NCT05214417

Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy

Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy (KAP) for Patients at End of Life-A Pilot Study for Palliative and Hospice Care

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The Ketamine Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Ketamine Injectable Solution	2 IM ketamine sessions with psychotherapy, spaced 9-15 days apart
OTHER	Naturalistic Control	Continuation of pre-existing conventional treatment

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-01-01
• Completion: 2024-03-31
• First posted: 2022-01-28
• Last updated: 2022-02-25

Regulatory

• FDA-regulated drug study