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Ketamine Therapy Experiential Education Study (KTEES1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05468047
Recruitment Status : Not yet recruiting
First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Integrative Psychiatry Institute

Tracking Information
First Submitted Date  ICMJE July 15, 2022
First Posted Date  ICMJE July 21, 2022
Last Update Posted Date July 21, 2022
Estimated Study Start Date  ICMJE September 2022
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2022)
  • Development of Psychotherapists Common Core Questionnaire [ Time Frame: 5 weeks ]
    Scale measuring perceived determinants of professional development as a therapist; this study uses Subscales 8 (21 questions) and 10-1 (1 question) of the DPCCQ. This multi-dimensional measure of therapist development uses questions based on a Likert scale that range from 0 (worst outcome) to 5 (best outcome), -3 (worst outcome) to 3 (best outcome), and 1 (worst outcome) to 6 (best outcome).
  • Counseling Self Estimate Inventory [ Time Frame: 5 weeks ]
    Scale measuring self-reported measures of general counseling efficacy; Likert scale ranging from 1 (worst outcome) to 6 (best outcome) for each of 37 items.
  • Psychedelic-Assisted Therapist Self-Efficacy Scale [ Time Frame: 5 weeks ]
    Scale designed to assess psychedelic-assisted therapy-related competencies as defined in the IPI PAT Training Program; Likert scale ranging from 1 (worst outcome) to 5 (best outcome) for each of 45 items.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2022)
  • Big-Five Inventory-2 [ Time Frame: 5 weeks ]
    Self reported personality questionnaire; Likert scale ranging from 1 (worst outcome) to 5 (best outcome) for each of 60 items.
  • Mystical Experiences Questionnaire [ Time Frame: 3 days ]
    Self-reported scale that assesses ketamine-associated mystical experience and its impact on personal and professional life; Likert scale ranging from 1 (worst outcome) to 5 (best outcome) for each of 30 items.
  • Columbia Suicide Severity Rating Scale- "Baseline" and "Since Last Visit" versions [ Time Frame: 5 weeks ]
    Self-reported assessment of suicidal ideation and behavior; Yes or No questions assess suicidal ideation and behavior, while Likert scales ranging from 0 (best outcome) to 5 (worst outcome), 1 (best outcome) to 5 (best outcome), or 0 (best outcome) to 2 (worst outcome) for 7 items assess severity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 18, 2022)
Demographic questionnaire [ Time Frame: 1 day ]
Self-reported baseline demographic information about participants that may be associated with outcomes
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ketamine Therapy Experiential Education Study
Official Title  ICMJE Effects of a Personal Ketamine-assisted Therapy Experience on Clinicians' Therapeutic Competencies Within a Psychedelic-assisted Therapy Training Program
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is an observational study following clinicians enrolled in a psychedelic-assisted therapy training program. It will investigate changes in measures of therapeutic efficacy and competency following those who choose to undergo a personal ketamine-assisted therapy experience and those who do not.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Psychedelic Experiences
  • Therapeutic Alliance
  • Psychology, Perceptual
Intervention  ICMJE Drug: Ketamine hydrochloride injection
Individuals will be administered a single dose of sub-anesthetic (0.5-0.75 mg/kg; maximum dose of 60 mg regardless of body weight) ketamine hydrochloride injection intramuscularly as part of a ketamine-assisted therapy experience.
Study Arms  ICMJE
  • Experimental: Ketamine administration
    These individuals will be provided a personal ketamine-assisted therapy experience as part of an in-person training weekend within a psychedelic-assisted training program.
    Intervention: Drug: Ketamine hydrochloride injection
  • No Intervention: No ketamine administration
    These individuals will undergo the same psychedelic-assisted training program as those who receive the ketamine experience and will attend the same in-person training weekend; however, these individuals have opted out of ketamine administration by choice or due to contraindication and will not participate in the personal experience.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2022)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Anyone deemed at medical screening 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05468047
Other Study ID Numbers  ICMJE KTEES1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Integrative Psychiatry Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Integrative Psychiatry Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Integrative Psychiatry Institute
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP