Ketamine Therapy Experiential Education Study

This interventional trial (n=500) designated as Ketamine Therapy Experiential Education Study (KTEES1), sponsored by Integrative Psychiatry Institute, investigates the effects of low-dose ketamine, administered intramuscularly to clinicians within a psychedelic-assisted therapy (PAT) training programme.

The primary objective is to assess whether a single ketamine-assisted therapy session enhances competencies necessary for mental healthcare professionals providing PAT.

The study commences in September 2022 and is projected to conclude by September 2024. Participants, aged 18-85 and proficient in English, are those enrolled in the IPI Psychedelic Assisted Therapy Training Program. Those administered ketamine must commit to medication dose and attend all study sessions during the In-Person Experiential Training Weekend, and evaluation instruments. They must refrain from certain medications, alcohol, and psychoactive drugs during the study.

Participants will be divided into two groups: one receiving ketamine administration and the other not, with both groups participating in the PAT training programme. Primary outcomes include self-reported measures of therapeutic efficacy and competency, while secondary outcomes involve personality assessment and perceived mystical experiences.

The study utilises observational methods, allocating participants to groups non-randomly, with no masking involved. The primary completion date is estimated for September 2024.

Topic Healthy Subjects
Compound Ketamine
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 September 2022
End date 30 September 2024
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 500
Sex All
Age 18- 85
Therapy Yes

Trial Details

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.

NCT Number NCT05468047

Sponsors & Collaborators

Integrative Psychiatry Institute
The Integrative Psychiatry Institute (IPI) provides training and education for healthcare professionals in the field of psychedelic-assisted therapy. With a focus on evidence-based practices, IPI's programs are designed to equip therapists, physicians, nurses, and other mental health professionals with the knowledge and skills they need to safely and effectively integrate psychedelic medicines into their practice.

Data attribution

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