Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077487
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-10-05
Brief Title:
Ketamine-assisted Therapy for Patients With Pancreatic Ductal Adenocarcinoma
Sponsor:
Brian Anderson MD
Organization:
University of California San Francisco
Study Overview
Official Title:
Pilot Study of Ketamine-assisted Talk Therapy for Demoralization in Patients With Pancreatic Ductal Adenocarcinoma and Pain
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates whether it is possible to use a single dose of ketamine in combination with talk therapy to treat moderate to severe demoralization in patients with pancreatic ductal adenocarcinoma PDAC who take opioids for cancer-related pain PDAC patients often suffer from high rates of psychosocial distress and pain Symptoms of anxiety are highly prevalent among PDAC patients While opioid analgesia pain reliever succeeds in managing some symptoms chronic opioid therapy is associated with significant adverse effects underscoring a need to identify alternative interventions in the treatment of PDAC-associated pain PDAC patients frequently suffer from existential distress Demoralization is a form of existential distress that is common among people with serious medical illnesses it is characterized by poor coping with stressful events and a loss of meaning and purpose in life Talk therapy is a form of psychological treatment during which patients discuss problems thoughts and feelings Ketamine has demonstrated efficacy for the treatment of depression suicidality and pain in non-cancer patients This study may help researchers learn whether both ketamine and talk therapy may improve psychosocial distress and pain as well as decreases in opioid analgesic use in patients with PDAC who take opioids for cancer-related pain
Detailed Description:
PRIMARY OUTCOMES
I To assess the feasibility of Meaning and Purpose therapy combined with oral ketamine K-MaP in demoralized participants
SECONDARY OUTCOMES
I To characterize the preliminary safety and tolerability of K-MaP in demoralized participants with pancreatic ductal adenocarcinoma
II To assess the magnitude and durability of improvement from randomization in psychosocial distress
III To assess the magnitude and durability of improvement from randomization in pain
IV To assess the magnitude of change from randomization in opioid analgesic use
V To assess the magnitude and durability of change from randomization in interoceptive awareness
EXPLORATORY OBJECTIVES
I To assess how the participants subjective experiences with ketamine may be related to clinical outcomes
II To assess how participants stage of PDAC may be related to clinical outcomes
III To assess how the participants changes in measures of cardiac interoception following receipt of ketamine may be related to subjective experiences with ketamine and clinical outcomes
OUTLINE
Adult pancreatic ductal adenocarcinoma PDAC participants receiving care at the Helen Diller Family Comprehensive Cancer Center HDFCCC will be randomized in a 11 ratio to one of two double-blinded conditions consisting of a single drug treatment and several therapy sessions for up to 7 weeks Participants will be followed up to 35 days -2 days after ketamine administration
I To assess the feasibility of Meaning and Purpose therapy combined with oral ketamine K-MaP in demoralized participants
SECONDARY OUTCOMES
I To characterize the preliminary safety and tolerability of K-MaP in demoralized participants with pancreatic ductal adenocarcinoma
II To assess the magnitude and durability of improvement from randomization in psychosocial distress
III To assess the magnitude and durability of improvement from randomization in pain
IV To assess the magnitude of change from randomization in opioid analgesic use
V To assess the magnitude and durability of change from randomization in interoceptive awareness
EXPLORATORY OBJECTIVES
I To assess how the participants subjective experiences with ketamine may be related to clinical outcomes
II To assess how participants stage of PDAC may be related to clinical outcomes
III To assess how the participants changes in measures of cardiac interoception following receipt of ketamine may be related to subjective experiences with ketamine and clinical outcomes
OUTLINE
Adult pancreatic ductal adenocarcinoma PDAC participants receiving care at the Helen Diller Family Comprehensive Cancer Center HDFCCC will be randomized in a 11 ratio to one of two double-blinded conditions consisting of a single drug treatment and several therapy sessions for up to 7 weeks Participants will be followed up to 35 days -2 days after ketamine administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-07386 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |