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Behavioural Intervention
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
TREK Trial 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.Check my eligibility
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.See study design
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.
TREK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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).
TREK Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090
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Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,677 Total Patients Enrolled
Benjamin Lewis, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period of this investigation still open?
"As noted on the clinicaltrials.gov website, this trial is not presently recruiting participants as it was last updated August 14th 2023. Despite that, there are still over 1,500 other medical studies currently open for enrollment."
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