Evaluation of Smoked THC and CBD in Men and Women (S-TACOFS)
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ClinicalTrials.gov Identifier: NCT05037487 |
Recruitment Status :
Recruiting
First Posted : September 8, 2021
Last Update Posted : June 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Drug Abuse Intoxication by Drug Impairment | Drug: Placebo Cannabis Drug: 20 mg CBD Cannabis Drug: 20 mg CBD + 20 mg THC Cannabis Drug: 20 mg THC Cannabis | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order. |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Evaluation of Smoked THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women |
Estimated Study Start Date : | June 2022 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | November 2024 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Smoked placebo cannabis
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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 |
- Subjective drug effect ratings of impairment and abuse liability [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 hour ]Trough composite scores on the DRUID App
- THC concentrations in oral fluid [ Time Frame: 6 hour ]Peak levels of THC in oral fluid after exposure

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037487
Contact: Ziva Cooper, PhD | 310-206-9942 | zcooper@mednet.ucla.edu |
United States, California | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Ziva Cooper, PhD 310-206-9942 zcooper@mednet.ucla.edu | |
Contact: Vincent Acebo, PhD 310-983-3417 vacebo@mednet.ucla.edu |
Principal Investigator: | Ziva Cooper, PhD | University of California, Los Angeles |
Responsible Party: | Ziva D. Cooper, PhD, Associate Professor, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT05037487 |
Other Study ID Numbers: |
21-001137 |
First Posted: | September 8, 2021 Key Record Dates |
Last Update Posted: | June 13, 2022 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cannabis THC CBD Intoxication Impairment |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Dronabinol Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |