Clinical TrialNeuroimaging & Brain MeasuresPlaceboPlaceboPlaceboKetaminePlaceboPlaceboPlaceboKetamineCompleted

THC and Ketamine Effects in Humans: Relation to Neural Oscillations and Psychosis

Double-blind, randomised 2×2 crossover study in healthy adults (n=22) testing IV Delta-9-THC (0.015 mg/kg) and IV ketamine (0.2 mg/kg) alone and combined with EEG and psychotomimetic outcomes.

Target Enrollment
22 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Healthy volunteers receive IV Delta-9-THC (0.015 mg/kg) and IV ketamine (0.2 mg/kg) in a double-blind, randomized 2×2 crossover; each session pairs THC (active or placebo) followed by ketamine (active or placebo).

Primary outcomes include EEG measures of neural oscillations during peak drug effects and psychotomimetic/cognitive assessments to probe CB1R and NMDAR contributions to psychosis-like phenomena.

Study Arms & Interventions

Active THC + Placebo Ketamine

experimental

Active IV Delta-9-THC and placebo IV ketamine (one combination condition of the 2×2 crossover).

Interventions

  • Placebo0.015 mg/kg
    via IV• single dose

    Active Delta-9-THC 0.015 mg/kg IV

  • Placebo
    via IV• single dose

    Placebo ketamine IV

Active THC + Active Ketamine

experimental

Active IV Delta-9-THC and active IV ketamine (one combination condition of the 2×2 crossover).

Interventions

  • Placebo0.015 mg/kg
    via IV• single dose

    Active Delta-9-THC 0.015 mg/kg IV

  • Ketamine0.2 mg/kg
    via IV• single dose

    Active ketamine 0.2 mg/kg IV

Placebo THC + Placebo Ketamine

experimental

Placebo IV Delta-9-THC and placebo IV ketamine (control condition).

Interventions

  • Placebo
    via IV• single dose

    Placebo Delta-9-THC IV

  • Placebo
    via IV• single dose

    Placebo ketamine IV

Placebo THC + Active Ketamine

experimental

Placebo IV Delta-9-THC and active IV ketamine (one combination condition of the 2×2 crossover).

Interventions

  • Placebo
    via IV• single dose

    Placebo Delta-9-THC IV

  • Ketamine0.2 mg/kg
    via IV• single dose

    Active ketamine 0.2 mg/kg IV

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. 18 to approximately 45 years old
  • 2. Good physical and mental health as determined by history, the Structured Clinical Interview for DSM-5 TR (SCID-NP) and collateral information, physical and laboratory examinations, ECG and vital signs.
  • 3. Weight of 100 kg (220.46 lbs.) or less (inclusive).

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Unstable serious medical conditions. At the discretion of the investigator, subjects with unstable medical conditions that may necessitate changes in medical treatment and hence influence study outcomes will be excluded.
  • 2. Uncontrolled hypertension, long QT syndrome, and seriously abnormal EKG results. EKG abnormalities will be reviewed by the PI and eligibility decisions will be made at the discretion of the PI.
  • 3. A hearing deficit in greater than one band in an ear detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated)
  • 4. Positive pregnancy test

Study Details

Locations

VA Connecticut Healthcare System — West Haven, Connecticut, United States

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