Acute Stress DisorderPhase 4NCT04769297
Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
A Phase 4 study testing Sublingual Micro-Dose Ketamine in people with Acute Stress Disorder, run by Limbic Medical at 1 site in United States.
Trial summary
A retrospective chart review of an open-label trial of low-dose ketamine administered to front-line Healthcare workers who were identified as experiencing acute stress disorder due to the COVID-19 Pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Stress Disorder
- What is being tested?
- Sublingual Micro-Dose Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to Apr 2021
- Phase
- Phase 4
- 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
- Greater than 18 years of age
- Demonstrate capacity to consent to the study
- A Frontline Health Care Worker-defined as any EMS personnel (firefighter, EMT, flight nurse, etc.), or any hospital-based worker (particularly in the ED, ICU, or OR) such as an RN, MD/DO, or non-clinical support staff (EVS, etc.)
- Experiencing acute stress disorder as determined by clinically validated screening tools -
Who cannot join
- Currently on prescription medications for psychiatric issues
- Currently pregnant or breastfeeding or actively trying to get pregnant
- History of seizure disorder, liver disease, or psychosis/mania
- Uncontrolled Hypertension
- Physician discretion: any condition deemed inappropriate that will increase the risk -
Trial locations and contacts
1 site in 1 country.
About this study
A retrospective chart review of an open-label trial of low-dose ketamine administered to front-line Healthcare workers who were identified as experiencing acute stress disorder due to the COVID-19 Pandemic.
Read the detailed description
An investigation of a novel, off-label use of an FDA approved drug (ketamine) in a low(micro) dose sublingual formulation of ketamine provided to front-line healthcare workers who were identified as suffering from acute stress disorder.
The study was conducted completely virtually via real-time telemedicine for physician visits and via asynchronous interaction for outcomes data collection.
Patients self-referred to the study via email outreach, and diagnosis was confirmed by medically validated screening assessments and study physician confirmation.
Once treatment was initiated, patients were seen via live telemedicine every 40 days while treatment response/outcomes data was collected weekly and monthly.
Patients were treated up to 120 days.
- Conditions
- Acute Stress Disorder
- Being tested
- Sublingual Micro-Dose Ketamine
- Medical subject headings
- Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual Micro-Dose KetamineDrug
daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Micro-Dose Ketamine | Experimental | Ketamine micro-dose 37.5mg compounded sublingual daily administration Receives: Drug: Sublingual Micro-Dose Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-reported outcome measure
Perceived Stress Scale
Measured: up to 120 days
Patient self-reported outcome measure
15-Dimensional Health-Related Quality of Life Questionnaire 15-Dimensional Health-Related Quality of Life Questionnaire
Measured: up to 120 days
Patient self-reported outcome measure
PCL-5 (PTSD checklist for DSM-5)
Measured: up to 120 days
Patient self-reported outcome measure
Physical Health- NIH PROMIS Global
Measured: up to 120 days
Patient self-reported outcome measure
Mental Health- NIH PROMIS Global
Measured: up to 120 days
Patient self-reported outcome measure
Health Perception and Social Roles
Measured: up to 120 days
Patient self-reported outcome measure
Doctor's Note
Measured: up to 120 days
Patient self-reported outcome measure
NIH PROMIS CAT- Depression
Measured: up to 120 days
Patient self-reported outcome measure
NIH PROMIS CAT Neuro-QOL-Anxiety
Measured: up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start15 Apr 2020
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress DisorderStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective, Open-label chart review
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limbic Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Enovex Pharmacy
- Responsible party
- Sponsor
- Investigators
- Andre Atoian, MD, Principal investigator, Limbic Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769297
- Sponsor's protocol ID
- LM-LDK-001
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 24 Feb 2021
- 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 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04769297
- Acronym / sponsor ID
- LM-LDK-001
- Conditions
- Acute Stress Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Limbic MedicalUniversity, hospital or other
- Collaborators
- Enovex Pharmacy
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 24 Feb 2021 (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.
A retrospective chart review of an open-label trial of low-dose ketamine administered to front-line Healthcare workers who were identified as experiencing acute stress disorder due to the COVID-19 Pandemic.
Detailed description
An investigation of a novel, off-label use of an FDA approved drug (ketamine) in a low(micro) dose sublingual formulation of ketamine provided to front-line healthcare workers who were identified as suffering from acute stress disorder.
The study was conducted completely virtually via real-time telemedicine for physician visits and via asynchronous interaction for outcomes data collection.
Patients self-referred to the study via email outreach, and diagnosis was confirmed by medically validated screening assessments and study physician confirmation.
Once treatment was initiated, patients were seen via live telemedicine every 40 days while treatment response/outcomes data was collected weekly and monthly.
Patients were treated up to 120 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective, Open-label chart review
| Arm | Type | Receives |
|---|---|---|
| Sublingual Micro-Dose Ketamine | Experimental | Drug: Sublingual Micro-Dose KetamineKetamine micro-dose 37.5mg compounded sublingual daily administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than 18 years of age
- Demonstrate capacity to consent to the study
- A Frontline Health Care Worker-defined as any EMS personnel (firefighter, EMT, flight nurse, etc.), or any hospital-based worker (particularly in the ED, ICU, or OR) such as an RN, MD/DO, or non-clinical support staff (EVS, etc.)
- Experiencing acute stress disorder as determined by clinically validated screening tools -
Key exclusion criteria (5 listed)
- Currently on prescription medications for psychiatric issues
- Currently pregnant or breastfeeding or actively trying to get pregnant
- History of seizure disorder, liver disease, or psychosis/mania
- Uncontrolled Hypertension
- Physician discretion: any condition deemed inappropriate that will increase the risk -
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 |
|---|---|---|
| Sublingual Micro-Dose Ketaminedaily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic | Drug | Sublingual Micro-Dose Ketamine |
Primary outcome
Patient self-reported outcome measure
Time frame: up to 120 days
Perceived Stress Scale
Patient self-reported outcome measure
Time frame: up to 120 days
15-Dimensional Health-Related Quality of Life Questionnaire 15-Dimensional Health-Related Quality of Life Questionnaire
Patient self-reported outcome measure
Time frame: up to 120 days
PCL-5 (PTSD checklist for DSM-5)
Patient self-reported outcome measure
Time frame: up to 120 days
Physical Health- NIH PROMIS Global
Patient self-reported outcome measure
Time frame: up to 120 days
Mental Health- NIH PROMIS Global
Patient self-reported outcome measure
Time frame: up to 120 days
Health Perception and Social Roles
Patient self-reported outcome measure
Time frame: up to 120 days
Doctor's Note
Patient self-reported outcome measure
Time frame: up to 120 days
NIH PROMIS CAT- Depression
Patient self-reported outcome measure
Time frame: up to 120 days
NIH PROMIS CAT Neuro-QOL-Anxiety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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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.
Andre Atoian, MD principal investigator
Limbic Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sublingual Micro-Dose Ketamine in people with Acute Stress Disorder, run by Limbic Medical at 1 site in United States.
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 4 inclusion and 5 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Patient self-reported outcome measure (time frame: up to 120 days). The study lists 9 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 24 Feb 2021.