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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2022-06-21

Brief Summary

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The aim of the research protocol is to evaluate cannabinoid-glutamate interactions in humans. As part of this aim the investigators will assess the safety and tolerability of the combination of NMDA antagonist, ketamine, and the cannabinoid, delta-9-tetrahydrocannabinol (THC), in healthy adult subjects, and characterize the interactive effects of ketamine and THC on various electrophysiological (EEG), cognitive, and behavioral outcomes.

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Detailed Description

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The investigators will examine the contributions of the cannabinoid receptor (CB1R) and N-methyl D-aspartate receptor (NMDAR) systems to psychosis in healthy humans beings using THC and ketamine respectively (both alone and in combination). Healthy subjects (n=21) will receive THC (active or placebo) followed by ketamine (active or placebo) in a double blind, randomized, crossover (2x2) design. Psychotomimetic effects will be assessed before and at various time points after the drug infusions. EEG indices of information processing, specifically neural oscillations, will be assessed during peak drug effects.

Conditions

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Cannabis Ketamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Delta-9-THC and Placebo Ketamine

Active IV Delta-9-THC and Placebo Ketamine

Group Type EXPERIMENTAL

Active Delta-9-THC

Intervention Type DRUG

Active Delta-9-THC (0.015 mg/kg) given intravenously (IV)

Placebo Ketamine

Intervention Type DRUG

A placebo dose given intravenously (IV)

Active Delta-9-THC and Active Ketamine

Active IV Delta-9-THC and Active Ketamine

Group Type EXPERIMENTAL

Active Delta-9-THC

Intervention Type DRUG

Active Delta-9-THC (0.015 mg/kg) given intravenously (IV)

Active Ketamine

Intervention Type DRUG

Active Ketamine (0.2 mg/kg) given intravenously (IV)

Placebo Delta-9-THC and Placebo Ketamine

IV Placebo Delta-9-THC and Placebo Ketamine

Group Type EXPERIMENTAL

Placebo Delta-9-THC

Intervention Type DRUG

A placebo dose given intravenously (IV)

Placebo Ketamine

Intervention Type DRUG

A placebo dose given intravenously (IV)

Placebo Delta-9-THC and Active Ketamine

IV Placebo Delta-9-THC and Active Ketamine

Group Type EXPERIMENTAL

Placebo Delta-9-THC

Intervention Type DRUG

A placebo dose given intravenously (IV)

Active Ketamine

Intervention Type DRUG

Active Ketamine (0.2 mg/kg) given intravenously (IV)

Interventions

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Active Delta-9-THC

Active Delta-9-THC (0.015 mg/kg) given intravenously (IV)

Intervention Type DRUG

Placebo Delta-9-THC

A placebo dose given intravenously (IV)

Intervention Type DRUG

Active Ketamine

Active Ketamine (0.2 mg/kg) given intravenously (IV)

Intervention Type DRUG

Placebo Ketamine

A placebo dose given intravenously (IV)

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes