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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ketamine-assisted psychotherapy (KAP) is a practical and safe treatment for adults with non-operable gastrointestinal (GI) cancers experiencing existential distress, which involves deep emotional suffering related to life's meaning and purpose. Participants will undergo therapy sessions using ketamine, a medication sometimes used for pain or depression, to assess its impact on their distress. The study aims to determine the safety and tolerability of this therapy for these patients. Individuals with non-operable GI cancers and significant emotional distress might be suitable candidates for this study. As an Early Phase 1 trial, this research seeks to understand how ketamine-assisted psychotherapy works in people, offering participants the chance to contribute to groundbreaking treatment insights.

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.

Is there any evidence suggesting that Ketamine-assisted Psychotherapy is likely to be safe for humans?

Research has shown that ketamine is generally safe in medical settings. Even at higher doses, it maintains a wide safety margin, meaning it remains safe even if slightly overdosed.

In therapy, some individuals might experience side effects like dizziness or mild anxiety, but these effects usually pass quickly. Studies on ketamine-assisted therapy for patients with advanced stomach and intestinal cancers have focused on its safety and found it to be generally safe for these patients.

The FDA has approved ketamine as an anesthetic, a drug that induces unconsciousness for surgery. This approval supports its safety under medical supervision. However, since this trial is in its early phase, researchers continue to gather information on patient tolerance in this specific context. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for gastrointestinal cancer distress involve medications like antidepressants or anti-anxiety drugs, which can take weeks to manifest noticeable effects. Ketamine-assisted psychotherapy (KAP) stands out because it uses ketamine, a fast-acting compound known for its ability to quickly alleviate depressive symptoms. Unlike traditional therapies, KAP combines the therapeutic effects of ketamine with guided psychotherapy sessions, potentially enhancing emotional processing and relief. Researchers are excited because this treatment could provide rapid and more profound relief for patients struggling with the psychological burden of cancer.

What evidence suggests that Ketamine-assisted Psychotherapy might be an effective treatment for gastrointestinal cancer distress?

Research shows that ketamine-assisted psychotherapy (KAP), which participants in this trial will receive, might help people with gastrointestinal cancers by reducing deep emotional distress. Studies have found that combining ketamine with therapy can enhance mental well-being and alleviate pain. Patients who tried KAP reported lasting benefits when therapy sessions occurred before, during, and after ketamine treatment. These early findings offer encouragement for those facing the emotional challenges of advanced cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Benjamin Lewis, MD

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06077487?cond=pancreatic+cancer&aggFilters=status%3A%2Cphase%3A

Ketamine-assisted Therapy for Advanced GI Cancer This study may help researchers learn whether ketamine and talk therapy combined may improve psychosocial distress and pain, as well as decreases opioid ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9207256/

Ketamine Assisted Psychotherapy: A Systematic Narrative ... These findings suggest psychotherapy, provided before, during, and following ketamine sessions, can maximize and prolong benefits.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-07595

Ketamine-assisted Psychotherapy for Improving Existential ... This early phase I trial evaluates the safety and effectiveness of ketamine-assisted psychotherapy for improving existential distress in patients with ...

4. trial.medpath.com trial.medpath.com/clinical-trial/bcde2490da6ab5c3/nct06077487-ketamine-talk-therapy-pancreatic-cancer

Ketamine-assisted Therapy for Advanced GI Cancer | MedPath This study may help researchers learn whether ketamine and talk therapy combined may improve psychosocial distress and pain, as well as decreases opioid ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06077487/ketamine-assisted-therapy-for-advanced-gi-cancer

Ketamine-assisted Therapy for Advanced GI Cancer This study may help researchers learn whether ketamine and talk therapy combined may improve psychosocial distress and pain, as well as ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/87/NCT06077487/Prot_SAP_000.pdf

Pilot study of ketamine-assisted talk therapy for ... To characterize the preliminary safety and tolerability of K-MaP in demoralized patients with stage 3 and 4 GI cancers. 2. To assess the magnitude and ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/016812s043lbl.pdf

KETALAR (ketamine hydrochloride) injection Ketamine has been reported being used as a drug of abuse. Reports suggest that ketamine produces a variety of symptoms including, but not limited to anxiety,.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/016812s039lbl.pdf

Ketalar Label - accessdata.fda.gov Ketamine has a wide margin of safety; several instances of unintentional administration of overdoses of Ketalar (up to ten times that usually required) have ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10225955/

Safety and tolerability of intramuscular and sublingual ... This study reports on adverse effects of intramuscular and sublingual ketamine dosing in a community group psychotherapy setting among 128 participants across ...