Evaluation of Smoked THC and CBD in Men and Women

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of delta-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Dronabinol

Criteria

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.