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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 belowSelect...
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:Select...
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
Brian Anderson, MDLead Sponsor
Brian T Anderson, MDPrincipal InvestigatorUniversity of California, San Francisco