drugset / Trial / NCT05468047

Ketamine Therapy Experiential Education Study

NCT05468047

Phase 0 Unknown 500 enrolled Integrative Psychiatry Institute
Non-randomizedParallel-groupOpen-labelSupportive care

Summary

This study investigates the use of low-dose (0.5-0.75 mg/kg; maximum dose of 60 mg regardless of body weight) ketamine hydrochloride injection, USP administered intramuscularly to healthy clinicians as part of an experiential learning practice within a psychedelic-assisted therapy (PAT) training program. The primary objective of this study is to test the hypothesis that competencies required for mental healthcare professionals providing PAT are enhanced by undergoing a single ketamine-assisted therapy experience, as part of a PAT training program. Primary outcomes of this study are self-reported measures of therapeutic efficacy and competency for providing both general and psychedelic-assisted therapy, measured at baseline and four weeks following an academic in-person retreat with optional ketamine administration. Secondary endpoints include measures of personality and magnitude of perceived mystical experiences. Individual changes in scores across time will be calculated, and differences in therapeutic efficacy and competency between clinician trainees who choose to participate in a personal ketamine-assisted therapy session and those who do not will be assessed.

Timeline

Start
2022-09
Primary completion
2024-09
Completion
2024-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.5 mg/kg Intramuscular
Subject Ketamine Small molecule 0.75 mg/kg Intramuscular

Indications