Ketamine-assisted Psychotherapy for Gastrointestinal Cancer Distress

(TREK Trial)

Overseen By Susan Sharry

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

Must not be taking: Psychoactive drugs, Ondansetron

Disqualifiers: Schizophrenia, Bipolar, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2-3 weeks

2 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to stop using any psychoactive drugs, including alcohol, cannabis, and certain non-routine medications, within 24 hours of each ketamine session. Additionally, participants must refrain from taking nonprescription medications, nutritional supplements, or herbal supplements for one week before the ketamine session, unless approved by the research team. There is also a washout period for prohibited medications, which should last at least five half-lives or as clinically indicated before starting treatment.

How is Ketamine-assisted Psychotherapy different from other treatments for gastrointestinal cancer distress?

Ketamine-assisted Psychotherapy (KAP) is unique because it combines the psychedelic effects of ketamine with psychotherapy to address emotional distress, unlike traditional treatments that may not use psychedelics. This approach leverages ketamine's rapid-acting antidepressant properties and its ability to enhance therapeutic engagement, potentially offering faster relief from distress. ^{1 2 3 4 5}

Research Team

Benjamin Lewis, MD

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

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.

Inclusion Criteria

I agree not to use nicotine 2 hours before and during the ketamine session.

Participants with a sexual partner of childbearing potential must agree to use a condom during intercourse for 24 hours post-ketamine dose

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

Exclusion Criteria

I or my close family have a history of certain mental health conditions.

My cancer has spread to my brain or I have a major brain condition.

I need immediate treatment for severe depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart

2-3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ketamine-assisted Psychotherapy (KAP)

Trial Overview 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.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart

Ketamine-assisted Psychotherapy (KAP) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Pain management
• Depression (off-label)
• Existential distress (investigational)

Approved in European Union as Ketanest for:

• Anesthesia
• Pain management

Approved in Canada as Ketamine for:

• Anesthesia
• Pain management
• Depression (off-label)

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

Ketamine Assisted Psychotherapy (KAP) is an effective treatment for reducing depression and anxiety, particularly in older patients and those with severe symptoms, based on data from 235 patients.

Unlike traditional intravenous ketamine treatments that view its psychedelic effects as side effects, KAP utilizes these effects in a therapeutic context, making it suitable for office and supervised at-home use due to ketamine's proven safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. Dore, J., Turnipseed, B., Dwyer, S., et al.[2020]

Ketamine-assisted psychotherapy (KAP) shows promise as a treatment for adolescents with various mental health disorders, with four cases demonstrating symptomatic and functional improvements after treatment.

The treatment was well-tolerated, and family involvement was highlighted as crucial for success, suggesting that KAP could significantly enhance the options available for adolescent psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine-assisted psychotherapy in adolescents with multiple psychiatric diagnoses. Wolfson, PE., Andries, J., Ahlers, D., et al.[2023]

A systematic review of 19 studies involving 1006 patients found that combining psychotherapy with ketamine treatment for psychiatric disorders generally leads to positive outcomes, particularly for conditions like substance use disorders and treatment-resistant depression.

Despite the promising results, the significant variability in psychotherapy types and ketamine protocols across studies means that more standardized and larger randomized controlled trials are needed to determine the best ways to integrate these treatments effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine and psychotherapy for the treatment of psychiatric disorders: systematic review. Kew, BM., Porter, RJ., Douglas, KM., et al.[2023]

In a study involving five participants with eating disorders and comorbid mood and anxiety disorders, weekly group-based ketamine-assisted psychotherapy (G-KAP) over 4 weeks led to significant improvements in depression and anxiety symptoms for most participants, with four showing notable reductions in depression scores and two in anxiety scores.

The ketamine treatment was well tolerated with no serious adverse events reported, indicating its safety and feasibility as an adjunct therapy in intensive residential eating disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of group-based ketamine-assisted psychotherapy for patients in residential treatment for eating disorders with comorbid depression and anxiety disorders. Robison, R., Lafrance, A., Brendle, M., et al.[2022]

A systematic review of 17 articles involving 603 participants indicates that ketamine-assisted psychotherapy (KAP) can lead to significant reductions in pain, anxiety, and depressive symptoms, while also enhancing patient engagement and promoting abstinence in substance use disorders.

The review highlights that the effectiveness of KAP varies based on factors like ketamine administration route and psychotherapy type, suggesting that tailored approaches can maximize and prolong treatment benefits, but further large-scale studies are needed to standardize practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Assisted Psychotherapy: A Systematic Narrative Review of the Literature. Drozdz, SJ., Goel, A., McGarr, MW., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Ketamine-assisted psychotherapy in adolescents with multiple psychiatric diagnoses. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Ketamine and psychotherapy for the treatment of psychiatric disorders: systematic review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A case series of group-based ketamine-assisted psychotherapy for patients in residential treatment for eating disorders with comorbid depression and anxiety disorders. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Ketamine Assisted Psychotherapy: A Systematic Narrative Review of the Literature. [2022]