Evaluation of Smoked THC and CBD in Men and Women

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Aug 31, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of inhaled cannabis, specifically looking at two important compounds: THC (the chemical that makes you feel high) and CBD (which is thought to have calming effects). The researchers want to understand how these substances are processed in the body and how long they can be detected in oral fluid after smoking. The trial is open to both men and women aged 21 to 55 who use cannabis occasionally, about once a week or less, and are not currently trying to quit.

To participate, you should be in good health, with a Body Mass Index (BMI) between 18.5 and 34, and using a form of birth control if you're a woman. You won’t be eligible if you have a serious cannabis use disorder, any other major mental health issues, or if you've used other illegal drugs recently. If you join the study, you can expect to undergo various assessments to ensure your safety, and you'll be closely monitored during the trial to see how your body reacts to the cannabis.

Gender

ALL

Eligibility 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.