S-TACOFS: Evaluation of Smoked THC and CBD in Men and Women
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
This double-blind placebo controlled, within-subject study study will assess testing devices that can measure biochemical markers in oral fluid and neurocognitive-performance markers of recent cannabis use. Other pharmacodynamic effects of inhaled cannabis with CBD and THC will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Placebo Smoked placebo cannabis |
Drug: Placebo Cannabis
Smoked placebo cannabis
|
Experimental: 20 mg CBD Smoked cannabis with CBD |
Drug: 20 mg CBD Cannabis
Smoked cannabis with CBD
|
Experimental: 20 mg CBD + 20 mg THC Smoked cannabis with CBD and THC |
Drug: 20 mg CBD + 20 mg THC Cannabis
Smoked cannabis with CBD and THC
|
Experimental: 20 mg THC Smoked cannabis with THC |
Drug: 20 mg THC Cannabis
Smoked cannabis with THC
|
Outcome Measures
Primary Outcome Measures
- Subjective drug effect ratings of impairment and abuse liability [6 hours]
Peak subjective ratings of drug effects associated with abuse liability and impairment as measured using visual analogue scales (VAS; 1-100mm).
- Pharmacokinetics of THC, CBD and metabolites [6 hours]
Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH after exposure (Tmax)
- Behavioral task performance as assessed by the DRUID App Score [6 hour]
Trough composite scores on the DRUID App
- THC concentrations in oral fluid [6 hour]
Peak levels of THC in oral fluid after exposure
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or non-pregnant and non-lactating females aged 21-55 years
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Report weekly-monthly use of cannabis (≤1 day per week) over the past month prior to screening,
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Not currently seeking treatment for their cannabis use
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Have a Body Mass Index from 18.5 - 34kg/m2.
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Able to perform all study procedures
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Must be using a contraceptive (hormonal or barrier methods)
Exclusion Criteria:
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Meeting DSM-V criteria for moderate to severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine
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Any other Axis I disorder
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Report using other illicit drugs in the prior 4 weeks, other than cannabis.
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Current use of any medications that may affect study outcomes
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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.
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Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
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History of an allergic reaction or adverse reaction to cannabis is exclusionary.
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History of respiratory illness or current respiratory illness
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Currently enrolled in another research protocol
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Not using a contraceptive method (hormonal or barrier methods)
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The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: Ziva Cooper, PhD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-001137