Evaluating the effects of smoked THC and CBD in adults
Evaluation of Smoked THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women
This study tests how different amounts of smoked THC and CBD affect thinking skills and THC levels in the body for adults who use cannabis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05037487 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the pharmacokinetics and pharmacodynamics of inhaled cannabis containing varying amounts of THC and CBD. It employs a double-blind, placebo-controlled, within-subject design to evaluate biochemical markers in oral fluid and neurocognitive performance related to recent cannabis use. Participants will undergo testing to measure the effects of different cannabis formulations on their cognitive functions and the detection of THC in their system.
Who should consider this trial
Good fit: Ideal candidates are healthy men and non-pregnant, non-lactating women aged 21-55 who use cannabis infrequently.
Not a fit: Patients with moderate to severe cannabis use disorder or other significant substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effects of cannabis on cognitive performance and improve detection methods for recent use.
How similar studies have performed: Other studies have explored the effects of cannabis on cognitive function, but this specific approach to pharmacokinetics and detection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Ziva Cooper, PhD — University of California, Los Angeles
- Study coordinator: Ziva Cooper, PhD
- Email: zcooper@mednet.ucla.edu
- Phone: 310-206-9942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.