Pain, Acute Clinical Trial
Official title:
Pilot Study of Ketamine-assisted Talk Therapy for Demoralization in Patients With Pancreatic Ductal Adenocarcinoma and Pain
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.
PRIMARY OUTCOMES: I. To assess the feasibility of Meaning and Purpose therapy combined with 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 participant's subjective experiences with ketamine may be related to clinical outcomes. II. To assess how participants' stage of PDAC may be related to 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 1:1 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. ;
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