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

NCT06001372 | Terminated Early Phase 1 Results DMC FDA Drug

• 1 other identifier: HCI160227
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ketamine Assisted Therapy; Existential Distress

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Up to 3 KAP sessions (2 weeks from the initiation of study treatment)

Secondary Outcomes (2)

• The Severity of Adverse Events (AEs)

  up to 48 days after initiation of the study treatment (30 days after the last dose of study treatment)

• To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.

  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).

Study Arms (1)

Arm 1

EXPERIMENTAL

Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart

Drug: Ketamine

Interventions

Ketamine DRUG

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)

Also known as: Ketamine Assisted Psychotherapy

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant aged ≥ 18 years.
• Participant with non-operable GI cancers requiring multi-modal treatment (e.g. surgery +/- chemo +/-radiation) and have a a high likelihood of recurrence and/or treatment failure in the opinion of the treating investigator.
• Screen positivity for existential distress on the EDS, defined as scoring ≥ 3 on any of the 10 component domains, or a total score ≥ 6
• ECOG Performance Status ≤ 2.
• Adequate hepatic function as defined as:
• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless elevated bilirubin is related to Gilbert's Syndrome
• AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
• Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
• For participants of childbearing potential: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
• Participants \< 50 years of age:
• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
• Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
• Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
• Participants ≥ 50 years of age:
• Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or

You may not qualify if:

• Received ketamine treatments for a psychiatric condition within 6 months of enrollment.
• Personal history or first- or second-degree relatives with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness.
• Currently meeting DSM-5 criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to ketamine.
• Currently meeting DSM-5 criteria for Cluster B Personality Disorder.
• Severe depression requiring immediate standard-of-care treatment (e.g., hospitalization).
• Suicidal ideation over the past month as assessed as a yes to question 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale, Suicidal Ideation section
• Cancer with known CNS involvement, previously treated brain metastasis, or other major CNS disease.
• Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine). Current substance use disorders may be identified through the drug urine screening test.
• Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
• Cardiovascular disorders:
• Any grade congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias including tachycardia, or clinically significant screening ECG abnormalities.
• Cardiac hypertrophy or artificial heart valve.
• Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism), and/or significant coronary artery disease within 3 months before the first dose.
• QTc prolongation defined as a QTcF \> 450 ms.
• Known congenital long QT.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Depression; Anxiety Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: IIT Data Management Team
• Organization: Research Compliance Office, Huntsman Cancer Institute

IITDataManagement@hci.utah.edu

801-213-6215

Study Officials

• Benjamin Lewis, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, open label pilot study

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 21, 2023
• Study Start: October 13, 2023
• Primary Completion: December 22, 2023
• Study Completion: March 12, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)