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Ketamine + Talk Therapy for Pancreatic Cancer

Phase 4

Recruiting

Led By Brian T Anderson, MD

Research Sponsored by Brian Anderson, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be able to swallow liquid oral medication

Must have a Palliative Performance Score (PPS) v. 2.0 greater than or equal to 40%

Must not have

Has had a stroke (embolic) within 12 months of signing ICF

Has a history of intracranial hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 49 days

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests if ketamine & talk therapy can reduce pain, anxiety & demoralization in PDAC patients taking opioids for cancer-related pain.

Who is the study for?

This trial is for adults with pancreatic ductal adenocarcinoma who experience significant distress and pain, despite opioid use. Participants must be willing to follow study procedures, speak English/Spanish, avoid certain substances like caffeine and alcohol, and maintain their usual opioid regimen. They should not have had recent severe cardiovascular issues or other specific health conditions that could interfere with the study.

What is being tested?

The trial tests if a single dose of oral ketamine combined with talk therapy can reduce demoralization in patients suffering from pancreatic cancer-related pain. It aims to see if this approach lessens psychological distress and decreases reliance on opioids for managing pain.

What are the potential side effects?

Ketamine may cause side effects such as changes in blood pressure, disorientation or confusion (dissociation), nausea, dizziness, blurred vision, dry mouth or an increase in heart rate. Talk therapy typically does not have physical side effects but can sometimes bring up uncomfortable emotions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow liquid medicine.

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I can care for myself but may need help with daily activities.

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I have been diagnosed with pancreatic cancer.

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I am 18 years old or older.

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I can stop taking my antipsychotics, anxiety meds, dopamine drugs, and lithium for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stroke within the last year.

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I have had bleeding in my brain before.

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I have a severe neurological condition that increases my risk of psychosis.

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I am currently undergoing ECT, TMS, or similar treatments.

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I have a history of aneurysms or abnormal blood vessel connections.

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I have a serious irregular heartbeat.

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I have heart failure that affects my daily activities.

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I have trouble swallowing or a condition that increases my risk of choking.

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I need extra oxygen sometimes or all the time.

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I am currently experiencing uncontrollable nausea, vomiting, or diarrhea.

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I have had a brain bleed in the past.

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I have difficulty thinking or remembering that makes it hard for me to follow study procedures.

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I have been diagnosed with moderate or severe lung blood pressure.

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I have a tumor in my brain.

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I have a severe heart valve problem.

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I experience heart-related symptoms like chest pain or fainting with exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 49 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 49 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 49 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of participant responses to intervention acceptability

Proportion eligible versus screened participants.

Proportion of participants who complete therapy

Secondary study objectives

Mean clinician-rated scores on the Demoralization Interview (DI) over time

Mean clinician-rated scores on the GRID-Hamilton Depression Rating Scale (GRID-HAMD) over time

Mean clinician-rated scores on the Global Clinical impression of severity (CGI-S) over time

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B (K-Map)Experimental Treatment5 Interventions

Participants will receive 0.5mg/kg of Ketamine IM with a placebo oral solution on Day 0/Visit 4 and receive Meaning and Purpose (MaP) therapy 4 times, twice before (between days -13 and -1) ketamine administration, and twice afterward on days 3 (+/- 2 days) and 11 (+/- 3 days). The duration of treatment for ketamine plus MaP (K-MaP) therapy is approximately up to 28 days. Participants will be followed up to 35 days (+/-2 days) after ketamine administration.

Group II: Group A (K-MaP)Experimental Treatment4 Interventions

Participants will receive 0.5mg/kg of Ketamine orally with an equivalent quantity of placebo via an intramuscular injection on Day 0/Visit 4 and receive Meaning and Purpose (MaP) therapy 4 times, twice before (between days -13 and -1) ketamine administration, and twice afterward on days 3 (+/- 2 days) and 11 (+/- 3 days). The duration of treatment for ketamine plus MaP (K-MaP) therapy is approximately up to 28 days. Participants will be followed up to 35 days (+/-2 days) after ketamine administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine Injectable Product

2020

Completed Phase 1

~20

Ketamine

2011

Completed Phase 4

~1120