Ketamine-assisted Psychotherapy for Gastrointestinal Cancer Distress (TREK Trial)

Phase < 1

Recruiting

Led By Benjamin Lewis, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses if Ketamine-assisted psychotherapy is safe & feasible for adults suffering from existential distress due to a non-operable GI cancer. Participants will complete health assessments during the therapy.

Who is the study for?

This trial is for adults over 18 with non-operable GI cancers and existential distress. They must be fluent in English, on a stable pain regimen if using opioids, have good liver function, not use psychoactive drugs or alcohol before sessions, and can't be pregnant or breastfeeding. Participants need to agree to contraception use and have someone to take them home post-session.

What is being tested?

The study tests Ketamine-assisted Psychotherapy (KAP) for safety, tolerability, and feasibility in treating existential distress among patients with gastrointestinal cancers that cannot be surgically removed. It involves health assessments and therapy at the HMHI Park City Clinic.

What are the potential side effects?

While specific side effects are not listed here, ketamine can generally cause disorientation, dizziness, nausea, increased blood pressure and heart rate during administration. Long-term side effects may include memory issues or bladder problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.

The proportion of screened patients that meet criteria on the Existential Distress Scale (EDS: Single domain ≥ 3 or total score ≥ 6).