Evaluation of Oral THC and CBD in Men and Women (O-TACOFS)

University of California, Los Angeles (UCLA)

Status and phase: Not yet enrolling; Phase 1

Conditions: Intoxication by Drug; Impairment; Drug Abuse

Treatments: Drug: THC; Drug: Placebo; Drug: THC + CBD; Drug: CBD

Study type: Interventional

Funder types: Other

Identifiers

NCT05067387

21-007289

Details and patient eligibility

About

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.

Full 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 THC or CBD use. Other pharmacodynamic effects of oral THC or CBD will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.

Enrollment: 22 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Oral placebo; sesame and MCT oil

Treatment:

Drug: Placebo

20 mg THC

Experimental group

Description:

THC suspended in sesame oil

Treatment:

Drug: THC

20 mg CBD

Experimental group

Description:

CBD suspended in MCT oil

Treatment:

Drug: CBD

20 mg THC + 20 mg CBD

Experimental group

Description:

THC and CBD in sesame and MCT oil

Treatment:

Drug: THC + CBD