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The Effects of Low Dose Ketamine on Cardiovascular Function

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Terminated
Phase 1

Conditions

Healthy

Treatments

Drug: Saline (placebo)
Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT04429685
STU-2019-1792

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

6 participants in 2 patient groups, including a placebo group

Low Dose Ketamine
Experimental group
Treatment:
Drug: Ketamine
Saline (placebo)
Placebo Comparator group
Treatment:
Drug: Saline (placebo)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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