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Status unknownNCT05214417KRF-EOLUpdated Feb 25, 2022

Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy

A Phase 2 interventional study of Ketamine Injectable Solution and Naturalistic Control in Illness Terminal, sponsored by The Ketamine Research Foundation. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-02-25.

Sponsored by The Ketamine Research Foundation · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Illness Terminal

Keywords

  • ketamine
  • ketamine assisted psychotherapy
  • palliative care
  • hospice
  • death and dying
  • conscious dying
  • psychedelic psychotherapy
  • psychedelics
  • end of life
  • life threatening illnesses
03

In context

Lead sponsor

The Ketamine Research Foundation is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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.

    Drug: Ketamine Injectable Solution

  • Other
    Naturalistic Comparator

    Pre-existing conventional treatment will continue for this group during the study period.

    Other: Naturalistic Control

Interventions

  • DrugKetamine Injectable Solution

    2 IM ketamine sessions with psychotherapy, spaced 9-15 days apart

  • OtherNaturalistic Control

    Continuation of pre-existing conventional treatment

06

What researchers measure

Primary outcomes

  1. State-Trait Anxiety Inventory (STAI) Form Y-2 (Trait Only)

    Change in STAI (trait only) from baseline to conclusion of treatment (minimum 20/maximum 80, higher scores indicate increased anxiety and a worse outcome)

    Time frame: 18-32 days

  2. Death and Dying Distress Scale (DADDS)

    Change in DADDS from baseline to conclusion of treatment (minimum 0/maximum 75, higher scores indicate increased death anxiety and a worse outcome)

    Time frame: 18-32 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

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Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05214417
Lead sponsor
The Ketamine Research Foundation
Responsible party
Sponsor
First posted
Jan 28, 2022
Start date
May 1, 2022 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Feb 25, 2022

Study contacts

Philip E Wolfson, MD
Contact
ketamine.research@gmail.com
415-550-1700
Philip E Wolfson, MD
principal investigator · Ketamine Research Foundation

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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