Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy

Phase 2

• Conditions: Illness Terminal
• Interventions: Drug: Ketamine Injectable Solution; Other: Naturalistic Control

• Registration Number: NCT05214417
• Lead Sponsor: The Ketamine Research Foundation

Brief Summary

The Conscious Dying/Conscious Living study will investigate the effect of KAP (ketamine-assisted psychotherapy) on individuals with terminal illness at five separate geographic locations. Two separate IM ketamine sessions will be administered to 18 subjects at each site, with psychotherapeutic support, including preparatory and integrative sessions. Assessments will be administered throughout the course of the protocol, which will take 4-6 weeks to complete, and the primary outcome measures are changes in the STAI (State-trait Anxiety Inventory, trait assessment only) and the DADDS (Death and Dying Distress Scale) from baseline at the beginning of the study to the conclusion of the treatment period. A six-subject naturalistic comparator group at each site will complete the same assessments without intervention, and then will be offered an optional crossover KAP treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-25
• Study Start: 2022-05-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Decision making capacity including conscious awareness and sufficient memory capacity.
• Ability to provide informed consent.
• Understanding of English language and ability to converse.
• 12 months or less life expectancy by prognosis.
• Age 18-85.
• Able to identify one or two Caregiver/Support Person(s) (relative, spouse, close friend, or other caregiver) who willing provide the following functions: 1) to drive the participant home on medication visits (if applicable), 2) to be reached by Clinical Investigator(s) in the event of a subject becoming suicidal or ill, and 3) to provide collateral information as needed. See Appendix D for Consent form.
• Have significant anxiety about impending death with a STAI Trait score of 45 or greater.
• If the individual has a documented history of anxiety disorder, the patient and investigator are in agreement that the individual's present anxiety is primarily resultant from or exacerbated by their illness and approaching death.
• May continue but not change psychiatric medications during the course of the study.
• May continue but not change therapists during the course of the study.
• Willing to refrain from using stimulants, anxiolytics, and PI designated medications during the day of the study sessions.
• Willing to refrain from using alcohol and marijuana for 24 hours before-- and the day of study sessions.
• Agrees to refrain from the use of any psychoactive drug during the course of the study., this referring to "Any drug that affects the nervous system leading to any or all of the following: Alterations in mood, awareness, thoughts, feelings, perception, cognition, or behavior.
• If necessary, are willing to be contacted via telephone on a daily basis by one of the therapists for a week after each experimental session

Exclusion Criteria

• Clinical evidence of significant dementia or other cognitive impairment.
• Hypertension: Defined as Systolic greater than 145 or Diastolic greater than 95.
• History in intracranial bleeds or stroke.
• History of seizures.
• Known hypersensitivity to ketamine
• Class 2 or above heart disease.
• Below age 18 or above age 85.
• Subjects who are assessed to be at high risk of suicidal ideation or behavior.
• Have a history (or current diagnosis) of any of the following psychiatric disorders: a primary psychotic disorder, bipolar affective disorder type 1, dissociative identity disorder, an eating disorder (i.e., anorexia or bulimia), or a personality disorder that, in the opinion of the investigator, would interfere with the patient's participation in the study.
• IF receiving medication that may cause blunting of responses, and diminished affect such as antipsychotics, exclusion will be as per the evaluation of the PI and staff.
• Have evidence or history of significant (controlled or uncontrolled) cerebrovascular or cardiovascular disease, or any other medical disorder judged by the Principal Investigator(s) to significantly increase the risk of ketamine administration. Baseline Heart rate 110BPM or less; Greater than 50 BPM.
• Renal failure and dialysis.
• If on oxygen support, receiving no more than 4 liters
• Are experiencing cognitive and/or affective deficits as a result of ongoing chemotherapy that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study.
• Have evidence or history of liver disease that would affect metabolism of ketamine. Transaminases do not exceed 3 times normal range
• Meet DSM-V criteria for substance abuse or dependence for any substance in the past sixty days except caffeine or nicotine-with the exception of opiates used prn for pain.
• Pregnant and Lactating Women
• Have any current problem, which in the opinion of the Principal Investigator(s) might interfere with participation in the study
• Are not able to give adequate informed consent
• Patients referred to our study who have by history electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval will be excluded as ondansetron may need to be used.
• Patients who are allergic to ondansetron will be excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KAP (Ketamine-assisted Psychotherapy) Recipients	Ketamine Injectable Solution	Two separate IM ketamine injection sessions, with possible multiple doses administered at each session not to exceed 100 mg IM ketamine total for the session.
Naturalistic Comparator	Naturalistic Control	Pre-existing conventional treatment will continue for this group during the study period.

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI) Form Y-2 (Trait Only)	18-32 days	Change in STAI (trait only) from baseline to conclusion of treatment (minimum 20/maximum 80, higher scores indicate increased anxiety and a worse outcome)
Death and Dying Distress Scale (DADDS)	18-32 days	Change in DADDS from baseline to conclusion of treatment (minimum 0/maximum 75, higher scores indicate increased death anxiety and a worse outcome)