Gastrointestinal CancerEarly Phase 1TREKNCT06001372
Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers
A Early Phase 1 study testing Ketamine in people with Gastrointestinal Cancer and Depression, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Depression, Anxiety
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2023to 12 Mar 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago; or
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Participants of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
- Participants with a sexual partner of childbearing potential must agree to use a condom during intercourse for 24 hours post- ketamine dose.
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages, ondansetron, cannabis, and non-routine PRN medications within 24 hours of each ketamine administration. Exceptions include daily use of caffeine, nicotine, and opioid pain medication
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Agree that for one week preceding the ketamine session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- Agree not to use nicotine for at least 2 hours before the ketamine administration or for the duration of the ketamine session.
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the ketamine session. If the participant does not routinely consume caffeinated beverages, he or she must agree not to do so on the day of ketamine administration.
- Participants requiring opioid use for pain are on a stable pain management regimen or do not experience clinically significant sedation during opioid use. Note: Long-acting opioid medications (e.g., oxycodone sustained-release, morphine sustained release) will be allowed if the last dose occurred at least 6 hours before ketamine administration; such medication will not be taken again until at least 6 hours after ketamine administration.
- Fluent in English.
- Reading literacy and comprehension sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
- Have a support person who is be able to escort the participant home from the ketamine dosing sessions. Note: The use of ride services will not be permitted (e.g., Uber, Lift, taxi, etc.)
Who cannot join
- 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
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- 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.
- Uncontrolled hypertension defined as ≥ 140/90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.
- Seizure disorder
- Moderate to severe dementia
- History of significant traumatic brain injury
- Requires the use of supplemental oxygen.
- Renal insufficiency as defined as creatinine clearance < 40 mL/min calculated by Cockcroft-Gault formula
- Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [participants may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Participants on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C. Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- Known prior severe hypersensitivity to ketamine or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
- Participants taking prohibited medications as described in Section 6.5.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84108
About this study
Official title: TREK: Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers
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
- Being tested
- Ketamine
- Keywords
- Ketamine Assisted Therapy, Existential Distress
- Medical subject headings
- Gastrointestinal Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine Assisted Psychotherapy
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 KAP sessions (2 weeks from the initiation of study treatment)
Secondary outcomes (2)
The Severity of Adverse Events (AEs)
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 count of participants who experienced an AE or SAE at each toxicity grade. Adverse events were followed until 14 days after the last dose of study treatment.
Measured: 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.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start13 Oct 2023
- Primary completion22 Dec 2023
- Study completion12 Mar 2024
Why it stopped: Challenges with feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open label pilot study
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Lewis, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001372
- Sponsor's protocol ID
- HCI160227
- Acronym
- TREK
- Status last verified
- Apr 2025
- First submitted
- 4 Aug 2023
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREK: Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers
- ClinicalTrials.gov ID
- NCT06001372
- Acronym / sponsor ID
- TREK / HCI160227
- Conditions
- Gastrointestinal Cancer, Depression, Anxiety
- Keywords
- Ketamine Assisted Therapy, Existential Distress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges with feasibility
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open label pilot study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: KetamineThree 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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:
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketamine Assisted PsychotherapyKetamine, 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) | Drug | Arm 1 |
Primary outcome
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.
Time frame: 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.
2 secondary outcomes
The Severity of Adverse Events (AEs)
Time frame: 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.
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Lewis, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine in people with Gastrointestinal Cancer and Depression, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 3 KAP sessions (2 weeks from the initiation of study treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.