Clinical TrialPalliative & End-of-Life DistressKetamineUnknown status

Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy

Randomised, double-blind, parallel trial (n=120) comparing two IM ketamine sessions with psychotherapy versus a naturalistic comparator in people with terminal illness; primary outcomes are STAI‑trait and DADDS.

Target Enrollment
120 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Parallel, randomised, double‑blind study across five sites enrolling 120 participants (90 KAP recipients, 30 naturalistic comparators). KAP recipients receive two IM ketamine sessions (maximum 100 mg per session) spaced 9–15 days apart with preparatory and integration psychotherapy.

Assessments occur across a 4–6 week protocol; primary outcomes are change in STAI (trait) and the Death and Dying Distress Scale (DADDS) from baseline to end of treatment, with safety monitoring throughout.

A six‑subject naturalistic comparator cohort at each site continues usual care and completes the same assessments; comparator participants may optionally cross over to KAP after study completion.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

KAP

experimental

Two IM ketamine sessions with preparatory and integration psychotherapy; sessions spaced 9–15 days; max 100 mg IM ketamine per session.

Interventions

  • Ketamine - 100 mg
    via IM• two sessions• 2 doses total

    Sessions spaced 9–15 days; preparatory and integration therapy provided.

Naturalistic comparator

active comparator

Continuation of pre-existing conventional treatment; six-subject naturalistic comparator per site; optional crossover to KAP offered after study.

Interventions

  • Compound

    Naturalistic control — continuation of usual care; offered optional crossover to KAP after study.

Participants

Ages
18 – 85
Sexes
Male & Female

Inclusion Criteria

  • 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) willing to 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.
  • 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.
  • 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 of 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.
  • 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 would, in the opinion of the investigator, interfere with the patient's participation in the study.
  • If receiving medication that may cause blunting of responses (e.g., antipsychotics), exclusion as per PI assessment.
  • Evidence or history of significant cerebrovascular or cardiovascular disease, or any other medical disorder judged by the PI to significantly increase the risk of ketamine administration; baseline heart rate >110 bpm or ≤50 bpm.
  • Renal failure and dialysis.
  • If on oxygen support, receiving more than 4 liters.
  • Experiencing cognitive and/or affective deficits as a result of ongoing chemotherapy that, in the opinion of the investigator, would interfere with participation.
  • Evidence or history of liver disease that would affect metabolism of ketamine (transaminases >3× normal).
  • 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.
  • Any current problem which, in the opinion of the PI, might interfere with participation in the study.
  • Are not able to give adequate informed consent.
  • Patients with 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 Details

  • Status
    Unknown status
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment120 participants
  • Timeline
    Start: 2022-05-01
    End: 2024-03-31
  • Compound
    Ketamine
  • Topic
    Palliative & End-of-Life Distress

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