Evaluation of Oral THC and CBD in Men and Women

Study Overview
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Brief Summary
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The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

Detailed Description
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This double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent THC or CBD use. Other pharmacodynamic effects of oral THC or CBD will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.

Official Title
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Evaluation of Oral THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women

Conditions
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Drug Abuse, Intoxication by Drug, Impairment

Intervention / Treatment
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* Drug: Placebo
* Drug: THC
* Drug: CBD
* Drug: THC + CBD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant and non-lactating females aged 21-55 years Report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening, Not currently seeking treatment for their cannabis use Have a Body Mass Index from 18.5 - 34kg/m2. Able to perform all study procedures Must be using a contraceptive (hormonal or barrier methods) Exclusion Criteria: Meeting DSM-V criteria for moderate to severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine Any other Axis I disorder Report using other illicit drugs in the prior 4 weeks, other than cannabis. Current use of any medications that may affect study outcomes If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures. Pregnancy is exclusionary due to the possible effects of the study medication on fetal development. History of an allergic reaction or adverse reaction to cannabis is exclusionary. History of respiratory illness or current respiratory illness Currently enrolled in another research protocol Not using a contraceptive method (hormonal or barrier methods) The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Oral placebo; sesame and MCT oil | Drug: Placebo<br>* Oral placebo<br>|
| Experimental: 20 mg THC<br>THC suspended in sesame oil | Drug: THC<br>* Oral THC (20 mg)<br>|
| Experimental: 20 mg CBD<br>CBD suspended in MCT oil | Drug: CBD<br>* Oral CBD (20 mg)<br>|
| Experimental: 20 mg THC + 20 mg CBD<br>THC and CBD in sesame and MCT oil | Drug: THC + CBD<br>* Oral THC (20 mg) + CBD (20 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratings of subjective drug effects | Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm). | 6 hours | 
| Concentration of THC, CBD and metabolites in whole blood | Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml | 6 hours | 
| Behavioral task performance as assessed by the DRUID App Score | Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance | 6 hours | 
| Concentration of THC in oral fluid | Liquid chromatography-tandem mass spectrometry | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THC, CBD, Intoxication, Impairment