Health TrialsbyHealthPanel

Evaluation of Oral THC and CBD in Men and Women

ConditionsDrug AbuseIntoxication by DrugImpairment
Trial statusNot yet recruiting
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

This trial is not recruiting at the moment. You can still explore other options: