of study medication or until new cancer therapy was started, up to 48 days after initiation of study treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1

Serious: 1/2 (50%)

Deaths: 0/2

Serious adverse events (1 terms)

Reaction	System	Arm 1
Suicidal ideation	Psychiatric disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Arm 1
Fatigue	General disorders	—

Most-reported serious reactions: Suicidal ideation.

Data from ClinicalTrials.gov NCT06001372 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.