Psychedelic ExperiencesEarly Phase 1KTEES1NCT05468047
Ketamine Therapy Experiential Education Study
A Early Phase 1 study testing Ketamine hydrochloride injection in people with Psychedelic Experiences and Therapeutic Alliance, run by Integrative Psychiatry Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychedelic Experiences, Therapeutic Alliance, Psychology, Perceptual
- What is being tested?
- Ketamine hydrochloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: Effects of a Personal Ketamine-assisted Therapy Experience on Clinicians' Therapeutic Competencies Within a Psychedelic-assisted Therapy Training Program
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.
- Being tested
- Ketamine hydrochloride injection
- Keywords
- psychedelic-assisted therapy, therapeutic competency, training program, ketamine, mood disorders
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine hydrochloride injectionDrug
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 group | Role | What they receive |
|---|---|---|
| Ketamine administration | Experimental | 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. Receives: Drug: Ketamine hydrochloride injection |
| No ketamine administration | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Psychotherapists Common Core Questionnaire
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).
Measured: 5 weeks
Counseling Self Estimate Inventory
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.
Measured: 5 weeks
Psychedelic-Assisted Therapist Self-Efficacy Scale
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.
Measured: 5 weeks
Secondary outcomes (3)
Big-Five Inventory-2
Self reported personality questionnaire; Likert scale ranging from 1 (worst outcome) to 5 (best outcome) for each of 60 items.
Measured: 5 weeks
Mystical Experiences Questionnaire
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.
Measured: 3 days
Columbia Suicide Severity Rating Scale- "Baseline" and "Since Last Visit" versions
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychedelic ExperiencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Psychiatry Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468047
- Sponsor's protocol ID
- KTEES1
- Acronym
- KTEES1
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Personal Ketamine-assisted Therapy Experience on Clinicians' Therapeutic Competencies Within a Psychedelic-assisted Therapy Training Program
- ClinicalTrials.gov ID
- NCT05468047
- Acronym / sponsor ID
- KTEES1 / KTEES1
- Keywords
- psychedelic-assisted therapy, therapeutic competency, training program, ketamine, mood disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Integrative Psychiatry InstituteUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine administration | Experimental | Drug: Ketamine hydrochloride injectionThese individuals will be provided a personal ketamine-assisted therapy experience as part of an in-person training weekend within a psychedelic-assisted training program. |
| No ketamine administration | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine hydrochloride injectionIndividuals 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. | Drug | Ketamine administration |
Primary outcome
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.
3 secondary outcomes
Big-Five Inventory-2
Time frame: 5 weeks
Mystical Experiences Questionnaire
Time frame: 3 days
Columbia Suicide Severity Rating Scale- "Baseline" and "Since Last Visit" versions
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine hydrochloride injection in people with Psychedelic Experiences and Therapeutic Alliance, run by Integrative Psychiatry Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Psychotherapists Common Core Questionnaire (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.