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Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy

NCT05214417 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-02-25

No results posted yet for this 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.

Conditions

  • Illness Terminal

Interventions

DRUG

Ketamine Injectable Solution

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

OTHER

Naturalistic Control

Continuation of pre-existing conventional treatment

Sponsors & Collaborators

  • The Ketamine Research Foundation

    lead OTHER

Principal Investigators

  • Philip E Wolfson, MD · Ketamine Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-01-01
Completion
2024-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05214417 on ClinicalTrials.gov