Clinical TrialHealthy VolunteersKetaminePlaceboTerminated

The Effects of Low Dose Ketamine on Cardiovascular Function

This terminated interventional trial (n=6) aimed to investigate the effects of low-dose ketamine on cardiovascular function.

Target Enrollment
6 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

This randomised, triple-masked, crossover Phase I study in six healthy adults assessed how low-dose ketamine affects sympathetic nervous system activity and cardiovascular function compared with saline placebo.

Primary outcome was the effect on muscle sympathetic nervous system activity and blood pressure; the crossover design allowed within-subject comparison between ketamine and isotonic saline.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Low Dose Ketamine

experimental

Single low-dose ketamine administration in crossover design.

Interventions

  • Ketamine
    • single dose

    Ketalar (racemic ketamine); low dose not specified in registry text.

Saline (placebo)

inactive

Isotonic/normal saline placebo comparator.

Interventions

  • Placebo

    Normal saline placebo.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Non-obese (body mass index less than 30 kg/m2)
  • Alternatively permitted if BMI <35 kg/m2 with waist circumference below 88 cm for females and 102 cm for males
  • Systolic blood pressure <140 mmHg
  • Diastolic blood pressure <90 mmHg

Exclusion Criteria

  • 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

Study Details

  • Status
    Terminated
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment6 participants
  • Timeline
    Start: 2020-11-01
    End: 2021-05-28
  • Compounds
    KetaminePlacebo
  • Topic
    Healthy Volunteers

Locations

University of Texas Southwestern Medical Center — Dallas, Texas, United States

Your Library