Trial Title:
Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers
NCT ID:
NCT06001372
Condition:
Gastrointestinal Cancer
Depression
Anxiety
Conditions: Official terms:
Gastrointestinal Neoplasms
Ketamine
Conditions: Keywords:
Ketamine Assisted Therapy
Existential Distress
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single group, open label pilot study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ketamine
Description:
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)
Arm group label:
Arm 1
Other name:
Ketamine Assisted Psychotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- 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.)
Exclusion Criteria:
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84108
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin Lewis, MD
Phone:
435-655-5128
Email:
ben.lewis@hsc.utah.edu
Investigator:
Last name:
Benjamin Lewis, MD
Email:
Principal Investigator
Start date:
October 13, 2023
Completion date:
November 15, 2025
Lead sponsor:
Agency:
University of Utah
Agency class:
Other
Source:
University of Utah
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001372
