Drug Abuse, Impairment, Intoxication by Drug
Conditions
Keywords
Cannabis, THC, CBD, Intoxication, Impairment
Brief summary
The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of delta-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.
Detailed description
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 cannabis use. Other pharmacodynamic effects of inhaled cannabis with CBD and THC will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.
Interventions
DRUGPlacebo Cannabis
Smoked placebo cannabis
DRUG20 mg CBD Cannabis
Smoked cannabis with CBD
DRUG20 mg CBD + 20 mg THC Cannabis
Smoked cannabis with CBD and THC
DRUG20 mg THC Cannabis
Smoked cannabis with THC
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective drug effect ratings of impairment and abuse liability | 6 hours | Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm). |
| Pharmacokinetics of THC, CBD and metabolites | 6 hours | Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax) |
| Behavioral task performance as assessed by the DRUID App Score | 6 hour | Trough composite scores on the DRUID App |
| THC concentrations in oral fluid | 6 hour | Peak levels of THC in oral fluid after exposure |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZiva Cooper, PhD
University of California, Los Angeles
Outcome results
None listed