drugset / Trial / NCT05214417

Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy

NCT05214417 ↗

Phase 2 Unknown 120 enrolled The Ketamine Research Foundation
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-05-01
Primary completion
2024-01-01
Completion
2024-03-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 100 mg Intramuscular

Indications

No indication recorded.