Clinical TrialImplementation & Service DeliveryKetamineUnknown status

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.

Target Enrollment
500 participants
Study Type
Phase I observational
Design
Non-randomized

Detailed Description

This study investigates a single sub‑anesthetic intramuscular ketamine experience (0.5–0.75 mg/kg, max 60 mg) offered to clinicians as part of an in‑person experiential PAT training weekend to assess changes in competencies for providing psychedelic-assisted and general therapy.

Primary outcomes are self‑reported measures of therapeutic efficacy and competency measured at baseline and four weeks post‑retreat; secondary outcomes include personality measures and magnitude of perceived mystical experiences, with comparisons between those who choose ketamine and those who do not.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine administration

experimental

Personal ketamine-assisted therapy experience delivered during an in-person training weekend.

Interventions

  • Ketamine0.5 - 0.75 mg/kg
    via IM• single dose• 1 doses total

    Sub‑anesthetic 0.5–0.75 mg/kg IM; maximum 60 mg regardless of body weight.

No ketamine administration

waitlist

Participants who opt out of or are contraindicated for ketamine; attend same training but do not receive ketamine.

Participants

Ages
18 – 85
Sexes
Male & Female

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

  • Unable to provide informed consent
  • Anyone currently taking medications contraindicated for ketamine, such as benzodiazepine or lamotrigine
  • Medically unfit for ketamine exposure including but not limited to prior history of psychotic disorder
  • Prior history of unstable bipolar disorder
  • Prior history of personality disorder
  • Prior history of ketamine use disorder
  • Active substance use disorder
  • Untreated migraine headaches
  • Uncontrolled hypertension
  • Cardiovascular disease without approval of physician of record
  • Active or recent suicidal ideation
  • Pregnancy

Study Details

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