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Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy (KRF-EOL)

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ClinicalTrials.gov Identifier: NCT05214417
Recruitment Status : Not yet recruiting
First Posted : January 28, 2022
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
The Ketamine Research Foundation

Tracking Information
First Submitted Date  ICMJE January 17, 2022
First Posted Date  ICMJE January 28, 2022
Last Update Posted Date February 25, 2022
Estimated Study Start Date  ICMJE May 1, 2022
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2022)
  • State-Trait Anxiety Inventory (STAI) Form Y-2 (Trait Only) [ Time Frame: 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) [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2022)
  • STAI (State-Trait Anxiety Inventory) [ Time Frame: 18-32 days ]
    Change in STAI from baseline to conclusion of treatment
  • DADDS (Death and Dying Distress Scale) [ Time Frame: 18-32 days ]
    Change in DADDS from baseline to conclusion of treatment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy
Official Title  ICMJE Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy (KAP) for Patients at End of Life-A Pilot Study for Palliative and Hospice Care
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Illness Terminal
Intervention  ICMJE
  • Drug: Ketamine Injectable Solution
    2 IM ketamine sessions with psychotherapy, spaced 9-15 days apart
  • Other: Naturalistic Control
    Continuation of pre-existing conventional treatment
Study Arms  ICMJE
  • Experimental: KAP (Ketamine-assisted Psychotherapy) Recipients
    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.
    Intervention: Drug: Ketamine Injectable Solution
  • Naturalistic Comparator
    Pre-existing conventional treatment will continue for this group during the study period.
    Intervention: Other: Naturalistic Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2022)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philip E Wolfson, MD 415-550-1700 ketamine.research@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05214417
Other Study ID Numbers  ICMJE KRF-EOL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party The Ketamine Research Foundation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Ketamine Research Foundation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip E Wolfson, MD Ketamine Research Foundation
PRS Account The Ketamine Research Foundation
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP