HealthyPhase 1NCT04429685
The Effects of Low Dose Ketamine on Cardiovascular Function
A Phase 1 study testing Ketamine in people with Healthy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Low dose ketamine is used for pain management and for the treatment of anxiety and depression. Prior studies on low dose ketamine have noted short-term (minutes to hours) increases or decreases in blood pressure. Blood pressure that is too high or too low can be problematic if untreated. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 28 May 2021
- Phase
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-obese (body mass index less than 30 kg/m2)
- alternatively, individuals will be permitted to participate if they have a body mass index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102 cm for males
- Systolic blood pressure <140 mmHg
- Diastolic blood pressure <90 mmHg
Who cannot join
- Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
- Current or previous use of anti-hypertensive medications
- Any known history of renal or hepatic insufficiency/disease
- Pregnancy or breast feeding
- Current smokers, as well as individuals who regularly smoked within the past 3 years
- Individuals with a history of drug abuse
- Individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results, but when the agent is abstained for hours/days/weeks, the repeated drug screen is negative. One example could be an over-the-counter supplement)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Low dose ketamine is used for pain management and for the treatment of anxiety and depression. Prior studies on low dose ketamine have noted short-term (minutes to hours) increases or decreases in blood pressure. Blood pressure that is too high or too low can be problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure. In fact, no prior studies have measured sympathetic nervous system activity after low dose ketamine has been given to an adult. Because sympathetic nervous system activity has a large influence on blood pressure, we need to know how exactly low dose ketamine affects these body systems. Therefore, in this research we will study how low dose ketamine affects sympathetic nervous system activity and cardiovascular function. The results from this research will inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and blood vessels.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline
Saline (placebo)Drug
Saline (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Ketamine | Experimental | Not described Receives: Drug: Ketamine |
| Saline (placebo) | Placebo comparator | Not described Receives: Drug: Saline (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Sympathetic Nerve Activity Burst Frequency
We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography
Measured: This outcome will be assessed within one trial lasting up to approximately five hours
Secondary outcomes (1)
Arterial Blood Pressure
We will measure arterial blood pressure, quantified as systolic, mean, and/or diastolic pressure, using an automated monitor before and after administration of low dose ketamine.
Measured: This outcome will be assessed within one trial lasting up to approximately five hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Nov 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Why it stopped: The focus of the laboratory went a different direction given extramural funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We plan to implement a crossover design. A parallel design is an alternative approach we may consider as the primary outcome is the effect of low dose ketamine on muscle sympathetic nervous system, for which a placebo administration may not be fully necessary.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429685
- Sponsor's protocol ID
- STU-2019-1792
- Status last verified
- May 2024
- First submitted
- 4 Jun 2020
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Dose Ketamine on Cardiovascular Function
- ClinicalTrials.gov ID
- NCT04429685
- Acronym / sponsor ID
- STU-2019-1792
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The focus of the laboratory went a different direction given extramural funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 12 Jun 2020 (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.
Low dose ketamine is used for pain management and for the treatment of anxiety and depression. Prior studies on low dose ketamine have noted short-term (minutes to hours) increases or decreases in blood pressure. Blood pressure that is too high or too low can be problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure. In fact, no prior studies have measured sympathetic nervous system activity after low dose ketamine has been given to an adult. Because sympathetic nervous system activity has a large influence on blood pressure, we need to know how exactly low dose ketamine affects these body systems. Therefore, in this research we will study how low dose ketamine affects sympathetic nervous system activity and cardiovascular function. The results from this research will inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and blood vessels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We plan to implement a crossover design. A parallel design is an alternative approach we may consider as the primary outcome is the effect of low dose ketamine on muscle sympathetic nervous system, for which a placebo administration may not be fully necessary.
| Arm | Type | Receives |
|---|---|---|
| Low Dose Ketamine | Experimental | Drug: Ketamine |
| Saline (placebo) | Placebo comparator | Drug: Saline (placebo) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-obese (body mass index less than 30 kg/m2)
- alternatively, individuals will be permitted to participate if they have a body mass index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102 cm for males
- Systolic blood pressure <140 mmHg
- Diastolic blood pressure <90 mmHg
Key exclusion criteria (7 listed)
- Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
- Current or previous use of anti-hypertensive medications
- Any known history of renal or hepatic insufficiency/disease
- Pregnancy or breast feeding
- Current smokers, as well as individuals who regularly smoked within the past 3 years
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 |
|---|---|---|
| KetamineLow dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline | Drug | Low Dose Ketamine |
| Saline (placebo)Saline (placebo) | Drug | Saline (placebo) |
Primary outcome
Muscle Sympathetic Nerve Activity Burst Frequency
Time frame: This outcome will be assessed within one trial lasting up to approximately five hours
We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography
1 secondary outcome
Arterial Blood Pressure
Time frame: This outcome will be assessed within one trial lasting up to approximately five hours
Results and safety
The study was stopped early (reason given: The focus of the laboratory went a different direction given extramural funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine in people with Healthy, run by University of Texas Southwestern Medical Center 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 7 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: stopped early, as of the sponsor's last update on 21 May 2024. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The focus of the laboratory went a different direction given extramural funding). 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?
Muscle Sympathetic Nerve Activity Burst Frequency (time frame: This outcome will be assessed within one trial lasting up to approximately five hours). 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 May 2024.