Health TrialsbyHealthPanel

Effects of Cannabidiol (CBD) on a Fixed Dose of Delta-9-tetrahydrocannabinol (THC)

ConditionCannabis Intoxication
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorJohns Hopkins University

About this trial

This study will evaluate the subjective and behavioral effects of cannabis products containing delta-9-tetrahydrocannabinol and cannabidiol

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

at least 21 years old;

be in good general health based on screening procedures (e.g., physical exam, EKG, blood testing, psychiatric evaluation);

have vital signs in normal range;

have not donated blood in past 30 days;

Disqualifiers

psychoactive drug use (aside from nicotine, alcohol, or caffeine) in past month;

current use of over the counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety or pharmacokinetics (PK) of the study drugs;

history of or current evidence of significant medical condition;

evidence of current psychiatric condition (based on MINI);

Trial design

Design model

Crossover

Treatments tested in this trial

  • 0mg THC + 0mg CBD Brownie

    Drug

    Brownie containing no THC and CBD will be self administered through oral ingestion.

  • 10mg THC + 0mg CBD Brownie

    Drug

    Brownie containing 10mg THC and no CBD will be self administered through oral ingestion.

  • 10mg THC + 10mg CBD Brownie

    Drug

    Brownie containing 10mg THC and 10mg CBD will be self administered through oral ingestion.

  • 10mg THC + 50mg CBD Brownie

    Drug

    Brownie containing 10mg THC and 50mg CBD will be self administered through oral ingestion.

  • 10mg THC + 100mg CBD Brownie

    Drug

    Brownie containing 10mg THC and 100mg CBD will be self administered through oral ingestion.

  • 10mg THC + 300mg CBD Brownie

    Drug

    Brownie containing 10mg THC and 300mg CBD will be self administered through oral ingestion.

  • 0mg THC + 300mg CBD Brownie

    Drug

    Brownie containing no THC and 300mg CBD will be self administered through oral ingestion.

Treatment groups

70 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: 0mg THC + 0mg CBDPlacebo comparator 1 intervention
Group B: 10mg THC + 0mg CBDExperimental treatment 1 intervention
Group C: 10mg THC + 10mg CBDExperimental treatment 1 intervention
Group D: 10mg THC + 50mg CBDExperimental treatment 1 intervention
Group E: 10mg THC + 100mg CBDExperimental treatment 1 intervention
Group F: 10mg THC + 300mg CBDExperimental treatment 1 intervention
Group G: 0mg THC + 300mg CBDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Driving performance as assessed by standard deviation of lateral position (SDLP)

The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.

Time frame
Baseline, , 2-, 4-, 6-, 8-hours post dosing.
2

Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)

Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).

Time frame
Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
3

Driving Under the Influence of Drugs (DRUID) application global impairment score

Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).

Time frame
Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
4

Number of Correct Trials on the Digit Symbol Substitution Task (DSST)

Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).

Time frame
Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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