Clinical TrialHealthy VolunteersKetaminePlaceboRecruiting

Pharmacology of human decision making – Study of the effects of ketamine on healthy volunteers (18-55) making simple perceptual decisions

This Phase IV, placebo-controlled crossover trial (n=35) will investigate the impact of ketamine on perceptual decision-making in healthy volunteers.

Target Enrollment
35 participants
Study Type
Phase IV interventional
Design
Randomized, single Blind

Detailed Description

Randomised, blinded crossover in healthy volunteers comparing a single subcutaneous ketamine injection (0.7 mg/kg) with saline placebo, separated by a one-week washout.

Participants complete baseline and pre/post testing questionnaires and perform a perceptual decision-making task to assess accuracy and effects of ketamine on decision processes.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single subcutaneous ketamine injection (active arm) in a two-period crossover with one-week washout.

Interventions

  • Ketamine0.7 mg/kg
    via Other• single dose• 1 doses total

    Subcutaneous abdominal injection (0.7 mg/kg).

Placebo

inactive

Saline abdominal injection of equivalent volume (placebo) in crossover.

Interventions

  • Placebo
    via Other• single dose• 1 doses total

    Saline subcutaneous injection of equivalent volume to ketamine condition.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Aged 18–55
  • Right-handed
  • Normal or corrected-to-normal vision (glasses and contact lenses are ok)
  • No knowledge of any reason why they should not be given ketamine

Exclusion Criteria

  • Any cardiac conditions or history of high blood pressure
  • Assessed as having any contraindication to ketamine by our study physician
  • Assessed as suffering from a psychiatric disorder (according to DSM-V criteria) by our study physician
  • History of epilepsy
  • Females not on hormonal contraception
  • Pregnant or currently breastfeeding
  • Personal history of psychiatric or neurological illness
  • Family history of psychotic illness
  • Report any previous usage of antipsychotic or stimulant medication
  • History of significant* drug use
  • 'Significant' defined as (i) use of any illicit substances within the last 6 months; (ii) >5 lifetime intake of any illicit drug, except cannabis; (iii) more than monthly cannabis intake in the last 6 months
  • Current smoker or have smoked more than 5 cigarettes per week in their lifetime
  • Dependent on alcohol and consume more than 24 units/week
  • Currently taking any of the following substances: St. John's Wort, rifampin, grapefruit juice, clarithromycin

Study Details

  • Status
    Recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment35 participants
  • Timeline
    Start: 2024-06-14
    End: 2024-10-01
  • Compounds
    KetaminePlacebo
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

Your Library