Recruiting
Phase 1

THC & CBD

Sponsor:

UCLA

Code:

NCT05067387

Conditions

Drug Abuse

Intoxication by Drug

Impairment

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Placebo

THC

CBD

THC + CBD

Study Details

Brief summary:

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.

Conditions

Drug Abuse

Intoxication by Drug

Impairment

Study ID

NCT05067387

Start date

Aug 13, 2026

Status verified date

Sep, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Oral placebo; sesame and MCT oil

experimental: 20 mg THC

THC suspended in sesame oil

experimental: 20 mg CBD

CBD suspended in MCT oil

experimental: 20 mg THC + 20 mg CBD

THC and CBD in sesame and MCT oil

Interventions

Placebo

Oral placebo

THC

Oral THC (20 mg)

CBD

Oral CBD (20 mg)

THC + CBD

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

Primary outcome measure

  • Ratings of subjective drug effects [ Time Frame: 6 hours ]
  • Concentration of THC, CBD and metabolites in whole blood [ Time Frame: 6 hours ]
  • Behavioral task performance as assessed by the DRUID App Score [ Time Frame: 6 hours ]
  • Concentration of THC in oral fluid [ Time Frame: 6 hours ]

Central Contacts and Locations

Central contacts

Ziva Cooper, PhD

310-206-9942zcooper@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ziva Cooper, PhD

310-206-9942zcooper@mednet.ucla.edu

Vince Acebo

310-983-3417vacebo@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • THC
  • CBD
  • Intoxication
  • Impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-09-08.