Ketamine Therapy Experiential Education Study (NCT05468047) | Clinical Trial Compass
UnknownEarly Phase 1
Ketamine Therapy Experiential Education Study
500 participantsStarted 2022-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-85 years old
* Are proficient in reading and speaking English
* Competent in decision making capacity
* Enrolled in the IPI Psychedelic Assisted Therapy Training Program
* For those being administered ketamine, able and willing to commit to medication dose, attending all study sessions during the In-Person Experiential Training Weekend, and evaluation instruments
* For those being administered ketamine, willing to refrain from using stimulants, anxiolytics during the day of the study session
* May continue but not change psychiatric medications during the course of the study
* Agree to refrain from using stimulants, anxiolytics during the day of the study sessions
* Agree to refrain from alcohol and marijuana for 24 hours before and the day of study sessions
* Agree to refrain from the use of any psychoactive drug during the course of the study
* Willing to be recorded by video and audio for safety purposes only
* Agree to not operate a car or any other heavy equipment for the rest of the day after the ketamine administration
* If necessary, are willing to be contacted via telephone on a daily basis by the therapist or team after each experiential session
* Able to identify one or two caregiver support persons who can drive participant home, be reached by the team, and provide collateral information as needed
* Willing to inform the investigator within 48 hours if any medical conditions occur or procedures are planned
Exclusion Criteria:
* Unab…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Development of Psychotherapists Common Core Questionnaire