Evaluation of Smoked THC and CBD in Men and Women

About

Brief 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.

Primary Purpose

Basic science

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

Yes

Minimum Age

21 Years

Maximum Age

55 Years

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.