The Effects of Low Dose Ketamine on Cardiovascular Function

NCT04429685 | Terminated Phase 1 FDA Drug

• 1 other identifier: STU-2019-1792
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Muscle Sympathetic Nerve Activity Burst Frequency

  We will measure muscle sympathetic nerve activity (MSNA), quantified as burst frequency and/or incidence, using microneurography

  This outcome will be assessed within one trial lasting up to approximately five hours

Secondary Outcomes (1)

• Arterial Blood Pressure

  This outcome will be assessed within one trial lasting up to approximately five hours

Other Outcomes (1)

• Blood Vessel Diameter

  This outcome will be assessed within one trial lasting up to approximately five hours

Study Arms (2)

Low Dose Ketamine

EXPERIMENTAL

Drug: Ketamine

Saline (placebo)

PLACEBO COMPARATOR

Drug: Saline (placebo)

Interventions

Ketamine DRUG

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

Low Dose Ketamine

Saline (placebo) DRUG

Saline (placebo)

Saline (placebo)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Ketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 12, 2020
• Study Start: November 1, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (1)