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Ketamine + Talk Therapy for Pancreatic Cancer

Phase 4

Waitlist Available

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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 49 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of participant responses to intervention acceptability

Proportion eligible versus screened participants.

Proportion of participants who complete therapy

Secondary outcome measures

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

Mean scores on the Brief-Pain Inventory Short Form (BPI-SF) over time

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B (K-Map)Experimental Treatment4 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 ketamine administration (Day 0), and twice afterward. 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 Treatment3 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 ketamine administration (Day 0), and twice afterward. 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

~1090

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brian Anderson, MDLead Sponsor

Brian T Anderson, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree could exposure to Group A (K-MaP) be detrimental to participants?

"The safety of Group A's (K-MaP) treatment was rated a 3, due to the fact that it has reached Phase 4 of clinical trials and is officially approved for use."

Answered by AI

Are there any participating opportunities in this trial at present?

"The digital records on clinicaltrials.gov suggest that this medical research is no longer recruiting patients, as the last modification to its profile was made on October 5th 2023. However, there are over 970 different studies currently looking for volunteers."

Answered by AI

What aims is the research hoping to achieve?

"This clinical trial will span a duration of up to 28 days, during which time the main objective will be tracking how many patients complete their therapy. Secondary objectives include calculating any clinically significant changes in blood pressure and heart rate from pre-medication administration to end of study visit, as well as recording mean scores on the Challenging Experience Questionnaire (CEQ) over time. The CEQ comprises 26 items that are scored on a 5-point Likert scale ranging from "None; not at all" to "Extreme [more than ever before in my life]"."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketamine-assisted Therapy for Patients With Pancreatic Ductal Adenocarcinoma

Brian Anderson, MD 2024. "Ketamine-assisted Therapy for Patients With Pancreatic Ductal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077487.

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