Drug AbusePhase 1O-TACOFSNCT05067387
Evaluation of Oral THC and CBD in Men and Women
A Phase 1 study testing THC, CBD and THC + CBD in people with Drug Abuse and Intoxication by Drug, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse, Intoxication by Drug, Impairment
- What is being tested?
- THC, CBD and THC + CBD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 15 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Ziva Cooper, PhD, 310-206-9942, zcooper@mednet.ucla.edu
Vince Acebo, 310-983-3417, vacebo@mednet.ucla.edu
About this study
Official title: Evaluation of Oral THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women
The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.
Read the 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 THC or CBD use. Other pharmacodynamic effects of oral THC or CBD will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.
- Conditions
- Drug Abuse, Intoxication by Drug, Impairment
- Being tested
- Placebo, THC, CBD, THC + CBD
- Keywords
- THC, CBD, Intoxication, Impairment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral placebo
THCDrug
Oral THC (20 mg)
CBDDrug
Oral CBD (20 mg)
THC + CBDDrug
Oral THC (20 mg) + CBD (20 mg)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral placebo; sesame and MCT oil Receives: Drug: Placebo |
| 20 mg THC | Experimental | THC suspended in sesame oil Receives: Drug: THC |
| 20 mg CBD | Experimental | CBD suspended in MCT oil Receives: Drug: CBD |
| 20 mg THC + 20 mg CBD | Experimental | THC and CBD in sesame and MCT oil Receives: Drug: THC + CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of subjective drug effects
Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).
Measured: 6 hours
Concentration of THC, CBD and metabolites in whole blood
Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml
Measured: 6 hours
Behavioral task performance as assessed by the DRUID App Score
Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance
Measured: 6 hours
Concentration of THC in oral fluid
Liquid chromatography-tandem mass spectrometry
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start13 Aug 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziva D. Cooper, PhD, University of California, Los Angeles
- Investigators
- Ziva Cooper, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067387
- Sponsor's protocol ID
- 21-007289
- Acronym
- O-TACOFS
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral THC and CBD in Oral Fluid, Pharmacokinetics, and Subjective and Neurocognitive Effects in Men and Women
- ClinicalTrials.gov ID
- NCT05067387
- Acronym / sponsor ID
- O-TACOFS / 21-007289
- Conditions
- Drug Abuse, Intoxication by Drug, Impairment
- Keywords
- THC, CBD, Intoxication, Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.
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 THC or CBD use. Other pharmacodynamic effects of oral THC or CBD will be determined and the pharmacokinetics of THC, CBD, and respective metabolites will be assessed in whole blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOral placebo; sesame and MCT oil |
| 20 mg THC | Experimental | Drug: THCTHC suspended in sesame oil |
| 20 mg CBD | Experimental | Drug: CBDCBD suspended in MCT oil |
| 20 mg THC + 20 mg CBD | Experimental | Drug: THC + CBDTHC and CBD in sesame and MCT oil |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral placebo | Drug | Placebo |
| THCOral THC (20 mg) | Drug | 20 mg THC |
| CBDOral CBD (20 mg) | Drug | 20 mg CBD |
| THC + CBDOral THC (20 mg) + CBD (20 mg) | Drug | 20 mg THC + 20 mg CBD |
Primary outcome
Ratings of subjective drug effects
Time frame: 6 hours
Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).
Concentration of THC, CBD and metabolites in whole blood
Time frame: 6 hours
Peak blood levels of THC, CBD, 11-OH-THC, and THCCOOH as measured in ng/ml
Behavioral task performance as assessed by the DRUID App Score
Time frame: 6 hours
Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance
Concentration of THC in oral fluid
Time frame: 6 hours
Liquid chromatography-tandem mass spectrometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ziva Cooper principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THC, CBD and THC + CBD in people with Drug Abuse and Intoxication by Drug, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziva Cooper, PhD (310-206-9942, zcooper@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratings of subjective drug effects (time frame: 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.