Evaluation of Oral THC and CBD in Men and Women

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Sep 23, 2021

Keywords

ClinConnect Summary

This clinical trial is looking to understand how oral forms of THC (the chemical in cannabis that can make you feel high) and CBD (another compound in cannabis that doesn't cause a high) work in the body. Researchers want to see how these substances are processed after being taken by mouth and how they can be detected in saliva after someone has smoked cannabis. The study is not yet recruiting participants, but it aims to include men and women between the ages of 21 and 55 who have used cannabis occasionally in the past month but are not looking for treatment for their use.

To participate, you must be a male or a non-pregnant, non-breastfeeding female within the specified age range and have a healthy body weight. You should also be using a form of contraception, such as birth control pills or condoms. However, if you have a history of serious issues related to cannabis use, certain mental health conditions, or any significant health problems that could make participation risky, you may not be eligible. Participants will experience a series of study procedures, which will help researchers gather important information about the effects of THC and CBD.

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.