This randomised, double-blind, placebo-controlled trial (n=120) will investigate the effects of Ketamine-Assisted Psychotherapy (KAP) on patients with terminal illnesses.
Administered by The Ketamine Research Foundation, the study will take place at five locations and involve 18 subjects at each site. Participants will undergo two separate intramuscular ketamine sessions accompanied by psychotherapeutic support over 4-6 weeks.
Assessments will measure changes in anxiety levels and distress related to death and dying. A naturalistic comparator group will also undergo assessments and have the option for crossover KAP treatment.
The primary outcome measures are changes in the State-Trait Anxiety Inventory (trait assessment only) and the Death and Dying Distress Scale. The study aims to evaluate the efficacy of KAP in palliative and hospice care settings.
Trial Details
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.NCT Number NCT05214417