The Effects of Low Dose Ketamine on Cardiovascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low Dose Ketamine

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline

Saline (placebo)

Group Type PLACEBO_COMPARATOR

Saline (placebo)

Intervention Type DRUG

Saline (placebo)

Interventions

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Ketamine

Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline

Intervention Type DRUG

Saline (placebo)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes