Health TrialsbyHealthPanel

Evaluation of Oral THC and CBD in Men and Women

ConditionsDrug AbuseIntoxication by DrugImpairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Placebo

    Drug

    Oral placebo

  • THC

    Drug

    Oral THC (20 mg)

  • CBD

    Drug

    Oral CBD (20 mg)

  • THC + CBD

    Drug

    Oral THC (20 mg) + CBD (20 mg)

Treatment groups

22 Participants
are divided into 4 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: 20 mg THCExperimental treatment 1 intervention
Group C: 20 mg CBDExperimental treatment 1 intervention
Group D: 20 mg THC + 20 mg CBDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6 hours
2

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

Time frame
6 hours
3

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

Time frame
6 hours
4

Concentration of THC in oral fluid

Liquid chromatography-tandem mass spectrometry

Time frame
6 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov
Apply now