Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers (TREK)
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ClinicalTrials.gov Identifier: NCT06001372 |
Recruitment Status :
Recruiting
First Posted : August 21, 2023
Last Update Posted : March 15, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | August 4, 2023 | ||||||
First Posted Date ICMJE | August 21, 2023 | ||||||
Last Update Posted Date | March 15, 2024 | ||||||
Actual Study Start Date ICMJE | October 13, 2023 | ||||||
Estimated Primary Completion Date | November 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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: One year ] To assess the feasibility of completion of the study intervention by 12 participants.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers | ||||||
Official Title ICMJE | TREK: Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers | ||||||
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:
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. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Early Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single group, open label pilot study Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Ketamine
Ketamine, 0.5-1.2mg/kg, administered intramuscularly
Other Name: Ketamine Assisted Psychotherapy
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Study Arms ICMJE | Experimental: Arm 1
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Intervention: Drug: Ketamine
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
12 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | November 15, 2025 | ||||||
Estimated Primary Completion Date | November 15, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT06001372 | ||||||
Other Study ID Numbers ICMJE | HCI160227 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University of Utah | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | University of Utah | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of Utah | ||||||
Verification Date | March 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |