Trials / Completed
CompletedNCT04199468
THC and Ketamine Effects in Humans: Relation to Neural Oscillations and Psychosis
An Electrophysiological Examination of CB1 and NMDA Receptors in Humans
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Active Delta-9-THC | Active Delta-9-THC (0.015 mg/kg) given intravenously (IV) |
| DRUG | Placebo Delta-9-THC | A placebo dose given intravenously (IV) |
| DRUG | Active Ketamine | Active Ketamine (0.2 mg/kg) given intravenously (IV) |
| DRUG | Placebo Ketamine | A placebo dose given intravenously (IV) |
Timeline
- Start date
- 2019-09-24
- Primary completion
- 2022-06-21
- Completion
- 2022-06-21
- First posted
- 2019-12-16
- Last updated
- 2024-03-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04199468. Inclusion in this directory is not an endorsement.